Post Marketing Surveillance for ADACEL™ in South Korea

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137435
• Other study ID #: Td533
• Secondary ID: UTN: U1111-1112-
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: September 2016

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
0.5 mL, intramuscular (IM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™	Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.	30 days post-vaccination
Other	Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™	All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.	30 days post-vaccination
Other	Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™	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.	7 days post-vaccination
Primary	Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™	All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.	30 days post-vaccination

External Links

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