To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
90
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Center for Disease Control and Prevention
Mianzhu, Sichuan, China
Number of subjects with Adverse Events (AEs)
Subjects with solicited and unsolicited AEs
Time frame: From Day 0 to Month 7
Number of subjects with Severe adverse events (SAE)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Day 0 to Month 12
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT)
Immunogenicity were assessed by the GMT of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45
Time frame: day 31 post last dose
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate
Immunogenicity were assessed by the seroconversion rate of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination
Time frame: day 31 post last dose
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by IgG antibody GMT and seroconversion rate
Immunogenicity were assessed by the seroconversion rate and GMT of anti HPV6/11/16/18/33/45/52/58 IgG antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination
Time frame: day 31 post last dose
The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies
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Immunogenicity were assessed by the seroconversion rate and GMT (4-fold increase rate) of anti HPV6/11/16/18/33/45/52/58 IgG and neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seropositive before vaccination
Time frame: day 31 post last dose