To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
330
Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China
RECRUITINGPercentage of Participants With Adverse Events
AE of local and systemic reactions within 30 minutes after each dose
Time frame: Up to 30 minutes after any vaccination
Percentage of Participants With Solicited Adverse Events
The percentage of participants with one or more solicited AEs was assessed.
Time frame: Up to 14 days after any vaccination
Percentage of Participants With Unsolicited Adverse Events
Percentage of Participants With Unsolicited Adverse Events
Time frame: Up to 30 days after any vaccination
Percentage of Participants With Serious Adverse Events
The percentage of participants with one or more SAEs was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Percentage of Female Participants With Pregnancy Events
The percentage of participants with Pregnancy Events was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Immunogenicity after receiving 3 doses of 15-HPV vaccine
Geometric mean titer (GMT) of anti-vaccine containing corresponding type of neutralizing antibody in subjects aged 18-45 years on the 31-day after the third dose of immunization
Time frame: Up to 31 days after the third vaccination
Immunogenicity of 15-HPV vaccine
Seroconversion rate (SCR)of the anti-vaccine containing the corresponding type of neutralizing antibody on day 31 after total immunization in subjects aged 18-45 years
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Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Time frame: Up to 31 days after the third vaccination
Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants
Geometric Mean Fold Increase (GMI) and 4-fold increase rates of anti-vaccine corresponding types of neutralizing antibodies in baseline seropositive subjects aged 18-45 years at day 31 after immunization
Time frame: Up to 31 days after the third vaccination