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

Phase 4

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: Prevnar13 (manufactured by Pfizer)

• Registration Number: NCT01577771
• Lead Sponsor: Agence de Médecine Préventive, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Study Start: 2013-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 663

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child	Prevnar13 (manufactured by Pfizer)	1 dose of Prevnar13 at 2 to 4 years of age
Infants 2+1	Prevnar13 (manufactured by Pfizer)	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.
Toddler 1 dose	Prevnar13 (manufactured by Pfizer)	Single dose of Prevnar13 at 12-15 months of age
Toddler 2 dose	Prevnar13 (manufactured by Pfizer)	2 doses of Prevnar13 2 months apart beginning at 12-15 months of age
Infants 3+0	Prevnar13 (manufactured by Pfizer)	Infants receiving Prevnar13 at 6, 10 and 14 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

CSPS Accart-Ville; 🇧🇫 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

Centre Muraz; 🇧🇫 Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso