MedTrace Logo

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

NCT02377349 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2020-01-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 \[DTPA (BOOSTRIX)-048 PRI\] and 201334 \[DTPA (BOOSTRIX)-049 BST: 048\].

Conditions

  • Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

BIOLOGICAL

Boostrix™

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.

DRUG

Saline placebo

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-14
Primary Completion
2017-08-14
Completion
2017-10-24

Countries

  • Australia
  • Canada
  • Czechia
  • Finland
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377349 on ClinicalTrials.gov