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Meningitis B vaccination service clinical update

Course Information

  • Estimated Time: 60 minutes.
  • Difficulty: Intermediate.
  • Categories: Shingles.
  • Quiz: Pass the quiz to pass this course.

Please read our CPD disclaimer before enrolling.

Learning objectives

The course is designed to bring you up to date with the clinical aspects of running a meningitis B vaccination service.

Learning objectives for this module include the following:

  • We will help you understand the clinically relevant background information about Meningitis B including the following:
    • Origin.
    • Epidemiology.
    • Signs and symptoms.
    • Transmission.
    • Risk factors.
    • Complications.
    • Bacterial Meningitis in Infants and Children.
    • Glass Test.
  • We will learn about the vaccines currently used to protect people. We will look at the following aspects of the vaccines:
    • Mechanism of action.
    • Allergy.
    • Vaccine warnings.
    • Co-administration with other vaccines.
    • Dosing schedule.
    • Vaccine storage.
    • Preparation of the vaccines.
    • Administration of the vaccines.
    • Adverse reactions.
  • We know that people accessing your Meningitis B vaccination services may have many questions so we have curated a list of frequently asked questions. We will pre-empt some of the questions that patients may ask.

This training must be used in combination with the practical courses (basic life support, anaphylaxis and practical vaccination skills) you are required to complete in order to make a declaration of competence.


Record your CPD

Before starting this course we recommend you reflect on what you know already. The revalidation form below is a useful tool to help you reflect on what you know before commencing the course. We will give you the chance to fill it in at the end so that you can record your learning.

Creating a record of achievement is a very important aspect of continuing professional development so we will give you a chance to complete an assessment at the end too.

If you successfully complete the quiz at the end of the course we will send you a CPD certificate of achievement for this course.Mark Complete


References

  1. Immunisation procedures, The Green Book chapter 4 available here. [accessed 25.6.2021]

MENINGOCOCCAL DISEASE

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Meningococcal disease is caused by a systemic bacterial infection of Neisseria meningitidis, a gram-negative encapsulated bacterium.

There are a number of different strains of meningococci bacteria, divided into distinct groups based on their polysaccharide capsule antigens.

They are classified according to their capsular group with further division according to the type and subtype of outer membrane proteins.

12 capsular serogroups have been identified: A, B, C, E, H, I, K, L, W, X, Y, and Z,

Historically, serogroups B, C, W and Y were the most common in the UK.

Since the introduction of the meningitis C immunisation programme in 1999, serogroup C infections have dramatically reduced and serogroup B now accounts for around 80% of infections.

Since 2009, capsular serogroup W has been responsible for a growing number of UK cases.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here

MENINGOCOCCAL DISEASE – EPIDEMIOLOGY

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Meningococci colonise the nasopharynx and are usually harmless commensal organisms.

Between 5% and 11% of adults and around 25% of teenagers carry the bacteria without any signs or symptoms of disease.

The carriage rate is low in infants and young children.

However, the incidence rate of meningococcal infection is highest in children under 5, with peak incidence occurring in infants under one year.

There is a secondary peak in young people aged 15 to 19 years.

Capsular serogroup B strains account for around 80% of laboratory-confirmed cases.

The annual incidence of meningococcal disease across all age groups is around 2 cases per 100,000 population.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here

ROUTES OF TRANSMISSION

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Transmission is by aerosol, droplet spread or direct contact with respiratory secretions of someone carrying the bacteria.

Transmission usually requires frequent or prolonged close contact.

Meningococcal disease exhibits seasonal variation.

Peak incidence occurs in the winter months, declining to low levels by late summer.

The incubation period for the infection is 2 to 7 days.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

MENINGOCOCCAL DISEASE – RISK FACTORS

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It is not fully understood why disease develops in some individuals but not in others.

Identified risk factors for disease include:

  • Age.
  • Season.
  • Smoking.
  • Recent influenza A infection.
  • Living in ‘closed’ or ‘semi-closed’ communities, such as university halls of residence or military barracks.
  • Splenic dysfunction and people with complement disorders.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

MANAGEMENT OF CLOSE CONTACTS

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Close contacts of people with meningococcal disease are at increased risk of developing the disease.

The risk is highest in the first seven days of illness in the index case and persists for at least four weeks.

Immediate risk can be managed by the administration of prophylactic antibiotics to the entire household/contact group.

A single dose of ciprofloxacin is recommended; 500mg for an adult, 250mg for children aged five to 12 years and 125mg for children under 5.

