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| ID | Type | Description | Link |
|---|---|---|---|
| WS779270 | Other Grant/Funding Number | Pfizer |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child | Active Comparator | 1 dose of Prevnar13 at 2 to 4 years of age |
|
| Toddler 1 dose | Experimental | Single dose of Prevnar13 at 12-15 months of age |
|
| Toddler 2 dose | Active Comparator | 2 doses of Prevnar13 2 months apart beginning at 12-15 months of age |
|
| Infants 2+1 | Experimental | Infants receiving Prevnar13 at 6 weeks, 14 weeks and 9 months. Note: This infant immunization schedule is used in many European countries and in South Africa and has been shown to be immunogenic and effective. However, few head-to-head comparisons of the 2+1 and 3+0 schedules have been conducted. |
|
| Infants 3+0 | Active Comparator | Infants receiving Prevnar13 at 6, 10 and 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevnar13 (manufactured by Pfizer) | Biological | Prevnar13 administered IM in the antero-lateral thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific pneumococcal serum IgG | Primary outcome in other age groups is:
| 18 weeks for infants |
| Measure | Description | 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) |
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Infants inclusion criteria
Infants exclusion criteria
Toddlers inclusion criteria
Toddlers exclusion criteria
Children inclusion criteria
Children exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Bosco Ouedrogo, MD PhD | Centre Muraz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSPS Accart-Ville | Bobo-Dioulasso | Region Des Hauts Bassins | Burkina Faso | |||
| Centre Muraz |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| 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 |
| 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 |
| D007239 | Infections |