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

N/ACompletedNCT03206255

Jun Zhang940 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

940

Conditions

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

Interventions

3 doses of HPV 16/18 bivalent vaccinePROCEDURE

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 vaccinePROCEDURE

Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 28 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: Month 18 and 30

Secondary Outcomes

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

Time frame: Month 18 and 30

All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded

Time frame: between 7 months and 30months after the dose1

Data from ClinicalTrials.gov

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