This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
336
DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
Seroprotection/vaccine-response rate
* Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens
Time frame: 1 month after the third dose primary series
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Time frame: 1 month after the third dose primary series
Seroconversion rate
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Time frame: 1 month after the third dose primary series
Long-term seroprotection rate
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Time frame: 1 month after the third dose primary series
Solicited adverse event
Expected local or systemic side effects after vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse event
Any AEs other than solicited AEs
Time frame: 1 month after each vaccinations
Immediate reactions after vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
Time frame: 30 minutes after each vaccination
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