Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Public Health England
- Enrollment
- 392
- Locations
- 2
- Primary Endpoint
- Immunogenicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Weeks to 11 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Vaccine schedule 2
Menjugate vaccine at 2 and 4 months
Intervention: Men C conjugate vaccine (Biological)
vaccine schedule3
Neissvacc at 2 and 3 months
Intervention: Men C conjugate (Biological)
vaccine schedule 4
Neissvacc at 2 and 4 months
Intervention: Men C Conjugate (Biological)
Vaccine schedule 5
Meningitec at 2 and 3 months
Intervention: Men C conjugate (Biological)
Vaccine schedule 6
Meningitec at 2 and 4 months
Intervention: Men C conjugate (Biological)
Vaccine schedule 1
Menjugate vaccine at 2 and 3 months
Intervention: menjugate (Biological)
Outcomes
Primary Outcomes
Immunogenicity
Time Frame: 3 months after last sample
SBA men C responses
Secondary Outcomes
No secondary outcomes reported