Back to resultsImmunogenicity 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
Primary Purpose
Diphtheria-Tetanus-Acellular Pertussis
Status
Terminated
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria-Tetanus-Acellular Pertussis focused on measuring Infants, Cord blood sample, Acellular pertussis, Boostrix, Colombia, Pregnant women
Eligibility Criteria
Inclusion Criteria:
Criteria applicable at screening (before the birth of the infant):
- Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
- Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from both parents of the infant.
Criteria applicable at enrolment (after the birth of the infant):
- Confirmation of written informed consent obtained from both parents of the infant at the time of screening.
- Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion Criteria:
Criteria applicable at screening (before the birth of the infant):
- Infants whose parents are below the legal consenting age of the country.
- Infant's whose mother has multiple pregnancies.
- Infant's whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
- Infant's whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant's mother has been or will be exposed to an investigational or a non-investigational vaccine/product.
Criteria applicable at enrolment (after the birth of the infant):
- Child in care.
- In case of multiple births.
- Infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result.
- Infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Second and third trimester Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Secondary Outcome Measures
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
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.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03188458
Brief Title
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
Official Title
Immunogenicity of a Single Dose of GSK Biologicals' Diphtheria, Tetanus and Acellular Pertussis (dTpa) Booster Vaccine (Boostrix™ [263855]) in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
As similar local evidence recently available, present study will not add new information; no ethical justification exists to continue study procedures.
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to support the recommendation of vaccination of all pregnant women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of pertussis specific IgG antibodies from mother to the child.
Detailed Description
This study will assess the immunogenicity in infants (at birth and just prior to primary pertussis vaccination [i.e. diphtheria, tetanus and pertussis [DTP] vaccination] administered at 8 weeks of age), of a single Boostrix booster dose administered to their mothers during the second or third trimester as per routine practice in Bogota, Colombia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria-Tetanus-Acellular Pertussis
Keywords
Infants, Cord blood sample, Acellular pertussis, Boostrix, Colombia, Pregnant women
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Second and third trimester Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 [approximately 4-8 weeks of age]).
Primary Outcome Measure Information:
Title
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
Description
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
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).
Secondary Outcome Measure Information:
Title
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
Description
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame
At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
Title
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Description
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
Time Frame
At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Criteria applicable at screening (before the birth of the infant):
Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from both parents of the infant.
Criteria applicable at enrolment (after the birth of the infant):
Confirmation of written informed consent obtained from both parents of the infant at the time of screening.
Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion Criteria:
Criteria applicable at screening (before the birth of the infant):
Infants whose parents are below the legal consenting age of the country.
Infant's whose mother has multiple pregnancies.
Infant's whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
Infant's whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant's mother has been or will be exposed to an investigational or a non-investigational vaccine/product.
Criteria applicable at enrolment (after the birth of the infant):
Child in care.
In case of multiple births.
Infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result.
Infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bogotá
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Learn more about this trial
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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