NCT03188458

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria-Tetanus-Acellular Pertussis

Interventions

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

Timeline

• Start date: 2018-05-29
• Primary completion: 2018-10-22
• Completion: 2018-10-22
• First posted: 2017-06-15
• Last updated: 2019-02-12

Locations

1 site across 1 country: Colombia