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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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Diphtheria Acellular Pertussis Tetanus Other: Blood sample Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019


Arm Intervention/treatment
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]).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Colombia
GSK Investigational Site Recruiting
Bogotá, Colombia
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   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03188458     History of Changes
Other Study ID Numbers: 201522
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Infants
Cord blood sample
Acellular pertussis
Boostrix
Colombia
Pregnant women

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs