The purpose of this study is to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli) (HPV)and Measles Mumps and Rubella Combined Vaccine, Live(MMR)
Main subjects: To evaluate the immunogenicity of HPV vaccine and MMR vaccine at the same time but at different sites as not inferior to vaccination of HPV vaccine or MMR vaccine alone. Secondary subjects: To evaluate the safety of simultaneous administration of HPV vaccine and MMR vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Simultaneously administrated with MMR vaccine and HPV 16/18 bivalent vaccine at first. And six months later, administrated with the second dose of HPV 16/18 bivalent vaccine.
Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine.
Administrated with MMR vaccine at first day. And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months).
Yuecheng Center for Disease Control and Prevention
Shaoxing, Zhejiang, China
Wuyi Center for Disease Control and Prevention
Wuyi, Zhejiang, China
Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody)
Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the second dose to determine whether group A is non-inferior to group B
Time frame: Specific neutralizing antibodies at 7 months after first dose
Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination
Detect the level of anti-measles specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time frame: 1 months after vaccination
Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination
Detect the level of anti-rubella specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time frame: 1 months after vaccination
Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination
Detect the level of anti-mumps specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time frame: 1 months after vaccination
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: During the 7-day (Day 0-6) period following each vaccination
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Adverse events/reactions occurred within 30 days after each vaccination
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: Within 30 days (Day 0-30) after any vaccination
Serious adverse events occurred throughout the study
safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group.
Time frame: Up to 7 months