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)
Completed · Phase 3
Conditions studied: Papillomavirus Infections, Coronavirus Disease (COVID-19)
In brief
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.
Key facts
- Study ID
- NCT05119855
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 165
- Starts
- 2022-03-28
- Expected to finish
- 2023-12-12
- Last updated by the study team
- 2026-02-05
Who can join
Age: 9 and older, up to 11. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- 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
- Females only: participant is pregnant
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- 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
Where it is running
- Cognitive Clinical Trials, LLC ( Site 0054) — Phoenix, Arizona, United States
- Eclipse Clinical Research ( Site 0095) — Tucson, Arizona, United States
- Children's Clinic of Jonesboro, PA ( Site 0044) — Jonesboro, Arkansas, United States
- Preferred Research Partners Inc. ( Site 0092) — Little Rock, Arkansas, United States
- Coast Clinical Research, LLC ( Site 0027) — Bellflower, California, United States
- Ark Clinical Research ( Site 0098) — Long Beach, California, United States
- Valley Clinical Trials Inc. ( Site 0004) — Northridge, California, United States
- Medical Center for Clinical Research ( Site 0051) — San Diego, California, United States
- Ark Clinical Research ( Site 0108) — Tustin, California, United States
- Emerson Clinical Research Institute ( Site 0021) — Washington D.C., District of Columbia, United States
- Accel Research Sites-DeLand Clinical Research Unit ( Site 0066) — DeLand, Florida, United States
- Advanced Research for Health Improvement, LLC ( Site 0012) — Immokalee, Florida, United States
- Acevedo Clinical Research Associates ( Site 0001) — Miami, Florida, United States
- Alpha Science Research ( Site 0067) — Miami, Florida, United States
- Advanced Research For Health Improvement LLC ( Site 0075) — Naples, Florida, United States
- Comprehensive Clinical Research ( Site 0038) — West Palm Beach, Florida, United States
- Atlanta Center for Medical Research ( Site 0055) — Atlanta, Georgia, United States
- Mount Vernon Clinical Research ( Site 0053) — Sandy Springs, Georgia, United States
- Clinical Research Prime ( Site 0088) — Idaho Falls, Idaho, United States
- CBH Health ( Site 0019) — Gaithersburg, Maryland, United States
- SKY Integrative Medical Center/SKYCRNG ( Site 0084) — Ridgeland, Mississippi, United States
- Midwest Children's Health Research Institute ( Site 0003) — Lincoln, Nebraska, United States
- Certified Research Associates ( Site 0090) — Cortland, New York, United States
- Corning Center for Clinical Research ( Site 0091) — Horseheads, New York, United States
- Carolina Institute for Clinical Research, LLC ( Site 0042) — Fayetteville, North Carolina, United States
Full record on ClinicalTrials.gov
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