NCT05119855

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)

A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Papillomavirus Infections
• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
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
BIOLOGICAL	mRNA-1273 Vaccine	mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2021-11-15
• Last updated: 2026-02-05
• Results posted: 2025-07-17

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study