CompletedNot Applicable

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

China940 participantsStarted 2017-07-01

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 range10 Years – 28 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-006-2, Identifiers: NCT02562508) and received at least one dose;
✓. The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;
✓. Participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent;
✓. 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;

What they're measuring

Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody)

Timeframe: Month 18 and 30

Trial details

NCT IDNCT03206255

SponsorJun Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-08-15

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