This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,382
Three doses administered intramuscularly at 0, 1 and 6 month.
Two doses administered intramuscularly at 0 and 6 month.
Sichuan Provincial Centre for Disease Control and Prevention
Chengdu, Sichuan, China
Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-26 years old receiving 3 doses of the nonavalent vaccine
To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-17 years receiving 3 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
Time frame: 7 months after the first dose
Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-14 years old receiving 2 doses of the nonavalent vaccine
To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-14 years receiving 2 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
Time frame: 7 months after the first dose
Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at months 18 and 30 in the population aged 9-14 and 15-17 years old receiving 2 doses or 3 doses of the nonavalent vaccine
To determine the immune persistence (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at months 18 and 30 in the population receiving 2 doses or 3 doses of the nonavalent vaccine
Time frame: 30 months after the first dose
Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Time frame: During the 7-day period following each vaccination
Safety2: Adverse events/reactions occurred within 30 days after each vaccination.
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Adverse events/reactions occurred within 30 days after each vaccination.
Time frame: Within 30 days (Day 0-30) after any vaccination
Safety3: Severe adverse events occurred throughout the study.
Severe adverse events occurred throughout the study. To evaluate number of SAEs between the different arms.
Time frame: Up to 8 month
Safety4: Pregnancy and pregnancy outcome.
Pregnancy and pregnancy outcome. To evaluate number of births and terminations between the different arms.
Time frame: Up to 8 month