This Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years
This is a randomized, observer blinded, active controlled, multicenter clinical study. A total of approximately 1,260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled, and be randomly assigned into 2 groups in a 1:1 ratio. Immunogenicity: Blood samples (5.0 mL each time) will be collected for all participants prior to the 1st dose of vaccination and on 1, 6, 12, 18 months after full vaccination for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and Immunoglobulin G antibodies testing. Safety evaluation (for all participants):To assess solicited (local and systemic) Adverse Event (AEs) within 7 days after each dose of vaccination, unsolicited Adverse Event (AEs) within 30 days after each dose of vaccination, and Serious Adverse Event (SAEs) from 1st dose to 18 months after full vaccination. Collection of pregnancy events:To assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination. The subject will be followed to determine the outcome of the pregnancy. At the end of the pregnancy, be it a full-term or premature birth, information on the status of the newborn(s) will be followed up during the first 12 months of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,260
A 3-dose regimen administered at months 0, 2 and 6.
A 3-dose regimen administered at months 0, 2 and 6.
University of Muhammadiyah Malang Hospital
Malang, Indonesia
Geometric mean titer (GMT) for anti-HPV neutralizing antibodies 30 days after full vaccination
Geometric mean titer (GMT) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.
Time frame: 30 days after full vaccination
Seroconversion Rate (SCR) for anti-HPV neutralizing antibodies 30 days after full vaccination
Seroconversion Rate (SCR) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.
Time frame: 30 days after full vaccination
Geometric mean titer (GMT) of anti-HPV immunoglobulin G antibodies 30 days after full vaccination
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.
Time frame: 30 days after full vaccination
Seroconversion Rate (SCR) of anti-HPV immunoglobulin G antibodies 30 days after full vaccination
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.
Time frame: 30 days after full vaccination
Geometric mean titer (GMT) of anti-HPV neutralizing antibodies and immunoglobulin G antibodies 6,12,18 months after full vaccination
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.
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Time frame: 6 months, 12 months and 18 months after full vaccination
Seroconversion Rate (SCR) of anti-HPV neutralizing antibodies and immunoglobulin G antibodies 6,12,18 months after full vaccination
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.
Time frame: 6 months, 12 months and 18 months after full vaccination
Incidenct, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of vaccination
Incidenct, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of vaccination.
Time frame: 0-7 days after each dose of vaccination
Incidenct, severity and duration of each unsolicited AE within 30 days after each dose of vaccination
Incidenct, severity and duration of each unsolicited AE within 30 days after each dose of vaccination.
Time frame: 0-30 days after each dose of vaccination
Incidence, severity and causality of SAE and incidence of pregnancy events from 1st dose to 18 months after full vaccination
Incidence, severity and causality of SAE and incidence of pregnancy events from 1st dose to 18 months after full vaccination.
Time frame: from 1st dose to 18 months after full vaccination