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A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared with a Standard 3-dose Regimen in 16- to 26-Year Old Women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500256-37-00
Acronym
V503-069
Enrollment
80
Registered
2022-09-09
Start date
2021-04-08
Completion date
Unknown
Last updated
2025-09-17

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

Conditions

11, 16, 18, 31, 33, 45, 52, and 58, Prevention of persistent anogenital HPV infection and disease caused by HPV Types 6

Brief summary

Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay at 4 Weeks Post Last Vaccination, Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event, Percentage of Participants With at Least 1 Systemic Adverse Event, Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event

Detailed description

Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 Weeks Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination

Interventions

DRUGGardasil 9 suspension for injection in a pre-filled syringe Human Papillomavirus 9-valent Vaccine (Recombinant
DRUGadsorbed)

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay at 4 Weeks Post Last Vaccination, Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event, Percentage of Participants With at Least 1 Systemic Adverse Event, Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event

Secondary

MeasureTime frame
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 Weeks Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 12 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 24 Months Post Last Vaccination, Geometric Mean Titers (Cohorts 1 to 5) of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccination, Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 36 Months Post Last Vaccinatio

Countries

Poland

Outcome results

None listed

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