The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants
Stage 1 (Phase 2) 1\. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age Stage 2 (Phase 3) 1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,186
Intramuscular injection into the anterolateral area of the thigh
Intramuscular injection into the anterolateral area of the thigh
Care CT Group
Dasmariñas, Cavite, Philippines
RECRUITINGSeroprotection/seroconversion rate
proportion of participants achieving pre-defined immune response to each antigen
Time frame: 4 weeks after a three-dose primary series
Geometric mean concentration (GMC) for pertussis
GMC for pertussis antigen
Time frame: 4 weeks after a three-dose primary series
Geometric mean titer (GMT) or GMC
GMT or GMC for all antigens
Time frame: 4 weeks after the three-dose primary series
Seroprotection/seroconversion rate
Proportion of participant achieving pre-defined immune response to each antigen
Time frame: 4 weeks after the three-dose primary series
Immediate reactions after vaccination
any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored
Time frame: 30 minutes after each vaccination
Solicited adverse event
local or systemic signs and symptoms
Time frame: within 7 days after each vaccination
Unsolicited adverse event
All adverse events other than solicited adverse event
Time frame: 4 weeks after the three-dose primary series
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