V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Public ClinicalTrials.gov record NCT03486834. 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
Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.
Study identification
- NCT ID
- NCT03486834
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 35 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
- Apr 30, 2018 (Actual)
- Primary completion
- Oct 30, 2020 (Actual)
- Completion
- Jun 30, 2021 (Actual)
- Last update posted
- Jan 23, 2024
2018 – 2021
United States locations
- U.S. sites
- 54
- U.S. states
- 19
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics ( Site 0025) | Birmingham | Alabama | 35205 | — |
| Achieve Clinical Research, LLC ( Site 0055) | Birmingham | Alabama | 35216 | — |
| Synexus US Phoenix Southeast ( Site 0057) | Chandler | Arizona | 85224 | — |
| Inland Empire Liver Foundation ( Site 0026) | Rialto | California | 92377 | — |
| Integrated Research of Inland, Inc. ( Site 0042) | Riverside | California | 92506 | — |
| California Research Foundation ( Site 0286) | San Diego | California | 92123 | — |
| Bayview Research Group, LLC ( Site 0012) | Valley Village | California | 91607 | — |
| Diablo Clinical Research, Inc ( Site 0009) | Walnut Creek | California | 94598 | — |
| Emerson Clinical Research Institute ( Site 0297) | Washington D.C. | District of Columbia | 20011 | — |
| Clinical Research of South Florida ( Site 0047) | Coral Gables | Florida | 33134 | — |
| Indago Research & Health Center, Inc ( Site 0007) | Hialeah | Florida | 33012 | — |
| NF Research Center LLC ( Site 0013) | Hialeah | Florida | 33012 | — |
| Best Quality Research Inc. ( Site 0031) | Hialeah | Florida | 33016 | — |
| Care Partners Clinical Research, LLC ( Site 0002) | Jacksonville | Florida | 32277 | — |
| L&C Professional Medical Research Institute ( Site 0021) | Miami | Florida | 33144 | — |
| Advanced Medical Research Institute ( Site 0296) | Miami | Florida | 33174 | — |
| Kendall South Medical Center, Inc ( Site 0008) | Miami | Florida | 33185 | — |
| New Age Medical Research Corporation ( Site 0018) | Miami | Florida | 33186 | — |
| Clinical Associates of Orlando, LLC ( Site 0032) | Orlando | Florida | 32806 | — |
| Columbus Regional Research Institute ( Site 0298) | Columbus | Georgia | 31904 | — |
| Heartland Research Associates, LLC ( Site 0044) | Augusta | Kansas | 67010 | — |
| Heartland Research Associates, LLC ( Site 0023) | Newton | Kansas | 67114 | — |
| Heartland Research Associates, LLC ( Site 0019) | Wichita | Kansas | 67205 | — |
| ACC Pediatric Research ( Site 0022) | Haughton | Louisiana | 71037 | — |
| University of Maryland School of Medicine ( Site 0041) | Baltimore | Maryland | 21201 | — |
| St Michaels Med Center ( Site 0285) | Newark | New Jersey | 07102 | — |
| Albuquerque Clinical Trials ( Site 0052) | Albuquerque | New Mexico | 87102 | — |
| Mid Hudson Medical Research ( Site 0294) | New Windsor | New York | 12553 | — |
| Carolina Women's Research and Wellness Center ( Site 0035) | Durham | North Carolina | 27713 | — |
| PMG Research of Raleigh, LLC ( Site 0048) | Raleigh | North Carolina | 27609 | — |
| PMG Research of Wilmington ( Site 0006) | Wilmington | North Carolina | 28401 | — |
| Cincinnati Children's Hospital Medical Center ( Site 0003) | Cincinnati | Ohio | 45229 | — |
| Senders Pediatrics ( Site 0060) | Cleveland | Ohio | 44121 | — |
| Rapid Medical Research, Inc. ( Site 0038) | Cleveland | Ohio | 44122 | — |
| Lynn Health Science Institute ( Site 0287) | Oklahoma City | Oklahoma | 73112 | — |
| Coastal Pediatric Research ( Site 0010) | Charleston | South Carolina | 29414 | — |
| Parkside Pediatric ( Site 0288) | Greenville | South Carolina | 29607 | — |
| Coastal Carolina Research Center ( Site 0053) | Mt. Pleasant | South Carolina | 29464 | — |
| Palmetto Clinical Research ( Site 0289) | Summerville | South Carolina | 29485 | — |
| Tekton Research, Inc. ( Site 0036) | Austin | Texas | 78745 | — |
| Coastal Bend Clinical Research ( Site 0299) | Corpus Christi | Texas | 78413 | — |
| Radiant Research - Dallas ( Site 0045) | Dallas | Texas | 75234 | — |
| University of Texas Medical Branch at Galveston ( Site 0049) | Galveston | Texas | 77555-1115 | — |
| Juno Research, LLC ( Site 0293) | Houston | Texas | 77074 | — |
| Accurate Clinical Management, LLC ( Site 0028) | Pasadena | Texas | 77504 | — |
| Diagnostics Research Group ( Site 0001) | San Antonio | Texas | 78229 | — |
| Synexus Research ( Site 0058) | San Antonio | Texas | 78229 | — |
| Crossroads Clinical Research LLC ( Site 0283) | Victoria | Texas | 77901 | — |
| Health Research of Hampton Roads, Inc. ( Site 0014) | Newport News | Virginia | 23606 | — |
| Clinical Research Associates of Tidewater ( Site 0056) | Norfolk | Virginia | 23507 | — |
| York Clinical Research, LLC ( Site 0033) | Norfolk | Virginia | 23510 | — |
| National Clinical Research-Richmond, Inc. ( Site 0051) | Richmond | Virginia | 23294 | — |
| Multicare / Rockwood Clinic ( Site 0034) | Spokane | Washington | 99202 | — |
| Premier Clinical Research Group ( Site 0050) | Spokane | Washington | 99202 | — |
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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03486834, 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 Jan 23, 2024 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03486834 live on ClinicalTrials.gov.