Phase III, double-blind, randomised, placebo-controlled trial to evaluate efficacy against radiological pneumonia and invasive pneumococcal disease in Gambian infants
Completed
- Conditions
- Pneumococcus/vaccinesInfections and InfestationsVaccination
- Registration Number
- ISRCTN46147225
- Lead Sponsor
- ational Institute of Allergy and Infectious Diseases - Division of Microbiology and Infectious Diseases (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17500
Inclusion Criteria
1. Infants aged at least 6 weeks and less than one year
2. Resident in study area
3. Written informed consent obtained from mother
Exclusion Criteria
1. Aged less than 6 weeks or more than 1 year
2. Not resident in study area
3. Planning to move out of study area within 4 months
4. Previous receipt of Diphtheria, Pertussis, Tetanus (DPT)-Haemophilus influenzae type b (Hib) vaccine
5. Uncertain prior vaccination record
6. Serious chronic illness
7. Inclusion in previous vaccine trial
8. Failure of family to give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First episode of radiological pneumonia
- Secondary Outcome Measures
Name Time Method 1. Clinical or severe clinical pneumonia<br>2. Invasive pneumococcal disease<br>3. All-cause admissions