CClinicalTrials.gg
Status unknownNCT04618640AladdinUpdated Nov 6, 2020

To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

A Phase 3 interventional study of DTaP-IPV combination vaccine in Diphtheria, Tetanus and Pertussis, sponsored by Boryung Biopharma Co., Ltd.. Status unknown at 26 sites in Korea, Republic of. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.

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

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2019, registered Nov 2020).
Phase
Phase 3
Study type
Interventional
Enrollment
249
Allocation
Not applicable
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.

02

Conditions studied

  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis

Keywords

  • DTaP-IPV
  • Boosting Dose
03

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 14 are open to participants now.

This study's planned enrollment of 249 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.

Browse Whooping Cough studies →

Lead sponsor

Boryung Biopharma Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. A subject's parent/legal representative provides a written consent after being informed about the study objective, methods, effect of the study vaccine, and other relevant information
  2. Documented record of the three doses of primary immunization against diphtheria, tetanus, pertussis, and polio either by participating in the previous study, BR-DTPP-CT-301 or by following the national immunization schedule under usual clinical setting (the primary immunization should have been initiated after 6 weeks of age and at minimal interval of 4 weeks)
  3. Receipt of a boosting dose against diphtheria, tetanus, and pertussis until 2 years of age; therefore, total of four vaccination records against diphtheria, tetanus, and pertussis and three against polio
  4. Healthy male or female children, aged 4 to 6 years on the day of the vaccination

Exclusion criteria

Exclusion Criteria:

  1. Children aged 7 years or older
  2. Previously received DTaP vaccine five times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine
  3. Previously received IPV vaccine four times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine
  4. The fourth dose of DTaP vaccine was postponed and administered after 4 years of age
  5. Acute febrile illness with fever ≥ 38.0°C (tympanic) on the day of the vaccination
  6. Moderate to severe systemic acute illness with or without fever
  7. History of diphtheria, tetanus, pertussis, or polio (poliomyelitis)
  8. Dysfunctional immune system or congenital or acquired immunodeficiency
  9. Had encephalopathy of unknown etiology within 7 days following a previous dose of DTaP vaccine
  10. Received a vaccine other than the protocol-permitted vaccines within 28 days from the study vaccination day or are planned to receive such a vaccine during the study period
  11. Received systemic corticosteroid treatment at immunosuppressive dosage within 28 days from the study vaccination day or are planned to receive such a treatment during the study period (exceptionally, administration of prednisolone ≤ 0.5 mg/kg/day for up to 14 continuous days is allowed)
  12. Received immunoglobulins or blood products within 90 days before the study vaccination day or are planned to receive such products during the study period
  13. Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigational product or bears such a possibility
  14. Currently enrolled in another clinical trial or planned to participate in another clinical trial
  15. Any other reasons that preclude the eligibility of the subject, based on investigator's decision
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
249 participants (estimated)

Study arms

  • Experimental
    DTaP-IPV combination vaccine

    DTaP-IPV 0.5ml IM boosting

    Biological: DTaP-IPV combination vaccine

Interventions

  • BiologicalDTaP-IPV combination vaccine

    Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years

06

What researchers measure

Primary outcomes

  1. Seroconversion rate after boosting vaccination

    Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

    Time frame: boosting vaccination after Day 28 [+14 days]

Secondary outcomes

  1. Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA before boosting vaccination

    Seroprotection rate

    Time frame: Day 1 Pre-vaccination

  2. Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination

    Seroprotection rate (≥ 0.01 IU/mL)

    Time frame: Day 1 Pre-vaccination

  3. Pre-booster antibody level

    Time frame: Day 1 Pre-vaccination

  4. Post-booster antibody level

    Time frame: boosting vaccination after Day 28 [+14 days]

  5. Geometric mean ratio (GMR) between the pre- and post-booster antibody level

    Time frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]

  6. GMR between the pre- and post-booster antibody level in each subgroup depending on the pre-booster antibody level (≥ seroprotective/seropositive level or < seroprotective/seropositive level)

    Time frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]

  7. Reverse cumulative distribution curves for pre- and post-booster antibody level

    Time frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]

  8. Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA after boosting vaccination

    Time frame: boosting vaccination after Day 28 [+14 days]

