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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


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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