Haemophilus influenzae b and neisseria meningitidis c conjugate vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing Haemophilus type b polysaccharide 5 micrograms and Neisseria Meningitidis group C polysaccharide 5 micrograms conjugated to tetanus toxoid.
Drugs List
Therapeutic Indications
Uses
Immunisation against haemophilus influenzae type B invasive disease
Meningococcal meningitis group C -prophylaxis
Prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (Men) in children from the age of 2 months to 2 years.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Dosage
Children
National guidelines: Primary immunisation should consist of one dose of 0.5ml of meningococcal group C conjugate vaccine given at 3 months of age.
A booster dose is recommended at 12 to 13 months of age (combined with haemophilus influenzae type b vaccine) and a second booster dose at 13 to 15 years of age.
Manufacturers recommend:
Three dose primary vaccination: Children aged 2 months to 12 months
Three doses, each of 0.5ml, should be given with an interval of at least one month between doses.
Two dose primary vaccination: Children aged 3 months to 12 months
Two doses, each of 0.5ml, may be given with an interval of at least two months between doses.
Preterm infants born between 25 weeks and 36 weeks of gestational age
Three doses, each of 0.5ml, should be given from 2 months up to 12 months of age with an interval of at least two months between doses.
It is recommended that infants who receive this vaccine for the first dose should also receive this vaccine for the second and third doses of the primary vaccination course.
Booster vaccination
Children who received an acellular pertussis combination vaccine containing Hib in the primary infant immunisation series should receive the Hib booster before the age of 2 years.
A single 0.5ml dose may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series.
The timing of the booster dose should be in accordance with available official recommendations and would usually be given from the age of 12 months onwards and at least six months after the last priming dose, before the age of 2 years. In children primed with two doses, the timing of the booster should be at least five months after the last priming dose.
Additional Dosage Information
Invasive Haemophilus influenzae type b disease
After recovery from infection, unimmunised and partially immunised index cases under 10 years of age should complete their age-specific course of immunisation. Previously vaccinated cases under 10 years of age should be given an additional dose of haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine) if Hib antibody concentrations are low or if it is not possible to measure antibody concentrations. Index cases of any age with asplenia or splenic dysfunction should complete their immunisation according to the recommendations; fully vaccinated cases with asplenia or splenic dysfunction should be given an additional dose of haemophilus type b vaccine (combined with meningococcal group C conjugate vaccine) if they received their previous dose over 1 year ago.
Asplenia, splenic dysfunction or complement deficiency
Patients under 2 years should be vaccinated according to the standard Immunisation Schedule. The booster dose of haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine), given at 12 to 13 months, should be followed at least one month later by one dose of meningococcal A, C, W135 and Y conjugate vaccine). An additional dose of haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine) should be given after the second birthday.
Patients over 2 years should receive one dose of haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine), followed one month later by one dose of meningococcal A, C, W135, and Y conjugate vaccine.
Travel
Individuals travelling to countries of risk should be immunised with meningococcal A, C, W135, and Y conjugate vaccine, even if they have previously received meningitis C conjugate vaccine. For those who have recently received meningococcal group C conjugate, an interval of at least 4 weeks should be allowed before administering the A, C, W135, and Y vaccine.
Administration
For intramuscular administration, preferably in the anterolateral thigh region.
In children 12 to 24 months, the vaccine may be administered in the deltoid region.
Contraindications
Children under 2 months
Severe febrile conditions
Precautions and Warnings
Immunosuppression
Patients over 2 years
Coagulopathy
Hereditary complement deficiencies
Immunodeficiency syndromes
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Vaccine may not be effective in 100% of patients
Do not mix with other vaccines in the same syringe
Do not use if solution is discoloured or particulates are apparent
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Establish full medical history and health status prior to vaccine
Remain alert to possible coincidental meningitis
Risk of apnoea in premature infants - monitor respiration for 72 hours
May cause anaphylactic / anaphylactoid reactions
May interfere with diagnostic antigen tests for 2 weeks post vaccination
Follow national immunisation guidelines
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born less than 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Patients who become complement deficient may require further doses of the vaccine if they have insufficient antibody levels.
Immunisation with this vaccine does not substitute for routine tetanus immunisation.
Patients with familial complement deficiencies and patients receiving treatments that inhibit terminal complement activation are at an increased risk for developing Neisseria Meningitidis group C related invasive disease, even if antibody development has occurred following Haemophilus influenza B and Neisseria Meningitidis C conjugate vaccination.
Pregnancy and Lactation
Pregnancy
Hib-containing vaccines and meningococcal vaccines may be given to pregnant women when protection is required without delay. There is no evidence of risk from vaccinating pregnant women with inactivated viral or bacterial vaccines or toxoids.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Haemophilus influenzae b and neisseria meningitidis group C conjugate vaccine may be used during breastfeeding. There is no evidence of risk from vaccinating those who are breastfeeding with inactivated viral or bacterial vaccines or toxoids.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Allergic reaction
Allergic skin reactions
Anaphylactoid reaction
Apnoea
Crying
Decreased appetite
Dermatitis
Diarrhoea
Dizziness
Drowsiness
Febrile convulsions
Fever
Headache
Hypotonia
Insomnia
Irritability
Local pain (intramuscular injection site)
Local reaction at injection site
Lymphadenopathy
Malaise
Rash
Stinging, redness and swelling at injection site
Urticaria
Vomiting
Effects on Laboratory Tests
A positive urine Hib antigen test can be observed within 1 to 2 weeks following vaccination. Other tests should be performed in order to confirm Hib infection during this period.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111.
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2013
Reference Sources
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
BNF for Children (2012-2013) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Menitorix. GlaxoSmithKline UK. Revised August 2019.
Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: June 18, 2013.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Haemophilus Vaccines. Last revised: August 14, 2012.
Last accessed: June 18, 2013.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Meningococcal Vaccines. Last revised: August 14, 2012.
Last accessed: June 18, 2013.
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