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

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.

• 3 doses of HPV 16/18 bivalent vaccine (Procedure): Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
• 2 doses of HPV 16/18 bivalent vaccine (Procedure): Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Primary outcomes

• Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody) [Month 18 and 30]: To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1

Secondary outcomes

• Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody) [Month 18 and 30]: To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 18 and 30 months after the dose 1
• All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded [between 7 months and 30months after the dose1]

Sex: Female, ages: 10 Years to 28 Years, accepts healthy volunteers

Inclusion Criteria:

1. 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;
2. The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;
3. 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;
4. Able to comply with the requests of the study;

Exclusion Criteria:

1. 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 ;
2. 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;

• Ting Wu, Ph. D., Study chair, Xiamen University
• Yuemei Hu, Bachelor, Principal investigator, Jiangsu Provincial Centre for Disease Control and Prevention