To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
- Conditions
- DiphtheriaPoliomyelitisTetanusPertussis
- Interventions
- Biological: DTaP-IPV combination vaccine
- Registration Number
- NCT04618640
- Lead Sponsor
- Boryung Biopharma Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 249
- 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
- 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)
- 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
- Healthy male or female children, aged 4 to 6 years on the day of the vaccination
- Children aged 7 years or older
- 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
- 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
- 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 DTaP vaccine
- 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
- 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)
- Received immunoglobulins or blood products within 90 days before the study vaccination day or are planned to receive such products during the study period
- Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigational product or bears such a possibility
- Currently enrolled in another clinical trial or planned to participate in another clinical trial
- Any other reasons that preclude the eligibility of the subject, based on investigator's decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DTaP-IPV combination vaccine DTaP-IPV combination vaccine DTaP-IPV 0.5ml IM boosting
- Primary Outcome Measures
Name Time Method Seroconversion rate after boosting vaccination boosting vaccination after Day 28 [+14 days] Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
- Secondary Outcome Measures
Name Time Method Post-booster antibody level boosting vaccination after Day 28 [+14 days] Pre-booster antibody level Day 1 Pre-vaccination Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination Day 1 Pre-vaccination Seroprotection rate (≥ 0.01 IU/mL)
Geometric mean ratio (GMR) between the pre- and post-booster antibody level Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] 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) Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] 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 Day 1 Pre-vaccination Seroprotection rate
Reverse cumulative distribution curves for pre- and post-booster antibody level Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] 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 boosting vaccination after Day 28 [+14 days] Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL boosting vaccination after Day 28 [+14 days]
Trial Locations
- Locations (25)
The Catholic University of Korea Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Bundang Cha Hospital
🇰🇷Seongnam, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
KeiMyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Hallym University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Myongji Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Mediplex Sejong Hospital
🇰🇷Sejong, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Eulji University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Sevrance Christian Hospital
🇰🇷Seoul, Korea, Republic of
Hanil General Hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Wonju Sevrance Christian Hospital
🇰🇷Wonju, Korea, Republic of