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CompletedNCT02458183VenusUpdated Jun 28, 2023

Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS

A Phase 3 interventional study of DTaP-IPV combination vaccine and DTaP vaccine and IPV vaccine in Diphtheria, Tetanus and Pertussis, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 20 sites in 2 countries. Open to participants aged 7 Weeks to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
7 Weeks to 10 Weeks
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
03

Who can participate

Ages eligible
7 Weeks to 10 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
476 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalDTaP-IPV combination vaccine

    0.5-mL IM

  • BiologicalDTaP vaccine and IPV vaccine

    0.5-mL IM

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

05

What researchers measure

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

    Time frame: 4 weeks after the three-dose primary vaccination

Secondary outcomes

  1. 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

    Time frame: 4 weeks after the three-dose primary vaccination

Other outcomes

  1. Solicited adverse event/adverse drug reaction

    Incidence of Treatment-Emergent Adverse Events

    Time frame: 24~26 weeks after the final vaccination

  2. Unsolicited adverse event/adverse drug reaction

    Incidence of Treatment-Emergent Adverse Events

    Time frame: 24~26 weeks after the final vaccination

06

Study locations

20 sites
  • 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
  • Gangnam Sevrance Christian Hospital
    Seoul, Korea, Republic of
  • Hallym University Medical Center
    Seoul, Korea, Republic of
  • KEPCO Medical Center
    Seoul, Korea, Republic of
  • Korea Cancer Center Hospital
    Seoul, Korea, Republic of
  • KyungHee University Hospital at Gangdong
    Seoul, Korea, Republic of
  • KyungHee University Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • Wonju Sevrance Christian Hospital
    Wonju, Korea, Republic of
  • Siriraj Hospital
    Bangkok, Thailand
  • Thammasat University
    Bangkok, Thailand
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02458183
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jun 1, 2015
Start date
Feb 2, 2015
Primary completion
Dec 19, 2017
Completion
May 5, 2018
Last update
Jun 28, 2023

Study contacts

HJ Jung
study director · Boryung Pharmaceutical Co., Ltd

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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