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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
249
Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years
Korea University Ansan Hospital
Ansan, South Korea
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]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hallym University Medical Center
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RECRUITING...and 16 more locations
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]