Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso
NCT ID: NCT01577771
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
663 participants
INTERVENTIONAL
2013-02-28
2014-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Child
1 dose of Prevnar13 at 2 to 4 years of age
Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Toddler 1 dose
Single dose of Prevnar13 at 12-15 months of age
Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Toddler 2 dose
2 doses of Prevnar13 2 months apart beginning at 12-15 months of age
Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
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.
Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Infants 3+0
Infants receiving Prevnar13 at 6, 10 and 14 weeks
Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Interventions
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Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
Exclusion Criteria
* 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 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
* 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
4 Years
ALL
Yes
Sponsors
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Agence de Médecine Préventive, France
OTHER
Responsible Party
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Principal Investigators
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Jean-Bosco Ouedrogo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Muraz
Locations
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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
Countries
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Other Identifiers
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WS779270
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PCV13-Immunogenicity-Bobo
Identifier Type: -
Identifier Source: org_study_id
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