Where the capsular serogroup is identified, any unimmunised contacts should be offered an appropriate vaccine in line with UK recommendations.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

We recommend you consult the drug summary of product characteristics and also the BNF for final drug dosing decisions.

MANAGEMENT OF OUTBREAKS

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As well as sporadic, isolated cases, outbreaks of meningococcal disease can occur.

Outbreaks are more likely in closed or semi-closed communities such as schools, universities and military installations.

Advice on the management of specific outbreaks should be obtained from the local Health Protection Team.

All close contacts of confirmed cases should be offered immunisation with an appropriate vaccine.

Advice on the use of meningococcal vaccines in outbreaks is available from:

  • Public Health England, Colindale (Tel: 020 8200 6868)
  • Health Protection Scotland (Tel: 0141 300 1100)
  • Scottish Haemophilus, Legionella, Meningococcus and Pneumococcus Reference Laboratory (Tel: 0141 201 8659)

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

SIGNS AND SYMPTOMS OF MENINGITIS

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Meningococcal infection usually presents as meningitis or septicaemia, or a combination of both.

Onset of disease ranges from mild prodromal symptoms to acute and overwhelming illness.

Meningitis is an infection of the meninges, the protective membranes surrounding the brain and spinal cord. Viral meningitis is not considered in this module.

Symptoms of bacterial meningitis develop suddenly and include:

  • Headache, fever and vomiting.
  • Stiff neck.
  • Muscle or joint pain.
  • Photophobia (aversion to bright lights).
  • Pale, mottled or blotchy skin.
  • Spots or a rash.
  • A rash that does not fade when a glass is rolled over it – see ‘glass test’ (sign of septicaemia).
  • Confusion, drowsiness or unresponsiveness.
  • Seizures.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

MENINGOCOCCAL SEPTICAEMIA AND SKIN RASH

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Along with signs of advancing systemic shock and limb or joint pain, a key diagnostic of septicaemia is a skin rash.

The rash may be non-specific to start with but as the disease progresses it becomes distinctive.

Small red blisters caused by bleeding start to develop, often forming clusters and making the skin blotchy and purple. The rash is described as non-blanching.

Non-blanching means that the red blisters do not fade when pressure is applied.

The best way to see this is with the Glass Test.

Do not wait for a non-blanching rash to develop before seeking help!

Evidence shows that prompt diagnosis and treatment can prevent fatalities.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

GLASS TEST

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To confirm a non-blanching rash, gently pressure can be applied using a drinking glass.

If the red spots remain visible then it is non-blanching and indicative of septicaemia (sepsis).

If the red spots fade and disappear then it may not be septicaemia. However meningococcal rashes can initially fade and later become non-blanching.

The rash may be harder to see on darker skin so apply the glass test to paler areas such as the palms or soles of the feet.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

BACTERIAL MENINGITIS IN INFANTS AND CHILDREN

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In young children, and infants in particular, meningococcal disease may start slowly without any obvious symptoms at first.

Meningococcal infection should be suspected in any young child showing signs of fever, vomiting and irritability.

In infants, if the fontanelle is still open there may be raised pressure resulting in ‘bulging’.

Infants may also refuse feeds, have a high-pitched cry, have a stiff body or be floppy and unresponsive.

The child’s condition may deteriorate rapidly with pale skin, fast heart rate and fast breathing and the emergence of the non-blanching rash.

Children with suspected meningococcal disease, with or without a non-blanching rash, should be urgently transferred to secondary care and given antibiotics at the earliest opportunity (which may be in primary care).Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

COMPLICATIONS OF MENINGOCOCCAL DISEASE

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Historically the UK fatality rate for meningococcal disease was around 10%.

This fell to around 5% by 2011, following the introduction of MenC vaccination in 1999.

The rate is higher for individuals who develop septicaemia as opposed to meningitis alone.

If treated quickly, most people make a full recovery, however, long-term complications are common.

Of those that survive serogroup B infection, up to 36% may develop long-term physical, cognitive or psychological problems.

Around 9% may be left with severe disabilities including:

  • Hearing or sight loss.
  • Limb amputations.
  • Brain damage and/or seizures.
  • Communication problems.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

MENINGOCOCCAL B VACCINES

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All meningococcal vaccines are inactivated and do not contain live organisms. They therefore cannot cause meningococcal disease.

There are two licensed meningococcal B vaccines available in the UK:

Bexsero® – 4CMenB protein vaccine (recombinant, component, adsorbed Men B vaccine).

Trumenba® – recombinant, adsorbed MenB vaccine.

