Clinical Trial: PCV10 Reactogenicity and Immunogenicity Study - Malindi
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months
Brief Summary: 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.
Detailed Summary:
Sponsor: KEMRI-Wellcome Trust Collaborative Research Program
Current Primary Outcome: Serotype-specific anti-pneumococcal antibody responses to vaccination [ Time Frame: Day 0, 30, 90, 210 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Serotype-specific NP carriage of pneumococci [ Time Frame: Day 0, 30, 60, 90, 180 ]
- Vaccine reactogenicity [ Time Frame: Day 0, 3 ]
- Immunological memory responses [ Time Frame: Day 0, 30, 90, 210 ]
Original Secondary Outcome: Same as current
Information By: KEMRI-Wellcome Trust Collaborative Research Program
Dates:
Date Received: December 7, 2009
Date Started: January 2010
Date Completion: December 2016
Last Updated: December 4, 2015
Last Verified: December 2015
