NCT05119855CompletedPhase 3
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 10 Nov 2021
- Start date
- 28 Mar 2022
- Primary completion date
- 12 Dec 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05119855
- EudraCT number
- 2021-003591-13
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 165
- From 28 Mar 2022 to the primary completion date, 12 Dec 2023
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of a clinical or microbiological diagnosis of COVID-19 ≤90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Other illness
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Has a history of myocarditis or pericarditis
Other
- Females only: participant is pregnant
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
Who the study is looking for
- Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
- Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
Age in the registry: 9 years to 11 years · Sex: All · Accepts healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta Center for Medical Research ( Site 0055) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| DermResearch, Inc. ( Site 0056) Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Coast Clinical Research, LLC ( Site 0027) Coordinator of this site? Confirm its status | Bellflower | United States | Unknown status |
| WR-ClinSearch ( Site 0049) Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| South Texas Clinical Research ( Site 0024) Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Certified Research Associates ( Site 0090) Coordinator of this site? Confirm its status | Cortland | United States | Unknown status |
| Dayton Clinical Research ( Site 0028) Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Accel Research Sites-DeLand Clinical Research Unit ( Site 0066) Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| South Texas Pediatric Research Group ( Site 0094) Coordinator of this site? Confirm its status | Del Rio | United States | Unknown status |
| Carolina Institute for Clinical Research, LLC ( Site 0042) Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| CBH Health ( Site 0019) Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Corning Center for Clinical Research ( Site 0091) Coordinator of this site? Confirm its status | Horseheads | United States | Unknown status |
| Next Level Urgent Care, LLC ( Site 0099) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| West Houston Clinical Research Services ( Site 0078) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Research Prime ( Site 0088) Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Advanced Research for Health Improvement, LLC ( Site 0012) Coordinator of this site? Confirm its status | Immokalee | United States | Unknown status |
| Children's Clinic of Jonesboro, PA ( Site 0044) Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Milton Haber, M.D. ( Site 0069) Coordinator of this site? Confirm its status | Laredo | United States | Unknown status |
| University of Texas Medical Branch ( Site 0026) Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| Midwest Children's Health Research Institute ( Site 0003) Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Preferred Research Partners Inc. ( Site 0092) Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Ark Clinical Research ( Site 0098) Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Alpha Science Research ( Site 0067) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Acevedo Clinical Research Associates ( Site 0001) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Advanced Research For Health Improvement LLC ( Site 0075) Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Valley Clinical Trials Inc. ( Site 0004) Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Thomas Jefferson University - Family and Community Medicine ( Site 0006) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Cognitive Clinical Trials, LLC ( Site 0054) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| M3 Wake Research, Inc. ( Site 0014) Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| SKY Integrative Medical Center/SKYCRNG ( Site 0084) Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| University of Utah ( Site 0076) Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Medical Center for Clinical Research ( Site 0051) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Mount Vernon Clinical Research ( Site 0053) Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| Eclipse Clinical Research ( Site 0095) Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Ark Clinical Research ( Site 0108) Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Emerson Clinical Research Institute ( Site 0021) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Velocity Clinical Research, Salt Lake City ( Site 0025) Coordinator of this site? Confirm its status | West Jordan | United States | Unknown status |
| Comprehensive Clinical Research ( Site 0038) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.