A Study to Assess the Safety of Adacel® Vaccine
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01040052
First received: December 21, 2009
Last updated: March 1, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis |
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine [ Time Frame: Days 0-7 Post-vaccination ] [ Designated as safety issue: No ]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).
| Enrollment: | 30 |
| Study Start Date: | December 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Study Group |
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
0.5 mL, Intramuscular
Other Name: Adacel®
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT01040052 History of Changes |
| Other Study ID Numbers: | TD532, U1111-1111-6093 |
| Study First Received: | December 21, 2009 |
| Results First Received: | March 1, 2011 |
| Last Updated: | March 1, 2011 |
| Health Authority: | Vietnam: Ministry of Health |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis Adacel® |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections |
Infection Respiratory Tract Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013