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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DTaP-IPV combination vaccine
DTaP vaccine and IPV vaccine
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

7 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Inje University Busan Paik Hospital
  • KeiMyung University Dongsan Medical Center
  • Gwangmyeong Sungae Hospital
  • Wonkwang University Hospital
  • Inha University Hospital
  • Pusan National University Yangsan Hospital
  • Asan Medical Center
  • Cheil General Hospital
  • Chung-Ang University Hospital
  • Eulgi General Hospital
  • Gangnam Sevrance Christian Hospital
  • Hallym University Medical Center
  • KEPCO Medical Center
  • Korea Cancer Center Hospital
  • KyungHee University Hospital at Gangdong
  • KyungHee University Hospital
  • Samsung Medical Center
  • Wonju Sevrance Christian Hospital
  • Siriraj Hospital
  • Thammasat University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DTaP-IPV combination vaccine

DTaP vaccine and IPV vaccine

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2015
Last Updated
June 25, 2023
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02458183
Brief Title
Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
Acronym
Venus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
May 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DTaP-IPV combination vaccine
Arm Type
Experimental
Arm Description
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
Arm Title
DTaP vaccine and IPV vaccine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV combination vaccine
Intervention Description
0.5-mL IM
Intervention Type
Biological
Intervention Name(s)
DTaP vaccine and IPV vaccine
Other Intervention Name(s)
Boryung DTaP Vaccine Inj. (Prefilled syringe), IPVAX INJ. PREFILLED SYRINGE INJ
Intervention Description
0.5-mL IM
Primary Outcome Measure Information:
Title
Vaccine response rate
Description
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
Time Frame
4 weeks after the three-dose primary vaccination
Secondary Outcome Measure Information:
Title
Geometric mean titer (GMT)
Description
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
Time Frame
4 weeks after the three-dose primary vaccination
Other Pre-specified Outcome Measures:
Title
Solicited adverse event/adverse drug reaction
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
24~26 weeks after the final vaccination
Title
Unsolicited adverse event/adverse drug reaction
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
24~26 weeks after the final vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HJ Jung
Organizational Affiliation
Boryung Pharmaceutical Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
KeiMyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Gwangmyeong Sungae Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Cheil General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eulgi General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Sevrance Christian Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
KEPCO Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Sevrance Christian Hospital
City
Wonju
Country
Korea, Republic of
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Facility Name
Thammasat University
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

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