To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
Aladdin
A Multicenter, Single-group, Phase III Study to Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Who Completed the Primary Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis by Participating in the Phase III Study, BR-DTPP-CT-301, or by Receiving Routine Vaccination
1 other identifier
interventional
249
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2019
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2019
CompletedFirst Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedNovember 6, 2020
November 1, 2020
1 year
November 1, 2020
November 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate after boosting vaccination
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
boosting vaccination after Day 28 [+14 days]
Secondary Outcomes (9)
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
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
Day 1 Pre-vaccination
Pre-booster antibody level
Day 1 Pre-vaccination
Post-booster antibody level
boosting vaccination after Day 28 [+14 days]
Geometric mean ratio (GMR) between the pre- and post-booster antibody level
Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
- +4 more secondary outcomes
Study Arms (1)
DTaP-IPV combination vaccine
EXPERIMENTALDTaP-IPV 0.5ml IM boosting
Interventions
Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Byeonguk Eun
Eulji University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 6, 2020
Study Start
December 26, 2019
Primary Completion
December 31, 2020
Study Completion
July 30, 2021
Last Updated
November 6, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share