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Completed

NCT Number: NCT01137435

Post Marketing Surveillance for ADACEL™ in South Korea

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.

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

11 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jung-gu, Incheon, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined

Biological

0.5 mL, intramuscular (IM)

Other names: Adacel™

Primary outcomes

  1. Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™

    Time frame: 30 days post-vaccination

    All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.

Other outcomes

  1. Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™

    Time frame: 30 days post-vaccination

    Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.

  2. Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™

    Time frame: 30 days post-vaccination

    All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.

  3. Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™

    Time frame: 7 days post-vaccination

    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.

    All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2010
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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