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Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

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Sanofi

Status

Completed

Conditions

Pertussis

Treatments

Biological: Tetanus Toxoid, acellular pertussis, diphtheria toxoid

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Full description

Surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a large population.

No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care.

Enrollment

327,293 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Receipt of ADACEL vaccine during the study period

Exclusion criteria

  • None

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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