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NCT06243666Active, not recruiting

Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

Source: ClinicalTrials.gov · Last updated 31 Jul 2025

Brief summary (registry, in English)

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2188 (estimated)
First submitted
29 Jan 2024
Start date
20 Feb 2024
Primary completion date
31 Dec 2026
Lead sponsor
Xiamen University
NCT number
NCT06243666

What you commit to

  • Study type: Observational
  • Planned participants: 2188
  • From 20 Feb 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;\*
  • Participants in the vaccine group have used other HPV vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508); Participants in the control group have used HPV vaccine products (including both marketed and unmarketed vaccines);

Other illness

  • Participants with acute cervical inflammation and acute lower genital tract infection;\*

Other

  • Participants who did not experience sexual debut;\*
  • According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study.
    • Note: For criteria marked with an asterisk (\*), if the participant meets that exclusion criterion, it does not affect the blood sample collection.

Who the study is looking for

  • Participants must be at least 18 years old;
  • Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group);
  • Able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form;

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sheyang County Center for Disease Control and Prevention
Coordinator of this site? Confirm its status
YanchengChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.