Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

NCT02458183 | Completed Phase 3 DMC

• 1 other identifier: BR-DTPP-CT-301
• Study Type: interventional
• Target: 476
• Locations: 2 countries
• Sites: 20

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.

Conditions

Diphtheria; Tetanus; Pertussis; Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Geometric mean titer (GMT)

  4 weeks after the three-dose primary vaccination

Other Outcomes (2)

• Solicited adverse event/adverse drug reaction

  24~26 weeks after the final vaccination

• Unsolicited adverse event/adverse drug reaction

  24~26 weeks after the final vaccination

Study Arms (2)

DTaP-IPV combination vaccine

EXPERIMENTAL

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

DTaP vaccine and IPV vaccine

ACTIVE COMPARATOR

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

Interventions

DTaP-IPV combination vaccine BIOLOGICAL

0.5-mL IM

DTaP-IPV combination vaccine

DTaP vaccine and IPV vaccine BIOLOGICAL

0.5-mL IM

Also known as: Boryung DTaP Vaccine Inj. (Prefilled syringe), IPVAX INJ. PREFILLED SYRINGE INJ

DTaP vaccine and IPV vaccine

Eligibility Criteria

• Age: 7 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (20)

Inje University Busan Paik Hospital

Busan, South Korea

Location

KeiMyung University Dongsan Medical Center

Daegu, South Korea

Location

Gwangmyeong Sungae Hospital

Gyeonggi-do, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Pusan National University Yangsan Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Cheil General Hospital

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Eulgi General Hospital

Seoul, South Korea

Location

Gangnam Sevrance Christian Hospital

Seoul, South Korea

Location

Hallym University Medical Center

Seoul, South Korea

Location

KEPCO Medical Center

Seoul, South Korea

Location

Korea Cancer Center Hospital

Seoul, South Korea

Location

KyungHee University Hospital at Gangdong

Seoul, South Korea

Location

KyungHee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Wonju Sevrance Christian Hospital

Wŏnju, South Korea

Location

Siriraj Hospital

Bangkok, Thailand

Location

Thammasat University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• HJ Jung

  Boryung Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: June 1, 2015
• Study Start: February 2, 2015
• Primary Completion: December 19, 2017
• Study Completion: May 5, 2018
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (18); TH (2)