A Phase 3 interventional study of 2-doses Group among 9-14 years and 3-doses Group among 9-19 years in HPV Infections, Cervical Cancer Stage IIa and Vaginal Cancer, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 9 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 3, Interventional, and Prevention
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.
This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.
Exclusion Criteria:
Subjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule.
Biological: 2-doses Group among 9-14 years
Subjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.
Biological: 3-doses Group among 9-19 years
Subjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.
Biological: 3-doses Group among 20-26 years
Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
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 8
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 60
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 vaccination
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 vaccination
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 vaccination
Number of subjects receiving the whole schedule vaccination with SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
Number of subjects with pregnancy events
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA) , Live infant, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Time frame: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
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Shanghai Bovax Biotechnology Co., Ltd.