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)

Purpose

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.

Conditions

  • Papillomavirus Infections
  • Coronavirus Disease (COVID-19)

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

More Details

NCT ID
NCT05119855
Status
Completed
Sponsor
Merck Sharp & Dohme LLC