This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
627
HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3
Time frame: month 7
Solicited local adverse reactions
Solicited local adverse reactions occurred within 7 days after each vaccination;
Time frame: During the 7-day (Day 0-6) period following each vaccination
Solicited systematic adverse reactions
Solicited systematic adverse reactions occurred within 7 days after each vaccination;
Time frame: During the 7-day (Day 0-6) period following each vaccination
Unsolicited adverse events
Unsolicited adverse reactions occurred within 30 days after each vaccination;
Time frame: Within 30 days (Day 0-29) after any vaccination
Serious adverse events
Serious adverse events occurred throughout the study;
Time frame: throughout the study period, an average of 7 months
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