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NCT02046148 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT02046148 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants.
The verdict
NCT02046148, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GBS trivalent vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-03-18 |
| Est. Completion | 2016-03-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046148
The ClinicalTrials.gov registry entry for NCT02046148 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02046148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02046148 about?
NCT02046148 is a clinical study titled "Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women". Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast mil...
What is the current status of trial NCT02046148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2014-03-18. Estimated completion is 2016-03-26.
What interventions are being tested in trial NCT02046148?
The interventions under investigation include: Placebo (BIOLOGICAL), GBS trivalent vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02046148?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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