5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Meningococcal vaccine
ATC code: J07AH
No clinical efficacy studies have been performed.
The serum bactericidal antibody (SBA) assay referenced in the text below used rabbit serum as a source of complement and strain C11.
Immunogenicity in Infants
A clinical study (n=786) investigated the immune response to a single dose of NeisVac-C given at 4 or 6 months of age as compared to that of two doses at 2 and 4 months of age. All children received a booster dose at 12-13 months of age.
| |||
Proportion of Subjects with Seroprotective antibody titers | |||
|---|---|---|---|
Schedule | post primary (rSBA ≥ 8)* | pre booster (rSBA ≥ 8)** | post booster (rSBA ≥128)* |
Single dose | 99,6 % | 78,9 % | 98,9 % |
Single dose | 99,2 % | 90,7 % | 99,6 % |
Two dose | 99,6 % | 67,8 % | 99,6 % |
Immunogenicity in Toddlers
In a study investigating the immune response of a single dose of NeisVac-C 100% of the toddlers presented with an rSBA titre of at least 1:8.
Immunogenicity in children aged 3.5-6 years
In a study investigating the immune response of a single dose of NeisVac-C 98.6% of the children presented with an rSBA titre of at least 1:8.
Immunogenicity in adolescents aged 13-17 years and adults
In a study investigating the immune response of a single dose of NeisVac-C 100% of adolescents presented with an rSBA titre of at least 1:8.
In a clinical study in adults aged 18 to 64 years, 95.6% not previously vaccinated and 97.1% with a history of previous vaccination with a plain polysaccharide Men C vaccine had SBA titres of at least 1:8 after a single dose of NeisVac-C.
Post-marketing surveillance following an immunisation campaign in the UK
Estimates of vaccine effectiveness from the UK’s routine immunisation programme (using various quantities of three meningococcal group C conjugate vaccines) covering the period from introduction at the end of 1999 to March 2004 demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3, and 4 months). Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67, 99). However, more than one year after completion of the primary series, there was clear evidence of waning protection.
Up to 2007 the overall estimates of effectiveness in age cohorts from 1-18 years that received a single dose of meningococcal group C conjugate vaccine during the initial catch-up vaccination programme in the UK range between 83 and 100%. The data show no significant fall in effectiveness within these age cohorts when comparing time periods less than a year or one year or more since immunisation.
Post-marketing surveillance following immunisation in the Netherlands
In September 2002, the Netherlands implemented routine meningococcal group C vaccination for toddlers at 14 months of age. In addition, between June and November 2002, a catch-up campaign from 1-18 years of age was carried out. The catch-up campaign in the Netherlands covered nearly 3 million subjects (94% coverage). Disease surveillance in the Netherlands where NeisVac-C has been used exclusively in the vaccination programmes revealed that the incidence of meningococcal C disease has decreased sharply.
5.2 Pharmacokinetic properties
Pharmacokinetic studies are not required for vaccines.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of pharmacology, pyrogenicity, single and repeated dose toxicity, or toxicity to reproduction and development.