The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP\~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP\~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative. Primary Objective * To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid \[PT\] and filamentous haemagglutinin \[FHA\]) of Group A versus Group B, one month after the third dose of combined vaccines. Secondary Objectives: * To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines. * To study the safety after each and any dose of vaccines administered in the two vaccination schemes
Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP\~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP\~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
310
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Daejeon, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Gyeongsangnam Do, South Korea
Unnamed facility
Gyeongsangnam Do, South Korea
Unnamed facility
Jeollabuk Do, South Korea
Unnamed facility
Jeonbuk, South Korea
Unnamed facility
Kangwon Do, South Korea
Unnamed facility
Kyunggi Do, South Korea
Unnamed facility
Seoul, South Korea
...and 6 more locations
Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 International Units (IU)/mL
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Time frame: 1 month post third vaccination
Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 International unit (IU)/mL
Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: 1 month post third vaccination
Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3
Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: I month post dose 3
Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL and ≥ 0.1 IU/mL International Units (IU)/mL
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Time frame: Day 0 Pre-vaccination
Number of participants with anti-Hepatitis B antibody concentrations ≥ 10 mIU/mL international unit (IU)/mL
Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology
Time frame: Day 0 Pre-vaccination
Number of participants with anti Diphtheria antibody concentrations ≥ 0.1 IU/mL International Units (IU)/mL
Anti-Diphtheria antibodies will be measured by a toxin neutralization test
Time frame: 1 month post third vaccination
Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine
Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.
Time frame: Day 0 and up to Day 180 post-vaccination
Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens
Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is \< 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ
Time frame: 1 month post third vaccination
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