Both vaccines are inactivated, recombinant protein vaccines containing multiple antigenic components.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

LICENSED INDICATIONS

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Bexsero® is indicated for active immunisation of individuals against invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

It is licensed from 2 months of age.

Trumenba® is indicated for active immunisation of individuals against invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

  • It is licensed for adults and children aged 10 years of age and older.
  • Trumenba® is a black triangle medicinal product and subject to additional monitoring.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

BEXSERO® – 4CMENB PROTEIN VACCINE

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Bexsero® is a four-component vaccine containing three N. meningitidis proteins produced by DNA recombinant technology and a preparation of serogroup B outer membrane vesicles (OVM) containing a fourth protein.

The four protein antigens are:

  • Neisseria heparin binding antigen (NHBA) – 50mcg.
  • Neisserial adhesion A (NadA) – 50mcg.
  • Factor H binding protein (fHbp) – 50mcg.
  • PorA P1.4 protein found in the outer membrane vesicles (OVM) – 25mcg.

The three recombinant proteins are produced in E.coli cells and all four components are adsorbed on aluminium hydroxide.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

BEXSERO® – MECHANISM OF ACTION

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Immunisation with Bexsero® stimulates the production of bactericidal antibodies that recognise the vaccine antigens NHBA, NadA, fHbp, and PorA P1.4.

Meningococci that express these proteins are susceptible to killing by vaccine-induced antibodies in association with the complement system.

Not all strains of meningococci express the proteins in sufficient quantities.

The Meningococcal Antigen Typing System (MATS) was developed to relate the antigen profiles of different strains of serogroup B meningococci to the effects of bactericidal antibodies.

Approximately 1000 different isolates of invasive serogroup B meningococci were collected from 5 European countries.

Overall 78% of the isolates were potentially susceptible to vaccine-induced antibodies.

Bactericidal antibodies act in concert with human complement to kill meningococci.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

TRUMENBA® – MENB VACCINE

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Trumenba® is a recombinant, adsorbed Meningitis B vaccine containing two variants of serogroup B factor H binding proteins (fHbp).

The two proteins are produced in E.coli cells by recombinant DNA technology and then lipidated (modified with lipid extensions).

The lipidated proteins are adsorbed on aluminium phosphate.

Other excipients are:

  • Sodium chloride.
  • Histidine.
  • Polysorbate 80 (E433).
  • Water for injections.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

FACTOR H BINDING PROTEIN (FHBP)

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Factor H binding protein (fHbp) is a surface protein that helps meningococcal bacteria avoid the host’s immune defenses.

There are two main antigenically distinct variants found in serogroup B meningococci; subfamily type A and subfamily type B.

In Europe over 96% of group B isolates express either type A or type B proteins on their surface.

The MEASURE assay (Meningococcal Antigen Surface Expression) relates levels of bacterial expression of fHbp to the effect of bactericidal antibodies.

2,150 invasive serogroup B isolates were collected from Europe and North America over a 14 year period.

Over 91% of group B isolates expressed sufficient fHbp to be susceptible to killing by vaccine-induced antibodies.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

TRUMENBA® – MECHANISM OF ACTION

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Trumenba® contains an fHbp variant from each of subfamily type A and subfamily type B proteins.

Immunisation with these proteins stimulates a humoral response from the complement system.

This leads to the production of bactericidal antibodies that recognise the fHbp antigens.

Bactericidal antibodies act in concert with human complement to kill meningococci.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE EFFICACY – BEXSERO®

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The efficacy of Bexsero® has not been tested directly in clinical trials.

Instead, efficacy is inferred by demonstrating an antibody response to each of the vaccine antigens, using human serum as the source of complement.

Serum antibody responses to each of the four vaccine antigens were measured in clinical trial subjects using a Serum Bactericidal Assay (hSBA).

Antibody titres were measured prior to vaccination and at one month after each dose of vaccine, under different dosing schedules.

In infant studies, participants received either two or three primary doses of vaccine and a booster dose 6 months later.

At one month following the booster dose, the percentage of seropositive patients ranged from 83% to 100%. Results for the two-dose and three-dose primary schedules were comparable.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

REAL WORLD EFFICACY – BEXSERO®

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Bexsero® was introduced into the UKs national immunisation programme (NIP) in September 2015 using a two-dose schedule plus booster in infants.

Public Health England conducted a 3 year observational study on a national level.

After three years of the programme, there was a statistically significant reduction of 75% in cases of meningococcal disease caused by serogroup B.

