Aladdin: To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

• Sponsor: Boryung Biopharma Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04618640
• Collaborator: (none)
• Enrollment: 249
• Locations: 26
• Arm: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria; Tetanus; Pertussis; Poliomyelitis	Biological: DTaP-IPV combination vaccine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 249 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: DTaP-IPV combined vaccine, 0.5mL, imtramuscularDTaP-IPV combined vaccine, 0.5mL, imtramuscular
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Dec 26, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DTaP-IPV combination vaccine DTaP-IPV 0.5ml IM boosting	Biological: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

3. Pre-booster antibody level [Day 1 Pre-vaccination]

4. Post-booster antibody level [boosting vaccination after Day 28 [+14 days]]

5. Geometric mean ratio (GMR) between the pre- and post-booster antibody level [Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]]

6. 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]]

7. Reverse cumulative distribution curves for pre- and post-booster antibody level [Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]]

8. 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]]

9. 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]]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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

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:

1. Children aged 7 years or older

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Ansan Hospital	Ansan		Korea, Republic of
2	Hallym University Medical Center	Anyang		Korea, Republic of
3	Changwon Fatima Hospital	Changwon		Korea, Republic of
4	KeiMyung University Dongsan Medical Center	Daegu		Korea, Republic of
5	Hallym University Medical Center	Gyeonggi-do		Korea, Republic of
6	Myongji Hospital	Gyeonggi-do		Korea, Republic of
7	Wonkwang University Hospital	Iksan		Korea, Republic of
8	Inha University Hospital	Incheon		Korea, Republic of
9	The Catholic University of Korea Incheon St. Mary's Hospital	Incheon		Korea, Republic of
10	Jeonbuk National University Hospital	Jeonju		Korea, Republic of
11	Mediplex Sejong Hospital	Sejong		Korea, Republic of
12	Bundang Cha Hospital	Seongnam		Korea, Republic of
13	Asan Medical Center	Seoul		Korea, Republic of
14	Chung-Ang University Hospital	Seoul		Korea, Republic of
15	Eulji University Hospital	Seoul		Korea, Republic of
16	Gangnam Sevrance Christian Hospital	Seoul		Korea, Republic of
17	Hanil General Hospital	Seoul		Korea, Republic of
18	Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of
19	Korea Cancer Center Hospital	Seoul		Korea, Republic of
20	KyungHee University Hospital at Gangdong	Seoul		Korea, Republic of
21	KyungHee University Hospital	Seoul		Korea, Republic of
22	Samsung Medical Center	Seoul		Korea, Republic of
23	Severance Hospital	Seoul		Korea, Republic of
24	Ajou University Hospital	Suwon		Korea, Republic of
25	The Catholic University of Korea St. Vincent's Hospital	Suwon		Korea, Republic of
26	Wonju Sevrance Christian Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Boryung Biopharma Co., Ltd.

Investigators

• Study Chair: Byeonguk Eun, Eulji University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boryung Biopharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04618640
• Other Study ID Numbers: BR-DTPP-CT-302
• First Posted: Nov 6, 2020
• Last Update Posted: Nov 6, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Boryung Biopharma Co., Ltd.: DTaP-IPV; Boosting Dose
• Additional relevant MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis

Study Results

No Results Posted as of Nov 6, 2020