A Study to Assess the Safety of Adacel® Vaccine

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.

Completed

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Viet Tri, Phu Tho, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

0.5 mL, Intramuscular

Other names: Adacel®

Primary outcomes

Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine

Time frame: Days 0-7 Post-vaccination

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).

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 25, 2009
Registry last updated: May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed