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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DTaP-IPV combination vaccine
Sponsored by
Boryung Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring DTaP-IPV, Boosting Dose

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Ansan HospitalRecruiting
  • Hallym University Medical CenterRecruiting
  • Changwon Fatima HospitalRecruiting
  • KeiMyung University Dongsan Medical CenterRecruiting
  • Hallym University Medical CenterRecruiting
  • Myongji HospitalRecruiting
  • Wonkwang University HospitalRecruiting
  • Inha University HospitalRecruiting
  • The Catholic University of Korea Incheon St. Mary's HospitalRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Mediplex Sejong HospitalRecruiting
  • Bundang Cha HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Chung-Ang University HospitalRecruiting
  • Eulji University HospitalRecruiting
  • Gangnam Sevrance Christian HospitalRecruiting
  • Hanil General HospitalRecruiting
  • Kangdong Sacred Heart HospitalRecruiting
  • Korea Cancer Center HospitalRecruiting
  • KyungHee University Hospital at GangdongRecruiting
  • KyungHee University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Severance HospitalRecruiting
  • Ajou University HospitalRecruiting
  • The Catholic University of Korea St. Vincent's HospitalRecruiting
  • Wonju Sevrance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DTaP-IPV combination vaccine

Arm Description

DTaP-IPV 0.5ml IM boosting

Outcomes

Primary Outcome Measures

Seroconversion rate after boosting vaccination
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome Measures

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
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
Seroprotection rate (≥ 0.01 IU/mL)
Pre-booster antibody level
Post-booster antibody level
Geometric mean ratio (GMR) between the pre- and post-booster antibody level
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)
Reverse cumulative distribution curves for pre- and post-booster antibody level
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
Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL

Full Information

First Posted
November 1, 2020
Last Updated
November 1, 2020
Sponsor
Boryung Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04618640
Brief Title
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
Acronym
Aladdin
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis
Keywords
DTaP-IPV, Boosting Dose

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
DTaP-IPV combined vaccine, 0.5mL, imtramuscular
Masking
None (Open Label)
Allocation
N/A
Enrollment
249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DTaP-IPV combination vaccine
Arm Type
Experimental
Arm Description
DTaP-IPV 0.5ml IM boosting
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV combination vaccine
Intervention Description
Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years
Primary Outcome Measure Information:
Title
Seroconversion rate after boosting vaccination
Description
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame
boosting vaccination after Day 28 [+14 days]
Secondary Outcome Measure Information:
Title
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
Description
Seroprotection rate
Time Frame
Day 1 Pre-vaccination
Title
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
Description
Seroprotection rate (≥ 0.01 IU/mL)
Time Frame
Day 1 Pre-vaccination
Title
Pre-booster antibody level
Time Frame
Day 1 Pre-vaccination
Title
Post-booster antibody level
Time Frame
boosting vaccination after Day 28 [+14 days]
Title
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]
Title
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]
Title
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]
Title
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]
Title
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunhye IM
Phone
+82-2-780-8454
Email
Imsunhye@boryungbio.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seohee Byeon
Phone
+82-2-740-4154
Email
seohee@boryungbio.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeonguk Eun
Organizational Affiliation
Eulji University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Kyung Kim
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Wool Kim
Facility Name
Changwon Fatima Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyuk Ma
Facility Name
KeiMyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Soo Kim
Facility Name
Hallym University Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seon Hee Shin
Facility Name
Myongji Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang Nam Kim
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Taek Yu
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Hoon Jun
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Hwan Kim
Facility Name
Jeonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Sun Jo
Facility Name
Mediplex Sejong Hospital
City
Sejong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Yol Rhie
Facility Name
Bundang Cha Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taek Jin Lee
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin A Lee
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sin Weon Yun
Facility Name
Eulji University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong Uk Eun
Facility Name
Gangnam Sevrance Christian Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hong Kim
Facility Name
Hanil General Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Lee
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hye kim
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Ho Kim
Facility Name
KyungHee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hoon Chung
Facility Name
KyungHee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Hye Lee
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yae Jean Kim
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Gyun Ahn
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Jung
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Hyun Kim
Facility Name
Wonju Sevrance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hwang Min Kim

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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