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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 9
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Center for Disease Control and Prevention
RECRUITING
Mianyang
Yangchun Center For Disease Prevention And Control
RECRUITING
Yangchun
Contact Information
Primary
Jikai Zhang
56061237@qq.com
020-89020236
Time Frame
Start Date: 2022-05-14
Estimated Completion Date: 2027-05
Participants
Target number of participants: 600
Sponsors
Leads: Shanghai Bovax Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov