Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso
PCV13-Bobo
2 other identifiers
interventional
663
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 16, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 6, 2017
March 1, 2017
1.2 years
April 5, 2012
March 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (5)
Child
ACTIVE COMPARATOR1 dose of Prevnar13 at 2 to 4 years of age
Toddler 1 dose
EXPERIMENTALSingle dose of Prevnar13 at 12-15 months of age
Toddler 2 dose
ACTIVE COMPARATOR2 doses of Prevnar13 2 months apart beginning at 12-15 months of age
Infants 2+1
EXPERIMENTALInfants 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 COMPARATORInfants receiving Prevnar13 at 6, 10 and 14 weeks
Interventions
Prevnar13 administered IM in the antero-lateral thigh
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CSPS Accart-Ville
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
Bobo-Dioulasso, Region Des Hauts-Bassins, Burkina Faso
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Bosco Ouedrogo, MD PhD
Centre Muraz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 16, 2012
Study Start
February 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 6, 2017
Record last verified: 2017-03