DiphtheriaPhase 3AladdinNCT04618640
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
A Phase 3 study testing DTaP-IPV combination vaccine in people with Diphtheria and Tetanus, run by Boryung Biopharma Co., Ltd. at 26 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP-IPV combination vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 26 sitesSouth Korea
- Study dates
- 26 Dec 2019to 30 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites, 26 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Yun Kyung Kim
- Recruiting
Hallym University Medical Center
Anyang
Han Wool Kim
- Recruiting
Changwon Fatima Hospital
Changwon
Sang Hyuk Ma
- Recruiting
KeiMyung University Dongsan Medical Center
Daegu
Chun Soo Kim
- Recruiting
Hallym University Medical Center
Gyeonggi-do
Seon Hee Shin
- Recruiting
Myongji Hospital
Gyeonggi-do
Kwang Nam Kim
- Recruiting
Wonkwang University Hospital
Iksan
Seung Taek Yu
- Recruiting
Inha University Hospital
Incheon
Yong Hoon Jun
- Recruiting
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon
Ki Hwan Kim
- Recruiting
Jeonbuk National University Hospital
Jeonju
Dae Sun Jo
- Recruiting
Mediplex Sejong Hospital
Sejong
Kyu Yol Rhie
- Recruiting
Bundang Cha Hospital
Seongnam
Taek Jin Lee
- Recruiting
Asan Medical Center
Seoul
Jin A Lee
- Recruiting
Chung-Ang University Hospital
Seoul
Sin Weon Yun
- Recruiting
Eulji University Hospital
Seoul
Byeong Uk Eun
- Recruiting
Gangnam Sevrance Christian Hospital
Seoul
Ji Hong Kim
- Recruiting
Hanil General Hospital
Seoul
Jin Lee
- Recruiting
Kangdong Sacred Heart Hospital
Seoul
Ji Hye kim
- Recruiting
Korea Cancer Center Hospital
Seoul
Dong Ho Kim
- Recruiting
KyungHee University Hospital at Gangdong
Seoul
Sung Hoon Chung
- Recruiting
KyungHee University Hospital
Seoul
Eun Hye Lee
- Recruiting
Samsung Medical Center
Seoul
Yae Jean Kim
- Recruiting
Severance Hospital
Seoul
Jong Gyun Ahn
- Recruiting
Ajou University Hospital
Suwon
Hyun Joo Jung
- Recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon
Jong Hyun Kim
- Recruiting
Wonju Sevrance Christian Hospital
Wŏnju
Hwang Min Kim
About this study
Official title: 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
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.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Being tested
- DTaP-IPV combination vaccine
- Keywords
- DTaP-IPV, Boosting Dose
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV combination vaccineBiological
Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years
| Study group | Role | What they receive |
|---|---|---|
| DTaP-IPV combination vaccine | Experimental | DTaP-IPV 0.5ml IM boosting Receives: Biological: DTaP-IPV combination vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate after boosting vaccination
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Measured: 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
Seroprotection rate
Measured: Day 1 Pre-vaccination
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
Seroprotection rate (≥ 0.01 IU/mL)
Measured: Day 1 Pre-vaccination
Pre-booster antibody level
Measured: Day 1 Pre-vaccination
Post-booster antibody level
Measured: boosting vaccination after Day 28 [+14 days]
Geometric mean ratio (GMR) between the pre- and post-booster antibody level
Measured: 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)
Measured: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
Reverse cumulative distribution curves for pre- and post-booster antibody level
Measured: 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
Measured: 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
Measured: boosting vaccination after Day 28 [+14 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start26 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- DTaP-IPV combined vaccine, 0.5mL, imtramuscular
- Masking
- None (open label)
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byeonguk Eun, Study chair, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618640
- Sponsor's protocol ID
- BR-DTPP-CT-302
- Acronym
- Aladdin
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04618640
- Acronym / sponsor ID
- Aladdin / BR-DTPP-CT-302
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Keywords
- DTaP-IPV, Boosting Dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Boryung Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- DTaP-IPV combined vaccine, 0.5mL, imtramuscular
| Arm | Type | Receives |
|---|---|---|
| DTaP-IPV combination vaccine | Experimental | Biological: DTaP-IPV combination vaccineDTaP-IPV 0.5ml IM boosting |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTaP-IPV combination vaccineDosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years | Biological | DTaP-IPV combination vaccine |
Primary outcome
Seroconversion rate after boosting vaccination
Time frame: boosting vaccination after Day 28 [+14 days]
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
9 secondary outcomes
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
Time frame: Day 1 Pre-vaccination
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
Time frame: Day 1 Pre-vaccination
Pre-booster antibody level
Time frame: Day 1 Pre-vaccination
Post-booster antibody level
Time frame: boosting vaccination after Day 28 [+14 days]
Geometric mean ratio (GMR) between the pre- and post-booster antibody level
Time frame: 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)
Time frame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
Reverse cumulative distribution curves for pre- and post-booster antibody level
Time frame: 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
Time frame: 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
Time frame: boosting vaccination after Day 28 [+14 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byeonguk Eun study chair
Eulji University Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTaP-IPV combination vaccine in people with Diphtheria and Tetanus, run by Boryung Biopharma Co., Ltd. at 26 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunhye IM (+82-2-780-8454, Imsunhye@boryungbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate after boosting vaccination (time frame: boosting vaccination after Day 28 [+14 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.