The effect is observed for all vaccine-eligible infants, irrespective of the individual vaccination status.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE EFFICACY – TRUMENBA®

Back to: Meningitis B vaccination service clinical update

The efficacy of Trumenba® has not been tested directly in clinical trials.

Instead, efficacy is inferred by demonstrating an antibody response to each of the vaccine antigens, using human serum as the source of complement.

Serum antibody responses to the two vaccine antigens were measured in clinical trial subjects using a Serum Bactericidal Assay (hSBA).

Antibody titres were measured prior to vaccination and after the final dose in two- or three-dose schedules.

Across all studies the majority of subjects, ranging from 71.3% to 99.4%, achieved sufficient antibody titres against the vaccine antigens.

There is no data for immunocompromised patients or adults over 65 years of age and limited data for adults aged 40-64.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

CONTRA-INDICATIONS

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There are very few individuals who cannot receive meningococcal vaccine.

The only contra-indications to Bexsero® and Trumenba® are:

  • Confirmed anaphylactic reaction to a previous dose of vaccine.
  • Confirmed anaphylactic reaction to any excipient or component of the vaccine.

When there is any doubt, appropriate advice should be sought from a consultant rather than withhold immunisation.

Bexsero® may contain traces of kanamycin (<0.01 mcg/dose) used early in the production process. The tip cap of the syringe may contain natural latex rubber, although the risk of developing allergic reactions is very small.

Trumenba® contains polysorbate 80 as an excipient, an ingredient commonly found in foods and medicines that may cause PEG-related allergy in a minority of individuals.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE WARNINGS

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If an individual is acutely unwell, immunisation should be postponed until they have recovered fully. This is to avoid confusing signs or symptoms of acute illness with the adverse effects of the vaccine.

Minor illness, such as a cold, without fever or systemic upset is not a reason to postpone vaccination.

Pregnancy is not a contra-indication to vaccination. There is little data on the use of either vaccine in pregnancy or breast-feeding but there is no evidence of any risk from inactivated or bacterial vaccines or toxoids.

Vaccination should not be withheld from pregnant women when there is a clear risk of exposure to meningococcal disease.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

CO-ADMINISTRATION WITH OTHER VACCINES

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Meningococcal B vaccines can be given at the same time as other vaccines such as pneumococcal, measles, mumps and rubella (MMR), diphtheria, tetanus, pertussis, polio and Hib.

Vaccines given concomitantly should be administered at different sites, preferably in different limbs.

There is an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero® is co-administered with the above vaccines.

  • Prophylactic paracetamol is recommended when Bexsero® is administered to infants with other routine vaccinations at 2 and 4 months.

In addition to the above vaccines, Trumenba® can be given concomitantly with Quadrivalent Human Papillomavirus vaccine (HPV4) and Meningococcal Serogroups A, C, W, Y conjugate vaccine.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

DOSAGE SCHEDULE – BEXSERO®

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Meningitis B vaccine is given as part of the UK routine childhood immunisation programme using Bexsero®.

One dose (0.5ml) of Bexsero® is given to babies at 8 weeks, 16 weeks and 12 months of age.

Children who were not immunised in infancy can receive a two-dose primary schedule, given at least 2 months apart, followed by a third booster dose after an interval determined by age.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

NHS: Health A–Z: MenB vaccine overview; Last updated 30 June 2021; available here.

NATIONAL IMMUNISATION PROGRAMME

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The aim of the UK meningococcal immunisation programme is to protect directly or indirectly those at greatest risk of meningococcal disease.

The routine schedule is:

  • 2 months  = First primary dose of MenB as Bexsero®
  • 4 months   = Second primary dose of MenB as Bexsero®
  • 12 months   = Booster dose of MenB as Bexsero® plus primary dose of Hib/MenC conjugate vaccine
  • Around 14 years  = One dose of MenACWY conjugate vaccine

Children and adults with asplenia, splenic dysfunction or complement disorders are at increased risk of invasive meningococcal disease and additional booster doses are recommended to maintain immunity.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

DURATION OF PROTECTION – BEXSERO®

Back to: Meningitis B vaccination service clinical update

Antibody persistence following vaccination with Bexsero® has been evaluated in a trial extension involving 3 to 4 year old children.

The children had been vaccinated 2 to 3 years earlier with either a two-dose or three-dose primary schedule and a booster.

The percentage of seropositive subjects in the two-dose cohorts ranged from 35% to 91%, and in the three-dose cohorts from 36% to 84%.

