drugset / Trial / 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)

NCT05119855

Phase 3 Completed 165 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2022-03-28
Primary completion
2023-12-12
Completion
2023-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Elasomeran Messenger RNA (mRNA) 50 ug Intramuscular
Subject Gardasil 9 Vaccine 0.5 ml Intramuscular