Alternative vaccination schedules with pneumococcal polysaccharide/protein conjugate vaccine: immunogenicity of the prime-booster approach among Gambian infants
Completed
- Conditions
- Pneumococcus/vaccinesInfections and InfestationsVaccination
- Registration Number
- ISRCTN50377687
- Lead Sponsor
- Medical Research Council Laboratories (The Gambia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 675
Inclusion Criteria
Babies will be recruited when they present for first dose of Diphtheria, Pertussis, Tetanus (DPT)-Haemophilus influenzae type b (Hib) vaccine and written informed consent obtained at that time
Exclusion Criteria
1. Babies born to known human immunodeficiency virus (HIV) positive mothers
2. Those with neurological abnormality
3. No parental consent
4. Established pneumococcal disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Immunogenicity of 7-valent pneumococcal conjugate vaccine at ages 18 weeks and 11 months after one, two and three doses of conjugate vaccines, measuring for antibody concentrations greater than or equal to 0.35 ug/ml<br>2. Secondary immune response (antibody) to pnuemococcal polysaccharide vaccine at age 11 months after one, two or three doses of 7-valent conjugate vaccine (antibody concentrations greater than or equal to 0.35 ug/ml)
- Secondary Outcome Measures
Name Time Method 1. Persistence of antibody at age 15 months of age<br>2. Evidence of memory response following Conjugate vaccines using assays of antibody avidity and affinity <br>3. Naso-pharyngeal carriage of vaccine and non-vaccine serotypes at ages 18 weeks, 11 and 15 months of age<br>4. Monitoring for safety and local reaction up to 15 months of age. Two main aspects of the safety surveillance will be analysed:<br>4.1. Serious Adverse Events (SAE) <br>4.2. Local and Systemic reactions<br><br>Antibody concentrations to serotypes covered by the 7-valent conjugate vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) as well as antibody concentration to selected serotypes covered by the polysaccharide vaccine (1, 3, 5 and 12) will be measured.