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

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