To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
NCT ID: NCT04618640
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
249 participants
INTERVENTIONAL
2019-12-26
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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DTaP-IPV combination vaccine
DTaP-IPV 0.5ml IM boosting
DTaP-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
Interventions
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DTaP-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
Eligibility Criteria
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Inclusion Criteria
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
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
4 Years
6 Years
ALL
Yes
Sponsors
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Boryung Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Byeonguk Eun
Role: STUDY_CHAIR
Eulji University Hospital
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Hallym University Medical Center
Anyang, , South Korea
Changwon Fatima Hospital
Changwon, , South Korea
KeiMyung University Dongsan Medical Center
Daegu, , South Korea
Hallym University Medical Center
Gyeonggi-do, , South Korea
Myongji Hospital
Gyeonggi-do, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Inha University Hospital
Incheon, , South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Mediplex Sejong Hospital
Sejong, , South Korea
Bundang Cha Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Eulji University Hospital
Seoul, , South Korea
Gangnam Sevrance Christian Hospital
Seoul, , South Korea
Hanil General Hospital
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
KyungHee University Hospital at Gangdong
Seoul, , South Korea
KyungHee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Wonju Sevrance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Other Identifiers
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BR-DTPP-CT-302
Identifier Type: -
Identifier Source: org_study_id