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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 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258995
The ClinicalTrials.gov registry entry for NCT04258995 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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