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

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
Prevnar13 (manufactured by Pfizer)
Sponsored by
Agence de Médecine Préventive, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity

Eligibility Criteria

undefined - 4 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CSPS Accart-Ville
  • Centre Muraz
  • CSPS Farakan
  • CSPS Guimbi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Child

Toddler 1 dose

Toddler 2 dose

Infants 2+1

Infants 3+0

Arm Description

1 dose of Prevnar13 at 2 to 4 years of age

Single dose of Prevnar13 at 12-15 months of age

2 doses of Prevnar13 2 months apart beginning at 12-15 months of age

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.

Infants receiving Prevnar13 at 6, 10 and 14 weeks

Outcomes

Primary Outcome Measures

Serotype-specific pneumococcal serum IgG
Primary outcome in other age groups is: 3 months post-dose 1 (toddlers) 1 month post-vaccination (children)

Secondary Outcome Measures

Serotype-specific pneumococcal serum OPA
Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage
Adverse events following immunization
Serotype-specific serum IgG

Full Information

First Posted
April 5, 2012
Last Updated
March 3, 2017
Sponsor
Agence de Médecine Préventive, France
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1. Study Identification

Unique Protocol Identification Number
NCT01577771
Brief Title
Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso
Acronym
PCV13-Bobo
Official Title
Immunogenicity and Reactogenicity of 13-valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers and Children in Bobo-Dioulasso, Burkina Faso: a Phase 4 Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agence de Médecine Préventive, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
663 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child
Arm Type
Active Comparator
Arm Description
1 dose of Prevnar13 at 2 to 4 years of age
Arm Title
Toddler 1 dose
Arm Type
Experimental
Arm Description
Single dose of Prevnar13 at 12-15 months of age
Arm Title
Toddler 2 dose
Arm Type
Active Comparator
Arm Description
2 doses of Prevnar13 2 months apart beginning at 12-15 months of age
Arm Title
Infants 2+1
Arm Type
Experimental
Arm Description
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.
Arm Title
Infants 3+0
Arm Type
Active Comparator
Arm Description
Infants receiving Prevnar13 at 6, 10 and 14 weeks
Intervention Type
Biological
Intervention Name(s)
Prevnar13 (manufactured by Pfizer)
Intervention Description
Prevnar13 administered IM in the antero-lateral thigh
Primary Outcome Measure Information:
Title
Serotype-specific pneumococcal serum IgG
Description
Primary outcome in other age groups is: 3 months post-dose 1 (toddlers) 1 month post-vaccination (children)
Time Frame
18 weeks for infants
Secondary Outcome Measure Information:
Title
Serotype-specific pneumococcal serum OPA
Time Frame
18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children)
Title
Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage
Time Frame
18 weeks, 9 months and 10 months (infants)
Title
Adverse events following immunization
Time Frame
1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance)
Title
Serotype-specific serum IgG
Time Frame
in infants, at 9 months and 10 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Bosco Ouedrogo, MD PhD
Organizational Affiliation
Centre Muraz
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSPS Accart-Ville
City
Bobo-Dioulasso
State/Province
Region des Hauts Bassins
Country
Burkina Faso
Facility Name
Centre Muraz
City
Bobo-Dioulasso
State/Province
Region des Hauts-Bassins
Country
Burkina Faso
Facility Name
CSPS Farakan
City
Bobo-Dioulasso
State/Province
Region des Hauts-Bassins
Country
Burkina Faso
Facility Name
CSPS Guimbi
City
Bobo-Dioulasso
State/Province
Region des Hauts-Bassins
Country
Burkina Faso

12. IPD Sharing Statement

Learn more about this trial

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

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