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

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 Overview

• Status: Unknown
• Conditions: Pertussis; Tetanus; Diphtheria; Poliomyelitis
• Intervention / Treatment: Biological: DTaP-IPV combination vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 249
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sunhye IM; Phone Number: +82-2-780-8454; Email: Imsunhye@boryungbio.co.kr
• Study Contact Backup: Name: Seohee Byeon; Phone Number: +82-2-740-4154; Email: seohee@boryungbio.co.kr

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Recruiting
    • Korea University Ansan Hospital
    • Principal Investigator: Yun Kyung Kim
  • Anyang, Korea, Republic of
    • Recruiting
    • Hallym University Medical Center
    • Principal Investigator: Han Wool Kim
  • Changwon, Korea, Republic of
    • Recruiting
    • Changwon Fatima Hospital
    • Principal Investigator: Sang Hyuk Ma
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Chun Soo Kim
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Hallym University Medical Center
    • Principal Investigator: Seon Hee Shin
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Myongji Hospital
    • Principal Investigator: Kwang Nam Kim
  • Iksan, Korea, Republic of
    • Recruiting
    • Wonkwang University Hospital
    • Principal Investigator: Seung Taek Yu
  • Incheon, Korea, Republic of
    • Recruiting
    • Inha University Hospital
    • Principal Investigator: Yong Hoon Jun
  • Incheon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Incheon St. Mary's Hospital
    • Principal Investigator: Ki Hwan Kim
  • Jeonju, Korea, Republic of
    • Recruiting
    • Jeonbuk National University Hospital
    • Principal Investigator: Dae Sun Jo
  • Sejong, Korea, Republic of
    • Recruiting
    • Mediplex Sejong Hospital
    • Principal Investigator: Kyu Yol Rhie
  • Seongnam, Korea, Republic of
    • Recruiting
    • Bundang CHA Hospital
    • Principal Investigator: Taek Jin Lee
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: Jin A Lee
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Principal Investigator: Jong Gyun Ahn
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Yae Jean Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangdong Sacred Heart Hospital
    • Principal Investigator: Ji Hye kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-ang University Hospital
    • Principal Investigator: Sin Weon Yun
  • Seoul, Korea, Republic of
    • Recruiting
    • Eulji University Hospital
    • Principal Investigator: Byeong Uk Eun
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Sevrance Christian Hospital
    • Principal Investigator: Ji Hong Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanil General Hospital
    • Principal Investigator: Jin Lee
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea Cancer Center Hospital
    • Principal Investigator: Dong Ho Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyunghee University Hospital at Gangdong
    • Principal Investigator: Sung Hoon Chung
  • Seoul, Korea, Republic of
    • Recruiting
    • KyungHee University Hospital
    • Principal Investigator: Eun Hye Lee
  • Suwon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea St. Vincent's Hospital
    • Principal Investigator: Jong Hyun Kim
  • Suwon, Korea, Republic of
    • Recruiting
    • Ajou University Hospital
    • Principal Investigator: Hyun Joo Jung
  • Wonju, Korea, Republic of
    • Recruiting
    • Wonju Sevrance Christian Hospital
    • Principal Investigator: Hwang Min Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate after boosting vaccination	Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).	boosting vaccination after Day 28 [+14 days]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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]
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]
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]

Collaborators and Investigators

• Sponsor: Boryung Biopharma Co., Ltd.
• Investigators: Study Chair: Byeonguk Eun, Eulji University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: DTaP-IPV; Boosting Dose
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neuromuscular Diseases; Central Nervous System Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Clostridium Infections; Corynebacterium Infections; Myelitis; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
• Other Study ID Numbers: BR-DTPP-CT-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No