A Phase 3 interventional study of DTaP-IPV combination vaccine in Diphtheria, Tetanus and Pertussis, sponsored by Boryung Biopharma Co., Ltd.. Status unknown at 26 sites in Korea, Republic of. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Boryung Biopharma Co., Ltd. · Phase 3, Interventional, and Prevention
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.
238 studies on the registry are indexed under Whooping Cough; 14 are open to participants now.
This study's planned enrollment of 249 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Boryung Biopharma Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Seroconversion rate after boosting vaccination
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: 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
Seroprotection rate
Time frame: 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)
Time frame: Day 1 Pre-vaccination
Pre-booster antibody level
Time frame: Day 1 Pre-vaccination
Post-booster antibody level
Time frame: boosting vaccination after Day 28 [+14 days]
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]
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]
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]
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]
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]
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boryung Biopharma Co., Ltd.