Clinical trial NCT03206255: Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
Official title: Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Vaginal Intraepithelial Neoplasia
Vulvar Intraepithelial Neoplasia
Persistent Infection
Keywords: Human Papilloma Virus 16
Human Papilloma Virus 18
adolescent girl
non-inferiority
immuno-persistence
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
First posted: 2017-07-02
Enrollment: 940
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who participated in the bridging study (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose will be recruited.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody)
timeFrame: Month 18 and 30
Secondary outcomes:
measure: Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody)
timeFrame: Month 18 and 30
measure: All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded
timeFrame: between 7 months and 30months after the dose1
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Centre for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Xiamen University
name: Ting Wu, Ph. D.
role: STUDY_CHAIR
affiliation: Jiangsu Provincial Centre for Disease Control and Prevention
name: Yuemei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: