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Recruiting NCT05371353

Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

— Observational HPV Infections Cervical Cancer Stage IIa Vaginal Cancer Genital Wart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart. Basic parameters: 9 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Overview

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Primary outcome measures

  • Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine [Time frame: Month 12]
  • SCR for Each of the HPV Types Contained in the Vaccine [Time frame: Month 24]
  • SCR for Each of the HPV Types Contained in the Vaccine [Time frame: Month 36]
  • SCR for Each of the HPV Types Contained in the Vaccine [Time frame: Month 48]
  • SCR for Each of the HPV Types Contained in the Vaccine [Time frame: Month 60]
  • Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine [Time frame: Month 12]
  • GMTs for Each of the HPV Types Contained in the Vaccine [Time frame: Month 24]
  • GMTs for Each of the HPV Types Contained in the Vaccine [Time frame: Month 36]
  • GMTs for Each of the HPV Types Contained in the Vaccine [Time frame: Month 48]
  • GMTs for Each of the HPV Types Contained in the Vaccine [Time frame: Month 60]

Eligibility criteria

Inclusion criteria

  • Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
  • The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
  • The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
  • Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion criteria

  • Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
  • Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
  • According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

China · 2 centers
  • Yangchun Center For Disease Prevention And Control — Yangchun
  • Center for Disease Control and Prevention — Mianyang

Identifiers

NCT: NCT05371353 · 4-HPV-3003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