Purpose

The primary hypothesis is that concomitant administration of the first doses of a 2-dose regimen of 9vHPV vaccine and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND noninferior geometric mean concentrations (GMCs) of SARS-CoV-2 spike protein-specific binding antibody at 4 weeks Postdose 2 of mRNA-1273 vaccine, compared with the corresponding postdose 2 GMTs/GMCs induced by a 2-dose regimen of 9vHPV vaccine and mRNA-1273 vaccine, where the first doses of each are administered nonconcomitantly.

Conditions

Eligibility

Eligible Ages
Between 9 Years and 11 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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).

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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Concomitant Group
Participants will receive the first dose of 9vHPV vaccine and first dose of mRNA-1273 vaccine on Day 1; participants will then receive the second dose of mRNA-1273 vaccine at Month 1 and the second dose of 9vHPV vaccine at Month 6.
  • Biological: 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
    Other names:
    • V503
    • GARDASIL®9
    • SILGARD®9
  • Biological: mRNA-1273 Vaccine
    mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
    Other names:
    • SARS-CoV-2 Vaccine
    • Moderna COVID-19 Vaccine
Experimental
Non-concomitant Group
Participants will receive the first and second doses of mRNA-1273 vaccine on Day 1 and at Month 1, respectively; participants will then receive the first and second doses of 9vHPV vaccine at Months 2 and 8, respectively.
  • Biological: 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
    Other names:
    • V503
    • GARDASIL®9
    • SILGARD®9
  • Biological: mRNA-1273 Vaccine
    mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
    Other names:
    • SARS-CoV-2 Vaccine
    • Moderna COVID-19 Vaccine

Recruiting Locations

University of Texas Medical Branch ( Site 0026)
League City, Texas 77573
Contact:
Study Coordinator
832-340-2313

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.