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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

Conditions
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Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection

Intervention / Treatment
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* Procedure: 3 doses of HPV 16/18 bivalent vaccine
* Procedure: 2 doses of HPV 16/18 bivalent vaccine


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 9-17y (0,1,6m)<br>Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine | Procedure: 3 doses of HPV 16/18 bivalent vaccine<br>* Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)<br>|
| 9-14y (0,6m)<br>Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine | Procedure: 2 doses of HPV 16/18 bivalent vaccine<br>* Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)<br>|
| 18-26y (0,1,6m)<br>Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine | Procedure: 3 doses of HPV 16/18 bivalent vaccine<br>* Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody) | To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1 | Month 18 and 30 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papilloma Virus 16, Human Papilloma Virus 18, adolescent girl, non-inferiority, immuno-persistence