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 Sex
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 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.
  • 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 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.
  • 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

More Details

Status
Completed
Sponsor
Merck Sharp & Dohme LLC

Study Contact