An Open Label, Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult Population

Resilience Government Services, Inc.2 sites in 2 countries211 target enrollmentFebruary 2010

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Resilience Government Services, Inc.
Enrollment: 211
Locations: 2
Primary Endpoint: To assess the safety of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population through the first seven post vaccination days
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

July 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Eligibility Criteria

Inclusion Criteria

•Subject is 18 to 59 years of age, inclusive, at the time of screening
•Subject has given written informed consent prior to study entry
•Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
•Subject agrees to keep a daily record of symptoms for the duration of the study
•If female of childbearing potential, subject presents with a negative urine pregnancy test immediately prior to vaccination on Study Day 1 and agrees to employ adequate birth control measures for the duration of the study
•Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria

•Subject has a history of severe allergic reaction or anaphylaxis
•Subject has an oral temperature of \>= 37.5°C on the day of vaccination in this study Subject has a dermatologic condition or tattoos, which may interfere with injection site reaction rating
•Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
•Subject has been vaccinated with seasonal influenza vaccine for the 2009/2010 season
•Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
•Subject has any inherited or acquired immunodeficiency
•Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
•Subject has a functional or surgical asplenia
•Subject has a known or suspected problem with alcohol or drug abuse
•Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.

Outcomes

Primary Outcomes

To assess the safety of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population through the first seven post vaccination days

Time Frame: 7 days