Post Marketing Surveillance for ADACEL™ in South Korea
This trial is active, not recruiting.
|Conditions||diphtheria, tetanus, pertussis|
|Treatment||adacel™:adsorbed diphtheria, tetanus toxoids and component pertussis combined|
|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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Information concerning reported adverse events following ADACEL™ vaccination.
time frame: 30 days post-vaccination
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 :
|Official title||Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)|
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