Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine … (NCT06243666) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
China2,188 participantsStarted 2024-02-20
Plain-language summary
The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Participants must be at least 18 years old;
* Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group);
* Able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form;
Exclusion Criteria:
* Participants who did not experience sexual debut;\*
* Participants with acute cervical inflammation and acute lower genital tract infection;\*
* Participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;\*
* Participants in the vaccine group have used other HPV vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508); Participants in the control group have used HPV vaccine products (including both marketed and unmarketed vaccines);
* According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study.
* Note: For criteria marked with an asterisk (\*), if …
What they're measuring
1
Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18
Timeframe: 8-10 years after the first dose
2
Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations