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

Boryung Biopharma Co., Ltd.25 sites in 1 country249 target enrollmentDecember 26, 2019

ConditionsDiphtheria Tetanus Pertussis Poliomyelitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Boryung Biopharma Co., Ltd.
Enrollment: 249
Locations: 25
Primary Endpoint: Seroconversion rate after boosting vaccination
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 26, 2019

End Date

July 30, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boryung Biopharma Co., Ltd.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Seroconversion rate after boosting vaccination

Time Frame: boosting vaccination after Day 28 [+14 days]

Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).

Secondary Outcomes

Pre-booster antibody level(Day 1 Pre-vaccination)
Post-booster antibody level(boosting vaccination after Day 28 [+14 days])
Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination(Day 1 Pre-vaccination)
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])
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)
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])