NCT01028326

PCV10 Reactogenicity and Immunogenicity Study - Malindi

Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: KEMRI-Wellcome Trust Collaborative Research Program · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	PCV10 and DTaP	A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.
BIOLOGICAL	PCV10 and DTaP	A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 180 and a 0.5 mL dose of DTaP on day 60.
BIOLOGICAL	hepatitis A vaccine, DTaP, PCV10	A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2018-12-01
• First posted: 2009-12-09
• Last updated: 2018-02-23

Locations

1 site across 1 country: Kenya