Back to resultsA Study to Assess the Safety of Adacel® Vaccine
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01040052
First Posted
December 21, 2009
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01040052
Brief Title
A Study to Assess the Safety of Adacel® Vaccine
Official Title
A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis
Keywords
Diphtheria, Tetanus, Pertussis, Adacel®
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Other Intervention Name(s)
Adacel®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Description
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).
Time Frame
Days 0-7 Post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Viet Tri
State/Province
Phu Tho Province
Country
Vietnam
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
A Study to Assess the Safety of Adacel® Vaccine
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