ClinicalTrials.gov record
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
ClinicalTrials.gov ID: NCT04032093
Public ClinicalTrials.gov record NCT04032093. 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 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Study identification
- NCT ID
- NCT04032093
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- Female
- 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
- Aug 6, 2019
- Primary completion
- Sep 29, 2021
- Completion
- Sep 29, 2021
- Last update posted
- Oct 17, 2022
2019 – 2021
United States locations
- U.S. sites
- 145
- U.S. states
- 23
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| UAB Women & Infants Center - UAB Medicine | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Cullman Clinical Research, Inc | Cullman | Alabama | 35058 | — |
| Cullman Primary Care, PC | Cullman | Alabama | 35058 | — |
| Cullman Regional | Cullman | Alabama | 35058 | — |
| Arrowhead Hospital | Glendale | Arizona | 85308 | — |
| Abrazo West Campus Hospital | Goodyear | Arizona | 85395 | — |
| St. Joseph Hospital | Phoenix | Arizona | 85013 | — |
| MedPharmics, LLC | Phoenix | Arizona | 85015 | — |
| Mesquite Pediatrics | Tucson | Arizona | 85712 | — |
| Watching Over Mothers and Babies | Tucson | Arizona | 85712 | — |
| Join Clinical Trials | Bellflower | California | 90706 | — |
| Chowchilla Hospital Clinic | Chowchilla | California | 93610 | — |
| Join Clinical Trials | Huntington Park | California | 90255 | — |
| Matrix Clinical Research | Huntington Park | California | 90255 | — |
| Join Clinical Trials | Los Angeles | California | 90006 | — |
| East Los Angeles Doctors Hospital | Los Angeles | California | 90023 | — |
| White Memorial Medical Center | Los Angeles | California | 90033 | — |
| Join Clinical Trials | Los Angeles | California | 90036 | — |
| Matrix Clinical Research | Los Angeles | California | 90057 | — |
| Affiliated Physician Practice | Madera | California | 93637 | — |
| Charles E. Ugwu-Oju, MD, FACOG | Madera | California | 93637 | — |
| Madera Community Hospital | Madera | California | 93637 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Monterey Park Hospital | Monterey Park | California | 91754 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| University of Colorado Anschutz Inpatient Pavilion 2 | Aurora | Colorado | 80045 | — |
| University of Colorado AO1 | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital Inpatient Pavilion | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital Outpatient Pavilion | Aurora | Colorado | 80045 | — |
| University of Colorado Leprino Building | Aurora | Colorado | 80045 | — |
| University of Colorado Research II Building | Aurora | Colorado | 80045 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | — |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | — |
| Grove Creek Medical Center | Blackfoot | Idaho | 83221 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Eastern Idaho Regional Medical Center | Idaho Falls | Idaho | 83404 | — |
| Family First Medical Center | Idaho Falls | Idaho | 83404 | — |
| Mountain View Hospital | Idaho Falls | Idaho | 83404 | — |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | — |
| The Pediatric Center | Idaho Falls | Idaho | 83404 | — |
| Saltzer Medical Group | Nampa | Idaho | 83686 | — |
| ASR, LLC | Nampa | Idaho | 83687 | — |
| Saltzer Medical Group | Nampa | Idaho | 83687 | — |
| Pocatello Women's Health Clinic | Pocatello | Idaho | 83201 | — |
| Portneuf Medical Center | Pocatello | Idaho | 83201 | — |
| The Pediatric Center | Rigby | Idaho | 83442 | — |
| The Iowa Clinic | Ankeny | Iowa | 50023 | — |
| Methodist West Hospital | West Des Moines | Iowa | 50266 | — |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| Alliance for Multispecialty Research, LLC | El Dorado | Kansas | 67042 | — |
| Hutchinson Clinic, P.A. | Hutchinson | Kansas | 67502 | — |
| Hutchinson Regional Medical Center | Hutchinson | Kansas | 67502 | — |
| Cambridge Medical Trials | Alexandria | Louisiana | 71301 | — |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | — |
| Allina Health Blaine Clinic | Blaine | Minnesota | 55449 | — |
| Allina Health Coon Rapids Clinic | Coon Rapids | Minnesota | 55433 | — |
| Allina Health Mercy Women's Clinic | Coon Rapids | Minnesota | 55433 | — |
| Mercy Hospital (Allina Health) | Coon Rapids | Minnesota | 55433 | — |
| The Mother Baby Center at Mercy with Children's (Allina Health) | Coon Rapids | Minnesota | 55433 | — |
| Allina Health Fridley Clinic | Fridley | Minnesota | 55432 | — |
| Infectious Disease Research | Minneapolis | Minnesota | 55404 | — |
| Abbott Northwestern Hospital (Allina Health) | Minneapolis | Minnesota | 55407 | — |
| Oshsner Medical Center - Hancock | Bay Saint Louis | Mississippi | 39520 | — |
| Merit Health Biloxi | Biloxi | Mississippi | 39530 | — |
| Gulfport Memorial Hospital | Gulfport | Mississippi | 39501 | — |
| Gulfport OB-GYN | Gulfport | Mississippi | 39503 | — |
| MedPharmics, LLC | Gulfport | Mississippi | 39503 | — |
