Phase
Condition
Throat And Tonsil Infections
Treatment
N/AClinical Study ID
Ages 4-6 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
- 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)
- 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
- Healthy male or female children, aged 4 to 6 years on the day of the vaccination
Exclusion
Exclusion Criteria:
- Children aged 7 years or older
- 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
- 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
- The fourth dose of DTaP vaccine was postponed and administered after 4 years of age
- Acute febrile illness with fever ≥ 38.0°C (tympanic) on the day of the vaccination
- Moderate to severe systemic acute illness with or without fever
- History of diphtheria, tetanus, pertussis, or polio (poliomyelitis)
- Dysfunctional immune system or congenital or acquired immunodeficiency
- Had encephalopathy of unknown etiology within 7 days following a previous dose of DTaPvaccine
- 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
- 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)
- Received immunoglobulins or blood products within 90 days before the study vaccinationday or are planned to receive such products during the study period
- Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigationalproduct or bears such a possibility
- Currently enrolled in another clinical trial or planned to participate in anotherclinical trial
- Any other reasons that preclude the eligibility of the subject, based oninvestigator's decision
Study Design
Connect with a study center
Korea University Ansan Hospital
Ansan,
Korea, Republic ofActive - Recruiting
Hallym University Medical Center
Anyang,
Korea, Republic ofActive - Recruiting
Changwon Fatima Hospital
Changwon,
Korea, Republic ofActive - Recruiting
KeiMyung University Dongsan Medical Center
Daegu,
Korea, Republic ofActive - Recruiting
Hallym University Medical Center
Gyeonggi-do,
Korea, Republic ofActive - Recruiting
Myongji Hospital
Gyeonggi-do,
Korea, Republic ofActive - Recruiting
Wonkwang University Hospital
Iksan,
Korea, Republic ofActive - Recruiting
Inha University Hospital
Incheon,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon,
Korea, Republic ofActive - Recruiting
Jeonbuk National University Hospital
Jeonju,
Korea, Republic ofActive - Recruiting
Mediplex Sejong Hospital
Sejong,
Korea, Republic ofActive - Recruiting
Bundang Cha Hospital
Seongnam,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Chung-Ang University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Eulji University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Gangnam Sevrance Christian Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Hanil General Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Kangdong Sacred Heart Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Korea Cancer Center Hospital
Seoul,
Korea, Republic ofActive - Recruiting
KyungHee University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
KyungHee University Hospital at Gangdong
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon,
Korea, Republic ofActive - Recruiting
Wonju Sevrance Christian Hospital
Wonju,
Korea, Republic ofActive - Recruiting
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