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

NCT03188458 | Terminated Phase 4

• 1 other identifier: 201522
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria-Tetanus-Acellular Pertussis

Keywords

Infants; Cord blood sample; Acellular pertussis; Boostrix; Colombia; Pregnant women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.

  At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).

• Anti-PT, anti-FHA and anti-PRN antibody concentrations.

  At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).

Study Arms (1)

Second and third trimester Group

OTHER

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

Interventions

Blood sample OTHER

Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 \[approximately 4-8 weeks of age\]).

Second and third trimester Group

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bogotá, Colombia

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: June 15, 2017
• Study Start: May 29, 2018
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)