Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS (Venus)

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria; Poliomyelitis
• Intervention / Treatment: Biological: DTaP-IPV combination vaccine; Biological: DTaP vaccine and IPV vaccine

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

• Study Type: Interventional
• Enrollment (Actual): 476
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Gyeonggi-do, Korea, Republic of
    • Gwangmyeong Sungae Hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Hospital
  • Seoul, Korea, Republic of
    • Hallym University Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Hospital at Gangdong
  • Seoul, Korea, Republic of
    • Cheil General Hospital
  • Seoul, Korea, Republic of
    • Eulgi General Hospital
  • Seoul, Korea, Republic of
    • Gangnam Sevrance Christian Hospital
  • Seoul, Korea, Republic of
    • KEPCO Medical Center
  • Wonju, Korea, Republic of
    • Wonju Sevrance Christian Hospital
• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Bangkok, Thailand
    • Thammasat University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DTaP-IPV combination vaccine; 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; 0.5-mL IM
Active Comparator: DTaP vaccine and IPV vaccine; 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; 0.5-mL IM; Other Names: Boryung DTaP Vaccine Inj. (Prefilled syringe); IPVAX INJ. PREFILLED SYRINGE INJ

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited adverse event/adverse drug reaction	Incidence of Treatment-Emergent Adverse Events	24~26 weeks after the final vaccination
Unsolicited adverse event/adverse drug reaction	Incidence of Treatment-Emergent Adverse Events	24~26 weeks after the final vaccination

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Study Director: HJ Jung, Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): May 5, 2018

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimated): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Neuromuscular Diseases; Central Nervous System Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Myelitis; Neuroinflammatory Diseases; Whooping Cough; Tetanus; Diphtheria; Tetany; Poliomyelitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BR-DTPP-CT-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO