Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants

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

Inclusion Criteria:

• Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
• Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
• Male and female infants who are identified to be healthy based on physical examination and medical history.

Exclusion Criteria:

• Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
• Subjects who have moderate or severe acute disease (regardless of fever).
• Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
• Subjects who have major congenital defects.
• Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
• Subjects who have abnormalities in the immune system, or congenital/acquired immune deficiency.
• Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
• Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
• Subjects who are allergic to the ingredients of the investigational products.
• Subjects who have received immunoglobulins or blood products or plan to get those medications.
• Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
• Subjects who are currently participating or planning to participate in other clinical studies during the study period.
• Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.