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

BR-DTPP-CT-301

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.

2015-02-02

2017-12-19

2018-05-05

Completed

Early phase I

476

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 476, 'type': 'ACTUAL'}}

2023-06-28