The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,100
sterile solution for intramuscular injection
Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan, China
Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose
Time frame: At Month 7
Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:40 prior to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Month 7
Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose
Time frame: 0~30 days after each vaccination
Incidence of solicited adverse events (AEs) after vaccination
Time frame: 0~7 days after each vaccination
Incidence of unsolicited AEs after vaccination
Time frame: 0~30 days after each vaccination
Incidence of serious adverse events (SAEs)
Time frame: Month 0 to Month 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.