Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age9-26
SponsorShanghai Bovax Biotechnology Co., Ltd.
About this trial
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Chinese females aged 9 to 26 years; Provide legal identification;
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;
Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
No fever symptoms on the day of enrollment (aged> 14 years old, axillary temperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C );
Disqualifiers
Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
Enrolling or plan to enroll in other clinical trials (drug or vaccine);
History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
Trial design
Design model
Parallel
Treatments tested in this trial
2-doses Group among 9-14 years
Biological/VaccineSubjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
3-doses Group among 9-19 years
Biological/VaccineSubjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
3-doses Group among 20-26 years
Biological/VaccineSubjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Treatment groups
1,348 Participants
are divided into 3 treatment groupsGroup A: Experimental: 2-doses GroupExperimental treatment 1 intervention
Group B: Experimental: 3-doses GroupExperimental treatment 1 intervention
Group C: Acitve GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary immunogenicity outcome
Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 8
Time frame
At month 8Secondary outcomes
1
Secondary immunogenicity outcome
TNumber of subjects, aged 9 to 14, receiving the 2-doses scheduled vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 12, 24, 36, 48 and 60
Time frame
At month 12, 24, 36, 48 and 602
Number of subjecs with AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.3°C or 37.5°C) and urticaria.
Time frame
Within 30 minutes (Days 0) after vaccination3
Numbers of subjects with solication of AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.3°C or 37.5°C) and urticaria.
Time frame
Within 8 days (Days 0-8) after vaccination4
Numbers of subjects with unsolicited AEs
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame
Within days 0-30 after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Bovax Biotechnology Co., Ltd.
Lead sponsor
Chongqing Bovax Biopharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov