CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
Diphteria, tetanus, and Acellular Pertussis vaccinebiological
Likely dose
ADACEL™ 0.5 mL intramuscularAI-extracted
Key inclusion· 4
  • ✓Aged 6 to 8 years at enrollment
  • ✓Written documentation of complete primary series and fourth dose of DTP vaccine
  • ✓Able to attend all scheduled visits and comply with trial procedures
  • ✓Informed consent signed by parent(s)/legal representative
Key exclusion· 17
  • ✕Immunodeficiency or immunosuppressive therapy (chemotherapy, radiation, or long-term systemic corticosteroids) within 6 months
  • ✕Hypersensitivity to vaccine components or life-threatening reaction to DTP/DTaP vaccine
  • ✕Encephalopathy within 7 days of previous DTP/DTaP dose
  • ✕Fever >40.5°C within 48 hours of previous DTP/DTaP dose not due to another cause

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00258908
NCT00258908Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 28, 2005·Updated Apr 14, 2016

In Brief

A Phase 3 clinical trial evaluating Diphteria, tetanus, and Acellular Pertussis vaccine for Diphtheria and 2 related conditions. Completed, enrolled 115 participants across 1 site.

Detailed Summary

To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration. To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis
CountriesTaiwan
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2005
Enrollment StartNov 1, 2005
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.6 years ago

Interventions

Diphteria, tetanus, and Acellular Pertussis vaccinebiological

0.5 mL, Intramuscular