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NCT05119855 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
NCT05119855: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT05119855 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 165 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05119855, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
Study 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.
Primary Outcome
Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific.
Interventions
- BIOLOGICAL 9vHPV Vaccine
- BIOLOGICAL mRNA-1273 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2023-12-12 |
| Phase | Phase 3 |
What the finished NCT05119855 record still lists
NCT05119855 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which 9vHPV Vaccine is the first listed.
NCT05119855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05119855 about?
NCT05119855 is a clinical study titled "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)". 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 gir...
What is the current status of trial NCT05119855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2022-03-28. Estimated completion is 2023-12-12.
What interventions are being tested in trial NCT05119855?
The interventions under investigation include: 9vHPV Vaccine (BIOLOGICAL), mRNA-1273 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05119855?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05119855's enrollment target sits among peer trials
165 1465th of 2000 higher than 531 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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