A Study to Assess the Safety of Adacel® Vaccine

NCT ID: NCT01040052

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-04-30

Brief 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.

Detailed 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.

Conditions

Diphtheria; Tetanus; Pertussis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group

Group Type: EXPERIMENTAL

Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Adacel®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Việt Trì, Phu Tho, Vietnam

Countries

Vietnam

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1111-6093

Identifier Type: OTHER

Identifier Source: secondary_id

TD532

Identifier Type: -

Identifier Source: org_study_id