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NCT03765073 · ClinicalTrials.gov registry record · Phase 2
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,208
- Enrollment target
NCT03765073: Completed Phase 2 study, sponsored by Pfizer.
NCT03765073 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 1,208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (808% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03765073, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,208 participants
- Enrollment target
Study Summary
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
Primary Outcome
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection sit
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Multivalent Group B streptococcus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,208 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2024-03-04 |
| Phase | Phase 2 |
What the finished NCT03765073 record still lists
NCT03765073 is an interventional study that assigns participants to a tested intervention. Its 1,208 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 (808% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03765073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03765073 about?
NCT03765073 is a clinical study titled "Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants". Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one...
What is the current status of trial NCT03765073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,208 participants. The study started on 2019-01-14. Estimated completion is 2024-03-04.
What interventions are being tested in trial NCT03765073?
The interventions under investigation include: Placebo (BIOLOGICAL), Multivalent Group B streptococcus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03765073?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03765073's enrollment target sits among peer trials
1,208 17th of 2000 higher than 1,984 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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