9vHPV + COVID-19 Vaccines for HPV and Coronavirus Prevention

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

This trial is for boys and girls aged 9 to 11 who haven't started sexual activity and won't during the study. They must be able to use an electronic report card for vaccination feedback. It's not for those with a history of heart inflammation, recent COVID-19 or related syndromes, blood disorders, immunosuppression, prior HPV vaccination, severe allergies or missing spleen.

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).

You or your child must be between 9 and 11 years of age.

Exclusion Criteria

Received any immunoglobulin product or blood-derived product within 3 months

You have a history of heart muscle or heart sac inflammation.

Receiving or has received immunosuppressive therapies within the last year

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Treatment Details

Interventions

9vHPV Vaccine (Virus Vaccine)
mRNA-1273 Vaccine (Virus Vaccine)

Trial OverviewThe study tests the safety and immune response when giving two vaccines together: the 9vHPV vaccine against human papillomavirus and mRNA-1273 vaccine against COVID-19. The goal is to see if getting both at once works as well as when they're given separately.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Non-concomitant GroupExperimental Treatment2 Interventions

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.

Group II: Concomitant GroupExperimental Treatment2 Interventions

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.