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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 476
- Locations
- 20
- Primary Endpoint
- Vaccine response rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Vaccine response rate
Time Frame: 4 weeks after the three-dose primary vaccination
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
Secondary Outcomes
- Geometric mean titer (GMT)(4 weeks after the three-dose primary vaccination)