Cervical Cancer, Cervical Intraepithelial Neoplasia, Persistent Infection, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia
Conditions
Keywords
Human Papilloma Virus 16, Human Papilloma Virus 18, adolescent girl, non-inferiority, immuno-persistence
Brief 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).
Detailed 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.
Interventions
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Sponsors
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Jun Zhang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 28 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed