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
Public ClinicalTrials.gov record NCT03765073. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03765073
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,208 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2019 (Actual)
- Primary completion
- Mar 4, 2024 (Actual)
- Completion
- Mar 4, 2024 (Actual)
- Last update posted
- Aug 5, 2025
2019 – 2024
United States locations
- U.S. sites
- 26
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research | Mobile | Alabama | 36608 | — |
| Velocity Clinical Research, Phoenix | Phoenix | Arizona | 85006 | — |
| Chemidox Clinical Trials Inc. | Lancaster | California | 93534 | — |
| Chemidox Clinical Trials Inc | Lancaster | California | 93534 | — |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Clinical Research Prime Rexburg | Rexburg | Idaho | 83440 | — |
| Lakeview Regional Medical Center | Covington | Louisiana | 70433 | — |
| MedPharmics | Covington | Louisiana | 70433 | — |
| St. Tammany Parish Hospital | Covington | Louisiana | 70433 | — |
| North Oaks Medical Center | Hammond | Louisiana | 70403 | — |
| North Oaks Obstetrics & Gynecology | Hammond | Louisiana | 70403 | — |
| Velocity Clinical Research | Slidell | Louisiana | 70458 | — |
| Boeson Research | Missoula | Montana | 59804 | — |
| Community Hospital | Missoula | Montana | 59804 | — |
| The Birth Center | Missoula | Montana | 59804 | — |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | — |
| Frontier Pediatric Care (Follow-Up Visits for Infant Participants) | Lincoln | Nebraska | 68506 | — |
| Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams) | Lincoln | Nebraska | 68510 | — |
| Be Well Clinical Studies | Lincoln | Nebraska | 68516 | — |
| Lowcountry Women's Specialists | Summerville | South Carolina | 29485 | — |
| Summerville Medical Center | Summerville | South Carolina | 29485 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Sentara Leigh Hospital | Norfolk | Virginia | 23502 | — |
| The Group for Women | Norfolk | Virginia | 23502 | — |
| Tidewater Physicians for Women | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03765073, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2025 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03765073 live on ClinicalTrials.gov.