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
Completed · Phase 2 · Has a placebo group
Conditions studied: Group B Streptococcus Infections
In brief
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.
Key facts
- Study ID
- NCT03765073
- Run by
- Pfizer
- People needed
- 1208
- Starts
- 2019-01-14
- Expected to finish
- 2024-03-04
- Last updated by the study team
- 2025-08-05
Who can join
Age: any, up to 40. Sex: any. Healthy volunteers: accepted.
Where it is running
- Velocity Clinical Research — Mobile, Alabama, United States
- Velocity Clinical Research, Phoenix — Phoenix, Arizona, United States
- Chemidox Clinical Trials Inc. — Lancaster, California, United States
- Chemidox Clinical Trials Inc — Lancaster, California, United States
- Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
- Clinical Research Prime — Idaho Falls, Idaho, United States
- Clinical Research Prime Rexburg — Rexburg, Idaho, United States
- Lakeview Regional Medical Center — Covington, Louisiana, United States
- MedPharmics — Covington, Louisiana, United States
- St. Tammany Parish Hospital — Covington, Louisiana, United States
- North Oaks Medical Center — Hammond, Louisiana, United States
- North Oaks Obstetrics & Gynecology — Hammond, Louisiana, United States
- Velocity Clinical Research — Slidell, Louisiana, United States
- Boeson Research — Missoula, Montana, United States
- Community Hospital — Missoula, Montana, United States
- The Birth Center — Missoula, Montana, United States
- Meridian Clinical Research — Hastings, Nebraska, United States
- Frontier Pediatric Care (Follow-Up Visits for Infant Participants) — Lincoln, Nebraska, United States
- Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams) — Lincoln, Nebraska, United States
- Be Well Clinical Studies — Lincoln, Nebraska, United States
- Lowcountry Women's Specialists — Summerville, South Carolina, United States
- Summerville Medical Center — Summerville, South Carolina, United States
- Coastal Pediatric Research — Summerville, South Carolina, United States
- Sentara Leigh Hospital — Norfolk, Virginia, United States
- The Group for Women — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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