ISRCTN15056916
Active, not recruiting
Phase 4
A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine in rural Gambia.
ondon School of Hygiene & Tropical Medicine0 sites50,000 target enrollmentNovember 15, 2018
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Streptococcus pneumoniae disease and pneumococcal colonisation
- Sponsor
- ondon School of Hygiene & Tropical Medicine
- Enrollment
- 50000
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2022 Protocol article in https://doi.org/10.1186/s13063-021-05964-5 (added 24/05/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Resident in the study area
- •2\. Children aged 6 weeks to 365 days will be eligible to receive the intervention
- •3\. Children aged 2 weeks to 59 months will be eligible for measurement of the primary endpoint and disease endpoints by disease surveillance
Exclusion Criteria
- •1\. Intent to move out of the study area before 4 months of age
- •2\. Aged over 364 days
- •3\. Contraindication to vaccination with PCV13, including severe hypersensitivity to a previous dose of PCV13
Outcomes
Primary Outcomes
Not specified
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