This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the enrollment will be done according to the progression of age groups, from the oldest to the youngest, and the initial safety assessment will be conducted on the 8th day after the first dose of vaccination for each age group, and the next group will be enrolled only after the safety is confirmed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
Jiulongpo District Center for Disease Control and Prevention
Chongqing, China
Adverse reactions in all subjects
Time frame: Within 30 days of each dose of vaccine
Adverse reactions in all subjects
Time frame: Within 30 minutes of each dose of vaccine
Adverse events in all subjects
Time frame: Within 30 days of each dose of vaccine
Incidence of SAEs in all subjects
Time frame: From the first dose to 6 months after full vaccination
Incidence of abnormal and clinically significant (CS) white blood cell counts, hemoglobin, platelet counts, Alanine aminoTransferase (ALT), Aspartate Transaminase (AST), and TBIL assays in subjects 18-59, 2-5 years of age
Time frame: Day 8 post-immunization
Proportion of 2-month-old subjects with anti-Hib-PRP antibody concentrations ≥1.0 μg/ml
Time frame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
Positive transfer rate of anti-Hib-PRP antibodies in 2-month-old subjects
Time frame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
Positivity of anti-Hib-PRP antibodies in 2-month-old subjects
Time frame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
Geometric Mean Concentration (GMC) of anti-Hib-PRP antibodies in 2-month-old subjects
Time frame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization
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3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection
3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection
4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age, Intramuscular injection
4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age. Intramuscular injection
Geometric Mean Increase (GMI) of anti-Hib-PRP antibodies in 2-month-old subjects
Time frame: 30 days after basic immunization, before booster immunization, 30 days after booster immunization