All products arre vaccines and are given to healthy volunteers to induce immunological responses to provide protection against: Pediacel - tetanus, diphtheria, polio, pertussis (whooping cough), Haemophilus influenza ttype b (Hib disease) Menjugate and Nies-VacC - meningococcal C disease Prevenar - pneumococcal disease MedDRA version: 9.1 Level: PT Classification code 10027274 Term: Meningococcal infection MedDRA version: 9.1 Level: LLT Classification code 10061353 Term: Pneumococcal infectio
Conditions
Interventions
Trade Name: Prevenar
Product Name: Prevenar
Product Code: EU/1/00/167/001
Pharmaceutical Form: Injection*
Trade Name: Menjugate
Product Name: Menjugate
Pharmaceutical Form: Injection*
Trade Name: Ne
Sponsors
Health Protection Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • No contraindications to vaccination as specified in the “Green Book” – Immunisation Against Infectious Disease, HMSO. • Written informed consent obtained from the parent or legal guardian of the infant • Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunological responses (in order of priority) of subjects when vaccinated under the schedule below in infancy to: • Meningococcal C • Hib • Pneumococcal serotypes (the seven contained in Prevenar) • Diphtheria • Tetanus ;Secondary Objective: To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the MCC vaccine given in infancy To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to the carrier proteins contained in the conjugate vaccines. ;Primary end point(s): The proportion reaching protective titres/concentrations at the four month blood fro MCC and the five month blood for PNC and the geometric mean titres/concentrations at each of these points. 95% confidence intervals will be calculated. For proportions exact confidence intervals will be calculated. For titres data will be logged (base 10) and assuming normality on the log-scale 95% confidence intervals calculated. If for any reason data are clearly not normal then the 95% confidence interval may be calculated after excluding outliers (such as clear non-responders). If a large proportion of the data are non-responders then it may not be possible to calculate geometric means. | — |
Countries
United Kingdom
Outcome results
None listed