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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02046148 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
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 |
What the finished NCT02046148 record still lists
NCT02046148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02046148 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02046148's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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