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

Phase 4

Terminated

• Conditions: Diphtheria-Tetanus-Acellular Pertussis
• Interventions: Other: Blood sample

• Registration Number: NCT03188458
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2018-05-29
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Second and third trimester Group	Blood sample	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.

Primary Outcome Measures

Name	Time	Method
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).	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

Name	Time	Method
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).	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.	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇴 Bogotá, Colombia