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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Prevnar13 (manufactured by Pfizer)


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria Child has visible signs of severe malnutrition Child has chronic or acute severe illness requiring specialized medical care Child has a blood coagulation disorder Child 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's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children (8.0 to 8.7 kg according to age) Blood draw at first vaccination visit was unsuccessful after 3 attempts Children inclusion criteria Child is 2 to 4 years 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 Children exclusion criteria Child has visible signs of severe malnutrition Child has chronic or acute severe illness requiring specialized medical care Child has a blood coagulation disorder Child 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's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children Blood draw at first vaccination visit was unsuccessful after 3 attempts

Ages Eligible for Study
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Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Child<br>1 dose of Prevnar13 at 2 to 4 years of age | Biological: Prevnar13 (manufactured by Pfizer)<br>* Prevnar13 administered IM in the antero-lateral thigh<br>|
| Experimental: Toddler 1 dose<br>Single dose of Prevnar13 at 12-15 months of age | Biological: Prevnar13 (manufactured by Pfizer)<br>* Prevnar13 administered IM in the antero-lateral thigh<br>|
| Active Comparator: Toddler 2 dose<br>2 doses of Prevnar13 2 months apart beginning at 12-15 months of age | Biological: Prevnar13 (manufactured by Pfizer)<br>* Prevnar13 administered IM in the antero-lateral thigh<br>|
| Experimental: Infants 2+1<br>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. | Biological: Prevnar13 (manufactured by Pfizer)<br>* Prevnar13 administered IM in the antero-lateral thigh<br>|
| Active Comparator: Infants 3+0<br>Infants receiving Prevnar13 at 6, 10 and 14 weeks | Biological: Prevnar13 (manufactured by Pfizer)<br>* Prevnar13 administered IM in the antero-lateral thigh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific pneumococcal serum IgG | Primary outcome in other age groups is: 3 months post-dose 1 (toddlers) 1 month post-vaccination (children) | 18 weeks for infants | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity