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NCT05450705
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
Phase 3 trial testing 9vHPV vaccine in Papillomavirus Infections in 1,500 participants. Participants enrolled and being followed up; not accepting new ones.
3 August 2029
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,500 |
| Start date | 22 July 2022 |
| Primary completion | 3 August 2029 |
| Estimated completion | 3 August 2029 |
| Sites | 2 locations across China |
Drugs / interventions tested
- 9vHPV vaccine — full drug profile →
Conditions studied
- Papillomavirus Infections — all drugs for Papillomavirus Infections →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 9 to 26, female only, with Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05450705
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 9vHPV vaccine
Trials testing the same drug.
- NCT05314023 — Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053) · Phase 3 · active not recruiting
- NCT04772534 — Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066) · Phase 3 · completed
- NCT04708041 — Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069) · Phase 3 · active not recruiting
- NCT03546842 — Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males · Phase 3 · completed
Other recruiting trials for Papillomavirus Infections
Currently open trials in the same condition.
- NCT05797246 — Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP) · Phase 2 · active not recruiting
- NCT05285826 — Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052) · Phase 3 · active not recruiting
- NCT04724980 — Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis · Phase 1, PHASE2 · active not recruiting
- NCT04708041 — Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069) · Phase 3 · active not recruiting
- NCT04199689 — Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHP · Phase 3 · active not recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05450705 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 2 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05450705.
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