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

Jun Zhang

Status

Completed

Conditions

Vaginal Intraepithelial Neoplasia

Vulvar Intraepithelial Neoplasia

Persistent Infection

Cervical Intraepithelial Neoplasia

Cervical Cancer

Treatments

Procedure: 3 doses of HPV 16/18 bivalent vaccine

Procedure: 2 doses of HPV 16/18 bivalent vaccine

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03206255

HPV-PRO-006-2

Details and patient eligibility

About

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).

Full description

This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.

Enrollment

940 patients

Sex

Female

Ages

10 to 28 years old

Volunteers

Accepts Healthy Volunteers

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;