Pneumococcal Infections
Conditions
Keywords
Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity
Brief 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).
Interventions
BIOLOGICALPrevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Sponsors
Agence de Médecine Préventive, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Years
Healthy volunteers
Yes
Inclusion criteria
Infants inclusion criteria * Child has birth weight ≥ 2500g * Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant * Mother has resided in Burkina Faso for at least 2 years * Mother has African nationality * Child will reside in Bobo-Dioulasso urban area for the duration of the study * Parent or guardian has given informed consent for child's participation Infants
Exclusion criteria
* Child was born with a congenital abnormality * Child has chronic or acute severe illness requiring specialized medical care * Child has a blood coagulation disorder * Mother has known HIV infection * Child is enrolled in another clinical trial * Child has known allergy to a component of the vaccine * Child received a pneumococcal vaccine outside the context of the trial * Child is 53 days of age or older at 6 week visit * Child weighs \<3500g at the 6 week visit * Blood draw at 6 week visit was unsuccessful after 3 attempts Toddlers inclusion criteria * Child is 12 to 15 months of age * Child has resided in Burkina Faso since birth * Child has African nationality * Child will reside in Bobo-Dioulasso urban area for the duration of the study * Parent or guardian has given informed consent for child's participation Toddlers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific pneumococcal serum IgG | 18 weeks for infants | Primary outcome in other age groups is: * 3 months post-dose 1 (toddlers) * 1 month post-vaccination (children) |
Secondary
| Measure | Time frame |
|---|---|
| Serotype-specific pneumococcal serum OPA | 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 | 18 weeks, 9 months and 10 months (infants) |
| Adverse events following immunization | 1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance) |
| Serotype-specific serum IgG | in infants, at 9 months and 10 months of age |
Countries
Burkina Faso
Outcome results
None listed