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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
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.
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.
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.
Malindi District Hospital
Malindi, Coast, Kenya
Serotype-specific anti-pneumococcal antibody responses to vaccination
Time frame: Day 0, 30, 90, 210
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
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