  9. Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL

    Time frame: boosting vaccination after Day 28 [+14 days]

07

Study locations

26 of 26 sites recruiting
  • Korea University Ansan Hospital
    Ansan, Korea, Republic of
    • Yun Kyung Kim · Principal investigator
    Recruiting
  • Hallym University Medical Center
    Anyang, Korea, Republic of
    • Han Wool Kim · Principal investigator
    Recruiting
  • Changwon Fatima Hospital
    Changwon, Korea, Republic of
    • Sang Hyuk Ma · Principal investigator
    Recruiting
  • KeiMyung University Dongsan Medical Center
    Daegu, Korea, Republic of
    • Chun Soo Kim · Principal investigator
    Recruiting
  • Hallym University Medical Center
    Gyeonggi-do, Korea, Republic of
    • Seon Hee Shin · Principal investigator
    Recruiting
  • Myongji Hospital
    Gyeonggi-do, Korea, Republic of
    • Kwang Nam Kim · Principal investigator
    Recruiting
  • Wonkwang University Hospital
    Iksan, Korea, Republic of
    • Seung Taek Yu · Principal investigator
    Recruiting
  • Inha University Hospital
    Incheon, Korea, Republic of
    • Yong Hoon Jun · Principal investigator
    Recruiting
  • The Catholic University of Korea Incheon St. Mary's Hospital
    Incheon, Korea, Republic of
    • Ki Hwan Kim · Principal investigator
    Recruiting
  • Jeonbuk National University Hospital
    Jeonju, Korea, Republic of
    • Dae Sun Jo · Principal investigator
    Recruiting
  • Mediplex Sejong Hospital
    Sejong, Korea, Republic of
    • Kyu Yol Rhie · Principal investigator
    Recruiting
  • Bundang Cha Hospital
    Seongnam, Korea, Republic of
    • Taek Jin Lee · Principal investigator
    Recruiting
  • Asan Medical Center
    Seoul, Korea, Republic of
    • Jin A Lee · Principal investigator
    Recruiting
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
    • Sin Weon Yun · Principal investigator
    Recruiting
  • Eulji University Hospital
    Seoul, Korea, Republic of
    • Byeong Uk Eun · Principal investigator
    Recruiting
  • Gangnam Sevrance Christian Hospital
    Seoul, Korea, Republic of
    • Ji Hong Kim · Principal investigator
    Recruiting
  • Hanil General Hospital
    Seoul, Korea, Republic of
    • Jin Lee · Principal investigator
    Recruiting
  • Kangdong Sacred Heart Hospital
    Seoul, Korea, Republic of
    • Ji Hye kim · Principal investigator
    Recruiting
  • Korea Cancer Center Hospital
    Seoul, Korea, Republic of
    • Dong Ho Kim · Principal investigator
    Recruiting
  • KyungHee University Hospital at Gangdong
    Seoul, Korea, Republic of
    • Sung Hoon Chung · Principal investigator
    Recruiting
  • KyungHee University Hospital
    Seoul, Korea, Republic of
    • Eun Hye Lee · Principal investigator
    Recruiting
  • Samsung Medical Center
    Seoul, Korea, Republic of
    • Yae Jean Kim · Principal investigator
    Recruiting
  • Severance Hospital
    Seoul, Korea, Republic of
    • Jong Gyun Ahn · Principal investigator
    Recruiting
  • Ajou University Hospital
    Suwon, Korea, Republic of
    • Hyun Joo Jung · Principal investigator
    Recruiting
  • The Catholic University of Korea St. Vincent's Hospital
    Suwon, Korea, Republic of
    • Jong Hyun Kim · Principal investigator
    Recruiting
  • Wonju Sevrance Christian Hospital
    Wonju, Korea, Republic of
    • Hwang Min Kim · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04618640
Lead sponsor
Boryung Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Nov 6, 2020
Start date
Dec 26, 2019
Primary completion
Dec 31, 2020 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Nov 6, 2020

Study contacts

Sunhye IM
Contact
Imsunhye@boryungbio.co.kr
+82-2-780-8454
Seohee Byeon
Contact
seohee@boryungbio.co.kr
+82-2-740-4154
Byeonguk Eun
study chair · Eulji University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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