Phase 3
N=165
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)
Papillomavirus Infections · Coronavirus Disease (COVID-19)
Bottom Line
View on ClinicalTrials.gov: NCT05119855 ↗Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) — 2198.5; 1806.8; 1517.6; 1138.2 mMU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 9vHPV Vaccine (Biological); mRNA-1273 Vaccine (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) |
2198.5; 1806.8; 1517.6; 1138.2; 9595.8; 7042.3 | — |
| PRIMARY Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies |
763084.3; 650527.9 | — |
| PRIMARY Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) |
49.4; 39.5; 35.9; 26.9; 55.6; 44.9 | — |
| PRIMARY Percentage of Participants With ≥1 Solicited Systemic AE |
33.3; 33.3; 17.9; 37.0; 33.3; 16.7 | — |
| PRIMARY Percentage of Participants With ≥1 Serious Adverse Event (SAE) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With ≥1 Vaccine-Related SAE |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine |
96.4; 95.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05119855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.