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A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501974-21-00
Acronym
V503-049
Enrollment
1495
Registered
2022-11-29
Start date
2020-04-01
Completion date
Unknown
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

18, 31, 33, 45, 52, and 58, Prevention of oral persistent infection caused by any of the human papillomavirus types 16

Brief summary

Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

Detailed description

Incidence of HPV 6/11-related 6-month Persistent Oral Infection, Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies, Percentage of Participants Who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58, Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE), Percentage of Participants with Elevated Temperature (Fever), Percentage of Participants Who Report at Least 1 Systemic AE, Percentage of Participants Who Experience at Least 1 Serious Adverse Event, Percentage of Participants Who Experience at Least 1 Serious Vaccine-related AE

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

Secondary

MeasureTime frame
Incidence of HPV 6/11-related 6-month Persistent Oral Infection, Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies, Percentage of Participants Who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58, Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE), Percentage of Participants with Elevated Temperature (Fever), Percentage of Participants Who Report at Least 1 Systemic AE, Percentage of Participants Who Experience at Least 1 Serious Adverse Event, Percentage of Participants Who Experience at Least 1 Serious Vaccine-related AE

Countries

Belgium, Czechia, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026