UnknownNot Applicable

The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

China1,339 participantsStarted 2021-04-13

Plain-language summary

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

Who can participate

Age range26 Years – 54 Years

SexFEMALE

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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

Trial details

NCT IDNCT05045755

SponsorJun Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-10

Contact for this trial

Shaokai Zhang, Doctor

+86-371-65587346 shaokaizhang@126.com

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