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

Tetanus Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618640
• Other study ID #: BR-DTPP-CT-302
• Status: Recruiting
• Phase: Phase 3
• Start date: December 26, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2020
• Source: Boryung Biopharma Co., Ltd.
• Contact: Sunhye IM
• Phone: +82-2-780-8454
• Email: Imsunhye[@]boryungbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: July 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Hallym University Medical Center	Anyang
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	KeiMyung University Dongsan Medical Center	Daegu
Korea, Republic of	Hallym University Medical Center	Gyeonggi-do
Korea, Republic of	Myongji Hospital	Gyeonggi-do
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Mediplex Sejong Hospital	Sejong
Korea, Republic of	Bundang Cha Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Eulji University Hospital	Seoul
Korea, Republic of	Gangnam Sevrance Christian Hospital	Seoul
Korea, Republic of	Hanil General Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	KyungHee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon
Korea, Republic of	Wonju Sevrance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Biopharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate after boosting vaccination	Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).	boosting vaccination after Day 28 [+14 days]
Secondary	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
Secondary	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
Secondary	Pre-booster antibody level		Day 1 Pre-vaccination
Secondary	Post-booster antibody level		boosting vaccination after Day 28 [+14 days]
Secondary	Geometric mean ratio (GMR) between the pre- and post-booster antibody level		Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
Secondary	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]
Secondary	Reverse cumulative distribution curves for pre- and post-booster antibody level		Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
Secondary	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]
Secondary	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]