Phase 3
N=30
A Study to Assess the Safety of Adacel® Vaccine
Diphtheria · Tetanus · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT01040052 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine — 27; 27; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine |
27; 27; 0; 1; 0; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01040052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.