This trial is active, not recruiting.

Conditions diphtheria, tetanus, pertussis
Treatment adacel™:adsorbed diphtheria, tetanus toxoids and component pertussis combined
Phase phase 4
Sponsor Sanofi Pasteur, a Sanofi Company
Start date June 2010
End date March 2016
Trial size 659 participants
Trial identifier NCT01137435, Td533, UTN: U1111-1112-8558


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose prevention
adacel™:adsorbed diphtheria, tetanus toxoids and component pertussis combined Adacel™
0.5 mL, intramuscular (IM)

Primary Outcomes

Information concerning reported adverse events following ADACEL™ vaccination.
time frame: 30 days post-vaccination

Eligibility Criteria

Male or female participants from 11 years up to 64 years old.

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 :

Additional Information

Official title Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Sanofi.