Phase 4
N=687
Post Marketing Surveillance for ADACEL™ in South Korea
Diphtheria · Tetanus · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT01137435 ↗Enrolled (actual)
687
Serious AEs
0.2%
Results posted
Jan 2017
Primary outcome: Primary: Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ — 168; 1; 68 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ |
168; 1; 68 | — |
Summary
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.
Eligibility Criteria
Inclusion Criteria
- Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
- Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01137435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.