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Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

Phase 3
Completed
Conditions
Pertussis
Tetanus
Poliomyelitis
Diphtheria
Registration Number
NCT02458183
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Vaccine response rate4 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 Outcome Measures
NameTimeMethod
Geometric mean titer (GMT)4 weeks after the three-dose primary vaccination

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

Trial Locations

Locations (20)

Inje University Busan Paik Hospital

🇰🇷

Busan, Korea, Republic of

KeiMyung University Dongsan Medical Center

🇰🇷

Daegu, Korea, Republic of

Gwangmyeong Sungae Hospital

🇰🇷

Gyeonggi-do, Korea, Republic of

Wonkwang University Hospital

🇰🇷

Iksan, Korea, Republic of

Inha University Hospital

🇰🇷

Incheon, Korea, Republic of

Pusan National University Yangsan Hospital

🇰🇷

Pusan, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Cheil General Hospital

🇰🇷

Seoul, Korea, Republic of

Chung-Ang University Hospital

🇰🇷

Seoul, Korea, Republic of

Eulgi General Hospital

🇰🇷

Seoul, Korea, Republic of

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Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of

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