This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,200
Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Geometric Mean Titers (GMT) of HPV neutralizing antibodies
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT
Time frame: 30 days postdose 3 (Month 7)
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Time frame: 30 days postdose 3 (Month 7)
Percentage of subjects reporting solicited local symptoms
Solicited local symptoms assessed including pain, redness, swelling, induration and pruritus.
Time frame: 0-7 days after each dose
Percentage of subjects reporting solicited general symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Time frame: 0-7 days after each dose
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: 0-30 days after each dose
Percentage of subjects reporting serious adverse events (SAEs)
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: Month 0 to Month 12
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