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)
NCT ID: NCT05119855
Last Updated: 2026-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2022-03-28
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Concomitant Group
Participants will receive Dose 1 of 9-valent human papillomavirus \[Types 6, 11, 16, 18, 31, 33, 45, 52, 58\] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants will then receive Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.
9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Non-concomitant Group
Participants will receive Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants will then receive Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.
9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Interventions
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9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
Exclusion Criteria
* 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
9 Years
11 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
M3 Wake Research, Inc. ( Site 0014)
Raleigh, North Carolina, United States
Dayton Clinical Research ( Site 0028)
Dayton, Ohio, United States
Thomas Jefferson University - Family and Community Medicine ( Site 0006)
Philadelphia, Pennsylvania, United States
WR-ClinSearch ( Site 0049)
Chattanooga, Tennessee, United States
DermResearch, Inc. ( Site 0056)
Austin, Texas, United States
South Texas Clinical Research ( Site 0024)
Corpus Christi, Texas, United States
South Texas Pediatric Research Group ( Site 0094)
Del Rio, Texas, United States
West Houston Clinical Research Services ( Site 0078)
Houston, Texas, United States
Next Level Urgent Care, LLC ( Site 0099)
Houston, Texas, United States
Milton Haber, M.D. ( Site 0069)
Laredo, Texas, United States
University of Texas Medical Branch ( Site 0026)
League City, Texas, United States
University of Utah ( Site 0076)
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City ( Site 0025)
West Jordan, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2021-003591-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V503-076
Identifier Type: -
Identifier Source: org_study_id
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