| Singing River Health System | Gulfport | Mississippi | 39503 | — |
| St Lukes Hospital | Chesterfield | Missouri | 63017 | — |
| Baer Pediatrics | St Louis | Missouri | 63131 | — |
| KDB Enterprises | St Louis | Missouri | 63141 | — |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Boeson Research | Great Falls | Montana | 59405 | — |
| Boeson Research | Missoula | Montana | 59804 | — |
| Bryan Health | Lincoln | Nebraska | 68506 | — |
| Bryan Women's Care Physicians | Lincoln | Nebraska | 68510 | — |
| Midwest Childrens Health Research Institute | Lincoln | Nebraska | 68516 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| MedPharmics | Albuquerque | New Mexico | 87102 | — |
| Winthrop Women's Wellness | Hempstead | New York | 11550 | — |
| Sante Comprehensive Women's Healthcare | Johnson City | New York | 13790 | — |
| NYU Winthrop Hospital, Research Pharmacy | Mineola | New York | 11501 | — |
| NYU Winthrop Hospital | Mineola | New York | 11501 | — |
| NYU Winthrop Pediatric Infectious Diseases | Mineola | New York | 11501 | — |
| Women's Contemporary Care Associates | Mineola | New York | 11501 | — |
| University of Rochester Obstetrics and Gynecology | Rochester | New York | 14620 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Duke Children's Primary Care - Roxboro Street | Durham | North Carolina | 27704 | — |
| Duke Regional Hospital | Durham | North Carolina | 27704 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Duke University Hospital | Durham | North Carolina | 27710 | — |
| Sugarcamp Family Practice | Dayton | Ohio | 45409 | — |
| Needmore Medical Center | Dayton | Ohio | 45414 | — |
| Kettering Medical Center | Dayton | Ohio | 45429 | — |
| HWC Women's Center Research | Englewood | Ohio | 45322 | — |
| Lowcountry Womens Specialists | Summerville | South Carolina | 29485 | — |
| Summerville Medical Center | Summerville | South Carolina | 29485 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Center for Women''s Health and Birthcare | Beaumont | Texas | 77702 | — |
| CHRISTUS St. Elizabeth Hospital | Beaumont | Texas | 77702 | — |
| Gadolin Research, LLC | Beaumont | Texas | 77702 | — |
| Pediatric Clinic of Dr. Alvin H. Prause | Beaumont | Texas | 77702 | — |
| Texas Health Harris Methodist Hurst-Euless-Bedford Hospital | Bedford | Texas | 76022 | — |
| Texas Health Huguley Hospital South | Burleson | Texas | 76028 | — |
| 8th Avenue Obstetrics and Gynecology | Fort Worth | Texas | 76104 | — |
| Baylor Scott & White of Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Health Harris Methodist Hospital FTW | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | — |
| Texas Health Harris Methodist Hospital Southwest | Fort Worth | Texas | 76132 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Chisholm Trail Pediatrics | Georgetown | Texas | 78626 | — |
| FMC Science, LLC | Georgetown | Texas | 78626 | — |
| Georgetown OBGYN | Georgetown | Texas | 78626 | — |
| St. David's Georgetown Hospital | Georgetown | Texas | 78626 | — |
| Baylor Scott & White of Grapevine (Hospital) | Grapevine | Texas | 76051 | — |
| Dr Van Tran Family Practice | Houston | Texas | 77008 | — |
| HG Pediatrics | Houston | Texas | 77008 | — |
| Memorial Herman Greater Heights Hospital | Houston | Texas | 77008 | — |
| Ventavia Research Group, LLC | Houston | Texas | 77008 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | — |
| AdventHealth Family Medicine Rural Health Clinic, Inc. | Lampasas | Texas | 76550 | — |
| FMC Science | Lampasas | Texas | 76550 | — |
| DCOL Center For Clinical Research | Longview | Texas | 75605 | — |
| Diagnostic Clinic of Longview | Longview | Texas | 75605 | — |
| Longview Regional Medical Center | Longview | Texas | 75605 | — |
| Dr. Ruben Aleman and Associates | McAllen | Texas | 78504 | — |
| Exygon Clinical Research | Pharr | Texas | 78577 | — |
| Texas Health Presbyterian Hospital | Plano | Texas | 75093 | — |
| Ventavia Research Group LLC | Plano | Texas | 75093 | — |
| Ascension Seton Williamson | Round Rock | Texas | 78665 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | — |
| Old Farm Obstetrics & Gynecology, LLC | Salt Lake City | Utah | 84107 | — |
| St. Marks Hospital | Salt Lake City | Utah | 84124 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23235 | — |
| Johnston Willis Hospital | Richmond | Virginia | 23235 | — |
| Cabell Huntington Hospital | Huntington | West Virginia | 25701 | — |
| Marshall Health dba University Pediatrics | Huntington | West Virginia | 25701 | — |
| Marshall Health Department of Obstetrics and Gynecology | Huntington | West Virginia | 25701 | — |
| Translational Genomic Research Institute | Huntington | West Virginia | 25701 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04032093, 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 Oct 17, 2022 · Synced Sep 8, 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 protocol, eligibility criteria, and contact information for NCT04032093 live on ClinicalTrials.gov.