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

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

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.

Study Overview

• Status: Terminated
• Conditions: Diphtheria-Tetanus-Acellular Pertussis
• Intervention / Treatment: Other: Blood sample

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
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
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.	At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Infants; Boostrix; Acellular pertussis; Pregnant women; Colombia; Cord blood sample
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria
• Other Study ID Numbers: 201522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No