Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Tetanus, Diphtheria, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: DTaP-IPV combination vaccine
* Biological: DTaP vaccine and IPV vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Weeks
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTaP-IPV combination vaccine<br>Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months | Biological: DTaP-IPV combination vaccine<br>* 0.5-mL IM<br>|
| Active Comparator: DTaP vaccine and IPV vaccine<br>Product name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months. Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months. | Biological: DTaP vaccine and IPV vaccine<br>* 0.5-mL IM<br>* Other names: IPVAX INJ. PREFILLED SYRINGE INJ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks after the three-dose primary vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks after the three-dose primary vaccination |