Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso (PCV13-Bobo)

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

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).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: Prevnar13 (manufactured by Pfizer)

• Study Type: Interventional
• Enrollment (Actual): 663
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burkina Faso
  • Region des Hauts Bassins
    • Bobo-Dioulasso, Region des Hauts Bassins, Burkina Faso
      • CSPS Accart-Ville
  • Region des Hauts-Bassins
    • Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
      • Centre Muraz
    • Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
      • CSPS Farakan
    • Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
      • CSPS Guimbi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Agence de Médecine Préventive, France
• Investigators: Principal Investigator: Jean-Bosco Ouedrogo, MD PhD, Centre Muraz

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Immunogenicity; Reactogenicity; Pneumococcal conjugate vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PCV13-Immunogenicity-Bobo; WS779270 (Other Grant/Funding Number: Pfizer)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No