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Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)

China979 participantsStarted 2021-02-06

Plain-language summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Who can participate

Age range14 Years – 32 Years

SexFEMALE

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Inclusion criteria

✓. Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose;
✓. Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
✓. Able to comply with the requests of the study;

Exclusion criteria

✕. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
✕. 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;
✕. Abnormal blood clotting function or coagulopathy

What they're measuring

Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type-specific IgG antibody)

Timeframe: Month 54

Trial details

NCT IDNCT04704908

SponsorJun Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-04-01

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