A phase IV, single group study to evaluate the magnitude of antibody response, its persistence and avidity maturation following meningococcal serogroup C conjugate booster vaccination in older children up to ten years after receipt of three doses in infancy and a booster in the second year of life - Nava booster
Phase 1
- Conditions
- Meningococcal Group C Disease
- Registration Number
- EUCTR2005-001638-34-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
No contraindications to vaccination as specified in the Green Book” – Immunisation Against Infectious Disease, HMSO.
Written informed consent obtained from the child and their parent or legal guardian
Child originally enrolled in the primary immunisation study and completed the booster phase in the second year of life
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
Current (to be checked prior to each vaccination):
Generalised acute systemic illness on the day of immunisation
Oral temperature >38oC on the day of immunisation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method