In the same study a further dose of Bexsero® was given (2 to 3 years after the booster dose). After this the percentage of subjects with antibodies to all vaccine antigens ranged from 81% to 100%, demonstrating robust immunological memory at age 3-4.

This would suggest that immunity may persist for the first five years of life when incidence is at its highest.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

DOSAGE SCHEDULE – TRUMENBA®

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Trumenba® is licensed from 10 years of age.

The primary schedule for Trumenba® is either:

  • 2 doses: (0.5 ml each) administered at a 6 month interval, OR
  • 3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose (0.5 ml) at least 4 months after the second dose.

Safety and efficacy of Trumenba® in children younger than 10 years of age have not been established.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

DURATION OF PROTECTION – TRUMENBA®

Back to: Meningitis B vaccination service clinical update

Antibody persistence following vaccination with Trumenba® was demonstrated in a follow-up study where subjects attended visits for four years after their primary dose schedule.

Blood samples were tested for antibodies and a booster dose of Trumenba® was given in year 4.

Four years after the primary schedule the percentage of subjects with sufficient antibody titres ranged from 37% to 56%, depending on the reference serogroup B strain.

Subjects were tested again at one month following the booster dose. The percentage of subjects with sufficient antibody titres ranged from 85% to 100%. This suggests robust immunological memory persists for at least four years.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE ADMINISTRATION

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As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Vaccination should be postponed in subjects suffering from an acute severe febrile illness.

The presence of a minor infection, such as a cold, should not delay vaccination.

Vaccines are for prophylactic use only and not intended for the treatment of existing clinical disease.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

VACCINE ADMINISTRATION – ROUTES OF INJECTION

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Bexsero® is given by deep intramuscular (IM) injection, preferably in the anterolateral aspect of the thigh in infants and young children, or the deltoid muscle of the upper arm in older children or adults.

Trumenba® is given by intramuscular (IM) injection, preferably in the deltoid muscle of the upper arm.

Intramuscular injection is recommended to minimise injection-site reactions.

Individuals with bleeding and coagulation disorders should be injected following local guidelines.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE STORAGE

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Bexsero® and Trumenba® should be stored in the original packaging at +2°C to +8°C and protected from light until use.

Trumenba® syringes should be stored horizontally in the refrigerator to minimise the re-dispersion time.

All vaccines are sensitive to some extent to heat and cold. Effectiveness may be reduced if stored at incorrect temperatures.

Freezing may cause loss of potency for some vaccines and can cause hairline cracks in the container.

Store in a refrigerator (+2°C to +8°C).

Do not freeze.

Store in the original package in order to protect from light.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE PRESENTATION – BEXSERO®

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Bexsero® is supplied in pre-filled syringes that do not require reconstitution before use.

The prefilled syringe contains 0.5ml of a white opalescent suspension.

After storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.

Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension.

The vaccine should be visually inspected for particulate matter and discoloration prior to administration.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

VACCINE PRESENTATION – TRUMENBA®

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Trumenba® is supplied in pre-filled syringes that do not require reconstitution before use.

The prefilled syringe contains 0.5ml of a white liquid suspension.

During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension.

Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white suspension is obtained.

Do not use the vaccine if it cannot be re-suspended.

The vaccine should be visually inspected for particulate matter and discoloration prior to administration.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

ADVERSE REACTIONS – BEXSERO®

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The safety of Bexsero® was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects from 2 months of age.

The most common adverse reactions observed in adolescents and adults were pain at the injection site, malaise and headache.

In children aged up to 10 years:

Very common side-effects (> 1 in 10) include:

  • Fever (≥38°C).
  • Injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), redness, swelling, induration and irritability.
  • Rash (children aged 12 to 23 months) (uncommon after booster).
  • Diarrhoea, vomiting (uncommon after booster).
  • Eating disorders (refusal of feeds etc) Sleepiness, unusual crying, headache, joint pain.

Common side-effects (< 1 in 10) include:

  • Rash (children 2 to 10 years of age).

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

ADVERSE REACTIONS – BEXSERO®

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In clinical studies in infants, fever was reported in 69% to 79% of subjects when Bexsero was co-administered with routine vaccines.

JCVI has recommended that paracetamol should be given prophylactically when Bexsero® is given with other routine vaccinations in children under one year or under.

A 2.5ml (60mg) dose of paracetamol (infant paracetamol 120mg/5ml) should be given as soon as possible after vaccination, followed by a second 2.5 ml dose after 4-6 hours and a third 2.5 ml dose 4-6 hours later.

