Trials / Completed
CompletedNCT02377349
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women
Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 688 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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 \[DTPA (BOOSTRIX)-049 BST: 048\].
Detailed description
The protocol was amended to include Spain in the study. The reasons for the Spain-specific amendment are listed below: * Based on the feedback from the Spanish Ethics Committee, the evaluation related to the acceptance of cocooning was added in the protocol. * The objectives and endpoints to include cocooning were added in the protocol. * The eligibility criteria for participation of household contacts were defined in the protocol. * The study procedures for household contacts were included.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-10-14
- Primary completion
- 2017-08-14
- Completion
- 2017-10-24
- First posted
- 2015-03-03
- Last updated
- 2020-01-28
- Results posted
- 2019-01-28
Locations
35 sites across 6 countries: Australia, Canada, Czechia, Finland, Italy, Spain
Source: ClinicalTrials.gov record NCT02377349. Inclusion in this directory is not an endorsement.