This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination. The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
663
Prevnar13 administered IM in the antero-lateral thigh
CSPS Accart-Ville
Bobo-Dioulasso, Region Des Hauts Bassins, Burkina Faso
Centre Muraz
Bobo-Dioulasso, Region Des Hauts-Bassins, Burkina Faso
CSPS Farakan
Bobo-Dioulasso, Region Des Hauts-Bassins, Burkina Faso
CSPS Guimbi
Bobo-Dioulasso, Region Des Hauts-Bassins, Burkina Faso
Serotype-specific pneumococcal serum IgG
Primary outcome in other age groups is: * 3 months post-dose 1 (toddlers) * 1 month post-vaccination (children)
Time frame: 18 weeks for infants
Serotype-specific pneumococcal serum OPA
Time frame: 18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children)
Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage
Time frame: 18 weeks, 9 months and 10 months (infants)
Adverse events following immunization
Time frame: 1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance)
Serotype-specific serum IgG
Time frame: in infants, at 9 months and 10 months of age
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