Pneumococcal disease is a major cause of morbidity and mortality globally, with high incidence in both children and adults in the African meningitis belt. Pneumococcal conjugate vaccines (PCVs) are being introduced throughout the region and are expected to have a substantial impact on disease.
This randomized controlled trial aims to document the immunogenicity and reactogenicity of PCV13 (Prevnar 13) among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso, when administered according to various immunization schedules. In particular, the study examines two different infant schedules (6, 10, and 14 weeks vs. 6 weeks, 14 weeks, and 9 months), two toddler schedules (1 dose vs. 2 doses at a 2-month interval between 12 and 15 months of age), and one child schedule (1 dose between 2 and 4 years of age). Serotype-specific immune responses and adverse reactions to vaccine will be compared to those observed in the PCV13 licensing trials conducted by Pfizer.
Infants will be enrolled at birth at vaccination clinics and followed through 10 months of age, completing a total of 7 visits for vaccination, blood draws and nasopharyngeal swabbing. Toddlers and children will be identified and enrolled at home and followed at the Centre Muraz in Bobo-Dioulasso for vaccination and blood draws (2 or 3 visits for toddlers depending on group, 2 visits for children).
The occurrence of adverse events through home visits 1 and 3 days after each dose of vaccine will be documented. Serious adverse events (SAEs) will be identified at scheduled home or clinic visits and in case of consultation at the clinic or at the Pediatric department of the CHUSS referral hospital.
Subject enrollment will be launched in January 2013 for a period of 3 months, with subject follow-up until March 2017.