A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
Sichuan Provincial Center for Disease Prevention and Control
Chengdu, Sichuan, China
Percentage of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Time frame: During a 8-day period (Day 0-7) following each vaccination
Percentage of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Time frame: During a 8-day period (Day 0-7) following each vaccination
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Time frame: Within 31 days (Day 0-30) after any vaccination
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (up to Month 12)
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Time frame: 30 days after the third dose (Month 7)
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT
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Time frame: 30 days after the third dose (Month 7)