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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2018-10-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diphtheria-Tetanus-Acellular Pertussis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Blood sample

Intervention Type OTHER

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

Interventions

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Blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes