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Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months (PRISM)
The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.
Details
| Lead sponsor | KEMRI-Wellcome Trust Collaborative Research Program |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 600 |
| Start date | 2010-01 |
| Completion | 2018-12 |
Conditions
- Pneumococcal Pneumonia
Interventions
- PCV10 and DTaP
- PCV10 and DTaP
- hepatitis A vaccine, DTaP, PCV10
Primary outcomes
- Serotype-specific anti-pneumococcal antibody responses to vaccination — Day 0, 30, 90, 210
Countries
Kenya