Ibuprofen appears to be less effective at controlling post-vaccination pyrexia and is not recommended.

The immunogenicity of Bexsero® is not affected by paracetamol.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

ADVERSE REACTIONS – TRUMENBA®

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The safety profile of Trumenba® is based on analysis of approximately 16,000 subjects (10 years of age and older) who have been vaccinated with at least 1 dose of Trumenba® in completed clinical studies.

Very common side-effects (more than 1 in 10 people):

  • Injection-site reactions including pain, swelling, redness and induration.
  • Headache, muscle pain or joint pain, fatigue.
  • Diarrhoea, nausea.
  • Chills.

Common side-effects (less than 1 in 10 people):

  • Fever (becomes more likely with decreasing age).
  • Vomiting.

Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

FREQUENTLY ASKED QUESTIONS

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  • What is meningitis?

Meningitis is an infection of the protective membranes that surround the brain and spinal cord. It can be caused by viral or bacterial infections. It is a very serious illness that can quickly become life-threatening or eve fatal. It is most common in children under 5 and teenagers aged 15-19. Prompt recognition of the signs can save lives. Headache, nausea, vomiting, a stiff neck, a dislike of bright lights and a rash that does not disappear under a glass are signs of meningitis. Babies may refuse feeds, cry a lot, look pale or mottled and have a stiff body or be limp and unresponsive. Go straight to hospital if you suspect your child may have symptoms of meningitis.

  • What is meningitis B?

It is a type of bacterial meningitis caused by bacteria called meningococci. There are lots of different strains of the bacteria, each one given a letter to name them. Meningococci group B are responsible for around 80% of bacterial meningitis infections in the UK. Meningitis B vaccination can prevent these infections. Other vaccines are available to protect against other strains of meningococcal bacteria.

  • Who can have meningitis B vaccination?

Meningitis B vaccine is given to babies as part of routine childhood immunisations using Bexsero® vaccine. Alongside other vaccines, Bexsero® is given at 2 months, 4 months and 12-13 months. Children with immune problems may need further booster doses as they get older. Other meningococcal vaccines are given to older children and teenagers. Trumenba® meningitis B vaccine can be given to adults and children aged 10 years or over.

  • Will MenB vaccine stop my child from getting meningitis?

No vaccine is 100% effective and people who have been vaccinated may still get the disease. Meningitis can be caused by different micro-organisms but meningitis B is responsible for more than 80% of cases in the UK. MenB vaccine helps your body make antibodies that can kill the bacteria. Studies have shown that around 90% of group B meningococcal bacteria are susceptible to killing by vaccine-induced antibodies. In clinical trials, between 80% and 100% of subjects produced enough antibodies to kill the bacteria.

  • Can the vaccine cause meningitis?

MenB vaccine does not contain any live organisms so it cannot cause the disease. It contains different bacterial proteins that are recognised by the immune system which then makes antibodies.

  • Should I give my baby a painkiller after their vaccine?

The injection itself can be painful, but a painkiller won’t help. However, there is a high chance your baby may develop a fever after vaccination and you are advised to give 2.5ml (60mg) of paracetamol suspension 120mg/5ml as soon as possible. You can give two further doses every 4-6 hours. Ibuprofen is not as effective as paracetamol in this case and is not recommended.Mark Complete


References

Public Health England (PHE); Meningococcal: the green book, chapter 22; Published 20 March 2013, Last updated 20 September 2016; available here.

NHS: Health A–Z: Meningitis; Last updated 08 March 2019; available here.

Summary of medicinal Product Characteristics (SmPC), Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe; GlaxoSmithKline UK, updated 01-Jan-2021. Accessed online via The electronic Medicines Compendium; available here.

.Summary of medicinal Product Characteristics (SmPC), Trumenba suspension for injection in pre-filled syringe, Meningococcal group B vaccine (recombinant, adsorbed); Pfizer Limited, updated May 2021. Accessed online via The electronic Medicines Compendium; available here.

NHS: Health A–Z: MenB vaccine overview; Last updated 30 June 2021; available here.

FEEDBACK AND POST-COURSE REFLECTIVE REVALIDATION ENTRY

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Congratulations on completing this course. Here is another chance to reflect on and record your learning. We would love to know if your knowledge has improved as a result of completing this course. We also welcome your feedback.

FINAL COURSE ASSESSMENT

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Welcome to the final assessment for this course. We have pulled together all the questions from the course and invite you to take the quiz.

Upon successful completion, you will receive an electronic certificate via email. To achieve the certificate you must achieve at least 80% in the final assessment.