UnknownNot Applicable

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

China647 participantsStarted 2021-03-30

Plain-language summary

The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Who can participate

Age range

26 Years – 54 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
. Participants can fully understand the study content and sign an informed consent form；
. Able to comply with the requests of the study;

Exclusion criteria

. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1

Timeframe: expected 2-3 years

Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1

Timeframe: expected 2-3 years

Trial details

NCT IDNCT04969445

SponsorJun Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-27

Contact for this trial

Chao Zhao, Doctor

+86-010-88324354 zhaochaocjr@163.com

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials

Who can participate

Age range

26 Years – 54 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
. Participants can fully understand the study content and sign an informed consent form；
. Able to comply with the requests of the study;

Exclusion criteria

. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

What they're measuring

Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1

Timeframe: expected 2-3 years

Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1

Timeframe: expected 2-3 years