The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.
This is a parallel-controlled study. A total of 2,750 participants will be enrolled in this study: 9-14 years (2 doses) group and 9-19 years (3 doses) group are of non-randomized, open label design; 20-26 years (3 doses) group will be randomized and blinded. 9-14 age group and group 9-19 age group will be enrolled in two stages: 20 subjects in 9-19 age group will be enrolled first. After assessing the safety data (including laboratory test data) within 7 days of 1st dose vaccination in these 20 subjects, and if the suspension criteria are not met, the remaining 620 subjects in 9-19 age group and 640 subjects in 9-14 age group will be enrolled subsequently. 20-26 age group will be enrolled directly, with no stage entry requirements. Eligible subjects will be enrolled to received vaccines accordingly. Subjects who have reached menarche will undergo urine pregnancy test prior to each dose of vaccination (on the vaccine day.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,750
9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.
20-26 years possitive control group will be vaccinated at months 0, 2 and 6
Yunnan Center for Disease Prevention and Control
Kunming, Yunnan, China
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.
Time frame: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group
Time frame: 30 days after full immunization
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group
Time frame: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group
Time frame: 30 days after full immunization
GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.
Time frame: 30 days after full immunization
SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.
Time frame: 30 days after full immunization
GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.
Time frame: From the 12th month to 72nd month after first dose immunization
SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.
Time frame: From the 12th month to 72nd month after first dose immunization
Abnormality rate of laboratory test
First 20 subjects enrolled in 9-19 years group: abnormality rate of laboratory test on Day 3 after each dose of vaccination.
Time frame: Day 3 after each dose
Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs
Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs within 30 minutes after each dose of vaccination for all participants
Time frame: 30 minutes after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose of vaccination for all participants
Time frame: 0-7 days after each dose
Collect the questionnaires to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose of vaccination for all participants
Time frame: 0-30 days after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of SAE
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of SAE which within 72 months after first vaccination for all participants.
Time frame: Through study completion, an average of 6 years
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of the occurrence of pregnancy events
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of the occurrence of pregnancy events which within 72 months after first vaccination for all participants
Time frame: Through study completion, an average of 6 years
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