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NCT02270944 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,053
- Enrollment target
NCT02270944: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02270944 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,053 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (692% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270944, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Primary Outcome
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Interventions
- BIOLOGICAL GBS Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2014-11-20 |
| Est. Completion | 2015-09-22 |
| Phase | Phase 2 |
What the finished NCT02270944 record still lists
NCT02270944 is an interventional study that assigns participants to a tested intervention. Its 1,053 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (692% higher).
The record links to 0 conditions, and to 1 intervention - of which GBS Vaccine is the first listed.
NCT02270944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02270944 about?
NCT02270944 is a clinical study titled "Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine". The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulat...
What is the current status of trial NCT02270944?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,053 participants. The study started on 2014-11-20. Estimated completion is 2015-09-22.
What interventions are being tested in trial NCT02270944?
The interventions under investigation include: GBS Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02270944?
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 NCT02270944's enrollment target sits among peer trials
1,053 24th of 2000 higher than 1,977 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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