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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 4

Conditions: Diphtheria-Tetanus-Acellular Pertussis

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT03188458

201522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: Under 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Second and third trimester Group

Other group

Description:

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.

Treatment:

Other: Blood sample