A phase IV study to evaluate the primary and booster immune responses of UK infants receiving a licensed 6-in-1 DTaP/IPV/Hib/HBV vaccine (Infanrix-Hexa) with a 13valent pneumococcal conjugate vaccine and incorporating a randomisation study of a single dose of 3 different meningococcal group C conjugate vaccines at 3 months of age
- Conditions
- Immune response to vaccinesInfections and Infestations
- Registration Number
- ISRCTN27374886
- Lead Sponsor
- Health Protection Agency (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 171
1. Male or female infants born at term (at least 37 weeks gestation) who are aged <10 weeks and have not yet received their primary immunisations
2. With written informed consent obtained from the parent or legal guardian of the infant to participate in the study
3. Do not fulfil any of the exclusion criteria
1. History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B
2. History of maternal acute or chronic hepatitis B infection
3. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
4. Bleeding disorders and/or prolonged bleeding time
5. Major congenital defects or chronic disease
6. Premature birth (<37 weeks gestation at birth).
7. Previously received any vaccine (particularly hepatitis B)
8. Unable to obtain sufficient blood sample during >2 of the 4 blood sampling visits
Temporary Exclusion Criterion - Vaccination will be postponed until resolution of fever if axillary/aural temperature is >= 38°C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hib antibody concentrations and MenC-specific antibody titres measured one month after primary immunisation, prior to routine booster vaccination at 12 months of age
- Secondary Outcome Measures
Name Time Method ot provided at time of registration