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NCT04258995 · ClinicalTrials.gov registry record · Phase 2
A Trial TO Evaluate THE Safety, Tolerability, AND Immunogenicity OF A Booster Dose OF A Group B Streptococcus 6 Valent Polysaccharide Conjugate Vaccine (GBS6) IN Healthy Adults
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT04258995: Completed Phase 2 study, sponsored by Pfizer.
NCT04258995 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258995, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.
Primary Outcome
Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter \[cm\]), moderate (greater than \[
Interventions
- BIOLOGICAL Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2020-09-15 |
| Phase | Phase 2 |
What the finished NCT04258995 record still lists
NCT04258995 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) is the first listed.
NCT04258995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258995 about?
NCT04258995 is a clinical study titled "A Trial TO Evaluate THE Safety, Tolerability, AND Immunogenicity OF A Booster Dose OF A Group B Streptococcus 6 Valent Polysaccharide Conjugate Vaccine (GBS6) IN Healthy Adults". This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The s...
What is the current status of trial NCT04258995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2020-02-11. Estimated completion is 2020-09-15.
What interventions are being tested in trial NCT04258995?
The interventions under investigation include: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04258995?
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 NCT04258995's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 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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