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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Coronavirus Disease (COVID-19); Papillomavirus Infections

Treatments: Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05119855

2021-003591-13 (EudraCT Number)

V503-076

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Concomitant Group

Experimental group

Description:

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.

Treatment:

Biological: mRNA-1273 Vaccine

Biological: 9vHPV Vaccine

Non-concomitant Group

Experimental group

Description:

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.

Treatment:

Biological: mRNA-1273 Vaccine

Biological: 9vHPV Vaccine