At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 132 enrolled
Drug / intervention
TdcP-IPV vaccinebiological
Likely dose
TdcP-IPV vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan
In Brief
A Phase 3 clinical trial evaluating TdcP-IPV vaccine for Diphtheria and 3 related conditions. Completed, enrolled 132 participants across 1 site.
Detailed Summary
The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan. Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Poliomyelitis
CountriesTaiwan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionApr 2009
Study CompletionJul 2009
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.6 years ago
Interventions
TdcP-IPV vaccinebiological
0.5 mL, Intramuscular