A Study to Assess the Safety of Adacel® Vaccine

Tetanus Clinical Trial

Official title:

A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040052
• Other study ID #: TD532
• Secondary ID: U1111-1111-6093
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2009
• Last updated: January 10, 2014
• Start date: December 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration.

Primary objective:

To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

Description:

Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety.

An additional visit will be conducted 30 days post-vaccination to collect safety information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria :

• Male or female (not pregnant) from 18-45 years of age.

• Healthy, with no current illnesses.

• Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years.

• Women of childbearing age will agree to use birth control during the study.

• In good health, as verified by the following criteria: Heart rate, blood pressure, temperature and health history.

• Able to understand and comply with requirements of the study.

• A voluntary consent form is required before participating in the study.

Exclusion Criteria :

• History of allergy to any ingredient in the vaccine.

• A positive pregnancy test (for women of childbearing age) or women who are breastfeeding.

• Compromised immune system due to treatment of a progressive disease.

• Currently on oral or injected steroids, inhaled high-dosage steroids or other immunodeficiency or toxic drugs.

• History of taking Immunoglobulin or other products during the 3 months prior to participating in the study.

• Received other vaccines during the 4 months prior to participating in the study.

• Has an acute or chronic condition that affects safety (including but not limited to:

chronic liver disease, some kidney pathologies, progressive or unstabilized nerve disorders, diabetes and organ transplants).

• Experienced a severe adverse event after receiving ADACEL® vaccine.

• History of acute illness with temperatures over 37.5ºC during the week before receiving the vaccine.

• Human immunodeficiency virus (HIV) infection.

• History of alcohol or drug addiction during the past 5 years.

• Plans to travel outside of the study area between shots and visits.

• History of Guillain-Barré syndrome.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus

Intervention

Biological:
• Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine	Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).	Days 0-7 Post-vaccination	No

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