Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03188458
Status:
TERMINATED
Last Update Posted:
2019-02-12
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As similar local evidence recently available, present study will not add new information; no ethical justification exists to continue study procedures.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: