A non-interventional, open observational non-inferiority study in two cluster-assigned cohorts of children aged 14 months into the safety of NeisVac-C® vaccines manufactured at two different production sites and given simultaneously with measles-mumps-rubella vaccine, assessed by web-based intensive monitoring (Peuterprik)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Name of medicine, other:
  NeisVac-C

Population studied

• Short description of the study population:
  Healthy toddlers aged 13-18 months old, eligible to receive MenC and MMR vaccinations according to the Netherlands Immunisation Programme.
• Age groups:
  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  2430

Study design details

• Main study objective:
  to compare the proportions of vaccinees with fever of ≥38ºC within 4 days after injections of the Baxter NeisVac-C® vaccine bulk material produced in Orth/Donau (new, group A) or NeisVac-C® vaccine of which the bulk material was produced in Beltsville (old, group B), and simultaneous MMR vaccine for both groups of NeisVac-C® recipients
• Outcomes:
  Proportions of children with fever (rectally measured body temperature of ≥38.0°C) within 4 days after vaccination with NeisVac-C® and MMR. Proportions of children with solicited other systemic and local reactions within 4 days after vaccination with NeisVac C® and MMR.
• Data analysis plan:
  The primary endpoint of the study, fever cases observed within 4 days after vaccination will be analyzed using logistic regression with vaccination groups (“old” / “new” product) and potential confounders as listed in 5.3 as explanatory factors, applying a log link in order to obtain relative risk estimates at the end. Relative risk and its 95% CI of occurrence of fever cases with the “new” and “old” NeisVac-C® product will be calculated from the regression model assessing a potential increase of fever reactions with the “new” product. If the upper limit of the 95% CI is below 1.5 then the “new” product is considered to be non-inferior to the old one as far as fever reaction is concerned.The secondary endpoints will be analyzed similarly and descriptive without the non-inferiority considerations.

Documents

Study results

PP NeisVacC Study Report Final version 1-1AUG2016

SUMMARY PP NeisVacC Study Final version 1-1AUG2016