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

Last updated: November 1, 2020
Sponsor: Boryung Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Throat And Tonsil Infections

Treatment

N/A

Clinical Study ID

NCT04618640
BR-DTPP-CT-302
  • Ages 4-6
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A subject's parent/legal representative provides a written consent after beinginformed about the study objective, methods, effect of the study vaccine, and otherrelevant 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 clinicalsetting (the primary immunization should have been initiated after 6 weeks of age andat minimal interval of 4 weeks)
  3. Receipt of a boosting dose against diphtheria, tetanus, and pertussis until 2 years ofage; therefore, total of four vaccination records against diphtheria, tetanus, andpertussis and three against polio
  4. Healthy male or female children, aged 4 to 6 years on the day of the vaccination

Exclusion

Exclusion Criteria:

  1. Children aged 7 years or older
  2. Previously received DTaP vaccine five times or more, including the doses received inthe 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 inthe 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 DTaPvaccine
  10. Received a vaccine other than the protocol-permitted vaccines within 28 days from thestudy vaccination day or are planned to receive such a vaccine during the study period
  11. Received systemic corticosteroid treatment at immunosuppressive dosage within 28 daysfrom the study vaccination day or are planned to receive such a treatment during thestudy 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 vaccinationday or are planned to receive such products during the study period
  13. Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigationalproduct or bears such a possibility
  14. Currently enrolled in another clinical trial or planned to participate in anotherclinical trial
  15. Any other reasons that preclude the eligibility of the subject, based oninvestigator's decision

Study Design

Total Participants: 249
Study Start date:
December 26, 2019
Estimated Completion Date:
July 30, 2021

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Medical Center

    Anyang,
    Korea, Republic of

    Active - Recruiting

  • Changwon Fatima Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • KeiMyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Medical Center

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Myongji Hospital

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Wonkwang University Hospital

    Iksan,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Incheon St. Mary's Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Mediplex Sejong Hospital

    Sejong,
    Korea, Republic of

    Active - Recruiting

  • Bundang Cha Hospital

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Eulji University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Gangnam Sevrance Christian Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hanil General Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangdong Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea Cancer Center Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • KyungHee University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • KyungHee University Hospital at Gangdong

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • Wonju Sevrance Christian Hospital

    Wonju,
    Korea, Republic of

    Active - Recruiting

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