Clinical trial NCT04618640: To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Keywords: DTaP-IPV
Boosting Dose
Lead sponsor: Boryung Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 249
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: DTaP-IPV combined vaccine, 0.5mL, imtramuscular
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion rate after boosting vaccination
timeFrame: boosting vaccination after Day 28 [+14 days]
Secondary outcomes:
measure: 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
timeFrame: Day 1 Pre-vaccination
measure: Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination
timeFrame: Day 1 Pre-vaccination
measure: Pre-booster antibody level
timeFrame: Day 1 Pre-vaccination
measure: Post-booster antibody level
timeFrame: boosting vaccination after Day 28 [+14 days]
measure: Geometric mean ratio (GMR) between the pre- and post-booster antibody level
timeFrame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
measure: 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)
timeFrame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
measure: Reverse cumulative distribution curves for pre- and post-booster antibody level
timeFrame: Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days]
measure: 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
timeFrame: boosting vaccination after Day 28 [+14 days]
measure: Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL
timeFrame: boosting vaccination after Day 28 [+14 days]
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: KeiMyung University Dongsan Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Sejong
country: Korea, Republic of
facility: Mediplex Sejong Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang Cha Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Sevrance Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Hanil General Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Sevrance Christian Hospital
Study officials:
affiliation: Eulji University Hospital
name: Byeonguk Eun
role: STUDY_CHAIR
References: