The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
A multinational, multicenter, randomized, comparative, open-label, phase 3 study Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
476
0.5-mL IM
0.5-mL IM
Inje University Busan Paik Hospital
Busan, South Korea
KeiMyung University Dongsan Medical Center
Daegu, South Korea
Vaccine response rate
Vaccine response rate of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination Criteria of vaccine response rate Anti-diphtheria: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-tetanus: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-PT, anti-FHA: Antibody titer at 4 weeks after the completion of the final vaccination is at least 4 times the baseline antibody titer anti-poliovirus type 1, 2, 3: Serum neutralizing antibody dilution ratio after the completion of the final vaccination ≥ 1:8
Time frame: 4 weeks after the three-dose primary vaccination
Geometric mean titer (GMT)
anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination
Time frame: 4 weeks after the three-dose primary vaccination
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Gwangmyeong Sungae Hospital
Gyeonggi-do, South Korea
Wonkwang University Hospital
Iksan, South Korea
Inha University Hospital
Incheon, South Korea
Pusan National University Yangsan Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Cheil General Hospital
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Eulgi General Hospital
Seoul, South Korea
...and 10 more locations