Immunogenicity of a Single Dose of GSK Biologicals' Boostrix™ in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia
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|ClinicalTrials.gov Identifier: NCT03188458|
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Acellular Pertussis Tetanus||Other: Blood sample||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity of a Single Dose of GSK Biologicals' Diphtheria, Tetanus and Acellular Pertussis (dTpa) Booster Vaccine (Boostrix™ ) in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2019|
Second and third trimester Group
This study group will include infants whose mothers have received Boostrix during the second (21-27 weeks) and third trimester (above 28 weeks) of their pregnancy, as per routine practice.
Other: Blood sample
Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 [approximately 4-8 weeks of age]).
- Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN). [ Time Frame: For cord blood sample - Visit 1 (Day 0). For blood samples collected from infants prior to their first routine primary pertussis vaccination - Visit 2 (at approximately 4-8 weeks of age of subjects). ]Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
- Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN. [ Time Frame: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56). ]Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
- Anti-PT, anti-FHA and anti-PRN antibody concentrations. [ Time Frame: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56). ]Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188458
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|GSK Investigational Site||Recruiting|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|