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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05371353
Other study ID # 4-HPV-3003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 14, 2022
Est. completion date May 2027

Study information

Verified date April 2024
Source Shanghai Bovax Biotechnology Co., Ltd.
Contact Jikai Zhang
Phone 020-89020236
Email 56061237@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 9 Years to 45 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China Center for Disease Control and Prevention Mianyang Sichuan
China Yangchun Center For Disease Prevention And Control Yangchun Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Bovax Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 Month 12
Primary SCR for Each of the HPV Types Contained in the Vaccine The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 Month 24
Primary SCR for Each of the HPV Types Contained in the Vaccine The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 Month 36
Primary SCR for Each of the HPV Types Contained in the Vaccine The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 Month 48
Primary SCR for Each of the HPV Types Contained in the Vaccine The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 Month 60
Primary Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 Month 12
Primary GMTs for Each of the HPV Types Contained in the Vaccine The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 Month 24
Primary GMTs for Each of the HPV Types Contained in the Vaccine The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 Month 36
Primary GMTs for Each of the HPV Types Contained in the Vaccine The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 Month 48
Primary GMTs for Each of the HPV Types Contained in the Vaccine The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 Month 60
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