Clinical trial NCT05371353: Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
Official title: Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infections
Cervical Cancer Stage IIa
Vaginal Cancer
Genital Wart
CIN1
CIN2
CIN3
Keywords: Human papillomavirus
vaccine
Cervical Cancer
Lead sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 600
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 9-45 years old have completed receiving three doses of quadrivalent HPV vaccine and provided blood sample at month 7

Brief summary: To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.


Eligibility criteria: Inclusion Criteria:

* Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
* The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
* The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
* Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion Criteria:

* Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
* Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
* According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Primary outcomes:
measure: Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 12
measure: SCR for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 24
measure: SCR for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 36
measure: SCR for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 48
measure: SCR for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 60
measure: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 12
measure: GMTs for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 24
measure: GMTs for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 36
measure: GMTs for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 48
measure: GMTs for Each of the HPV Types Contained in the Vaccine
timeFrame: Month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Yangchun
country: China
facility: Yangchun Center For Disease Prevention And Control
state: Guangdong
city: Mianyang
country: China
facility: Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Jikai Zhang
role: STUDY_DIRECTOR
References: