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)

Last updated: June 30, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

mRNA-1273 Vaccine

9vHPV Vaccine

Clinical Study ID

NCT05119855
V503-076
2021-003591-13
  • Ages 9-11
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has not yet had coitarche and does not plan on becoming sexually active during thevaccination period

  • Participant or participant's legally acceptable representative can read, understand,and complete the electronic vaccination report card (eVRC).

Exclusion

Exclusion Criteria:

  • 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 priorto 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

Study Design

Total Participants: 165
Treatment Group(s): 2
Primary Treatment: mRNA-1273 Vaccine
Phase: 3
Study Start date:
March 28, 2022
Estimated Completion Date:
December 12, 2023

Connect with a study center

  • Cognitive Clinical Trials, LLC ( Site 0054)

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • Eclipse Clinical Research ( Site 0095)

    Tucson, Arizona 85745
    United States

    Site Not Available

  • Children's Clinic of Jonesboro, PA ( Site 0044)

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Preferred Research Partners Inc. ( Site 0092)

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Coast Clinical Research, LLC ( Site 0027)

    Bellflower, California 90706
    United States

    Site Not Available

  • Ark Clinical Research ( Site 0098)

    Long Beach, California 90815
    United States

    Site Not Available

  • Valley Clinical Trials Inc. ( Site 0004)

    Northridge, California 91325
    United States

    Site Not Available

  • Medical Center for Clinical Research ( Site 0051)

    San Diego, California 92120
    United States

    Site Not Available

  • Ark Clinical Research ( Site 0108)

    Tustin, California 92780
    United States

    Site Not Available

  • Emerson Clinical Research Institute ( Site 0021)

    Washington, District of Columbia 20011
    United States

    Site Not Available

  • Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)

    DeLand, Florida 32720
    United States

    Site Not Available

  • Advanced Research for Health Improvement, LLC ( Site 0012)

    Immokalee, Florida 34142
    United States

    Site Not Available

  • Acevedo Clinical Research Associates ( Site 0001)

    Miami, Florida 33142
    United States

    Site Not Available

  • Alpha Science Research ( Site 0067)

    Miami, Florida 33186
    United States

    Site Not Available

  • Advanced Research For Health Improvement LLC ( Site 0075)

    Naples, Florida 34102
    United States

    Site Not Available

  • Comprehensive Clinical Research ( Site 0038)

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Atlanta Center for Medical Research ( Site 0055)

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Mount Vernon Clinical Research ( Site 0053)

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Clinical Research Prime ( Site 0088)

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • CBH Health ( Site 0019)

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG ( Site 0084)

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Midwest Children's Health Research Institute ( Site 0003)

    Lincoln, Nebraska 68505
    United States

    Site Not Available

  • Certified Research Associates ( Site 0090)

    Cortland, New York 13045
    United States

    Site Not Available

  • Corning Center for Clinical Research ( Site 0091)

    Horseheads, New York 14845
    United States

    Site Not Available

  • Carolina Institute for Clinical Research, LLC ( Site 0042)

    Fayetteville, North Carolina 28303
    United States

    Site Not Available

  • M3 Wake Research, Inc. ( Site 0014)

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Dayton Clinical Research ( Site 0028)

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Thomas Jefferson University - Family and Community Medicine ( Site 0006)

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • WR-ClinSearch ( Site 0049)

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • DermResearch, Inc. ( Site 0056)

    Austin, Texas 78759
    United States

    Site Not Available

  • South Texas Clinical Research ( Site 0024)

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • South Texas Pediatric Research Group ( Site 0094)

    Del Rio, Texas 78840
    United States

    Site Not Available

  • Next Level Urgent Care, LLC ( Site 0099)

    Houston, Texas 77057
    United States

    Site Not Available

  • West Houston Clinical Research Services ( Site 0078)

    Houston, Texas 77055
    United States

    Site Not Available

  • Milton Haber, M.D. ( Site 0069)

    Laredo, Texas 78041
    United States

    Site Not Available

  • University of Texas Medical Branch ( Site 0026)

    League City, Texas 77573
    United States

    Site Not Available

  • University of Utah ( Site 0076)

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City ( Site 0025)

    West Jordan, Utah 84088
    United States

    Site Not Available

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