NCT01577771

Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso

Immunogenicity and Reactogenicity of 13-valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers and Children in Bobo-Dioulasso, Burkina Faso: a Phase 4 Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 663 (actual)
• Sponsor: Agence de Médecine Préventive, France · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Prevnar13 (manufactured by Pfizer)	Prevnar13 administered IM in the antero-lateral thigh

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-04-16
• Last updated: 2017-03-06

Locations

4 sites across 1 country: Burkina Faso