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Effectiveness of the prophylactic quadrivalent human papillomavirus vaccine in Chinese female: 10- and 15-year follow-up of the phase 3, double-blind, randomized, placebo-controlled V501-041 study

Effectiveness of the prophylactic quadrivalent human papillomavirus vaccine in Chinese female: 10- and 15-year follow-up of the phase 3, double-blind, randomized, placebo-controlled V501-041 study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052313
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-10-25
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Cervical Cancer

Interventions

unvaccinated group:N/A
early vaccination group (EVG):N/A
catch-up vaccination group (CVG):N/A

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Previously enrolled in the V501-041 study from the Shanxi research site; 2. Negative for any type of HPV 6/11/16/18 at the time of the first dose of vaccine; 3. There are currently no contraindications to screening; 4. The investigator believes that the subject has the ability to comply with the requirements of the protocol (such as participating in research visits, making telephone contacts); 5. Sign the written informed consent, fully understand the research procedure and agree to participate in the research.

Exclusion criteria

Exclusion criteria: Pregnant women.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of CIN 2+ related to HPV16/18;Seropositivity rates for HPV6/11/16/18;Geometric mean titers for HPV6/11/16/18;—

Secondary

MeasureTime frame
Cumulative incidence of genital warts related to HPV6/11/16/18;Cumulative incidence of CIN 1+ related to HPV6/11/16/18;—

Countries

China

Contacts

Public ContactZhao Fanghui

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

zhaofangh@cicams.ac.cn+86 10 87788977

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026