Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Phase 4
Completed
- Conditions
- Pneumococcal InfectionsMeningococcal Infections
- Interventions
- Biological: menjugateBiological: Men C ConjugateBiological: Men C conjugate vaccine
- Registration Number
- NCT00197808
- Lead Sponsor
- Public Health England
- Brief Summary
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
Inclusion Criteria
- Written informed consent obtained from parent or legal guardian of infant
- Age 7-11 weeks at first dose
Exclusion Criteria
- Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
- < 7 weeks or > 11 weeks at first dose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaccine schedule 1 menjugate Menjugate vaccine at 2 and 3 months Vaccine schedule 6 Men C Conjugate Meningitec at 2 and 4 months Vaccine schedule 2 Men C conjugate vaccine Menjugate vaccine at 2 and 4 months vaccine schedule 4 Men C Conjugate Neissvacc at 2 and 4 months Vaccine schedule 5 Men C Conjugate Meningitec at 2 and 3 months vaccine schedule3 Men C Conjugate Neissvacc at 2 and 3 months
- Primary Outcome Measures
Name Time Method Immunogenicity 3 months after last sample SBA men C responses
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Gloucestershire Primary Care Trusts
🇬🇧Gloucester, United Kingdom
Hertfordshire Primary Care Trusts
🇬🇧Welwyn Garden City, Hertfordshire, United Kingdom