Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	211
Study Start Date:	February 2010
Study Completion Date:	July 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaccination Single 0.5 mL intramuscular injection of PreFluCel 2009/2010	Biological: Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures) Single 0.5 mL intramuscular injection Other Name: PreFluCel 2009/2010

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.
If female, subject is pregnant or lactating at the time of study enrollment
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063088

Locations

Austria
Sanatorium Leech
Graz, Austria, 8010
Belgium
ZU Gent, Centrum voor vaccinologie
Ghent, Belgium, 9000

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Gerald Aichinger, MD

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01063088 History of Changes
Other Study ID Numbers:	720903, 2009-017781-23
Study First Received:	February 4, 2010
Last Updated:	July 8, 2010
Health Authority:	Austria: Agency for Health and Food Safety (AGES) Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Baxter Healthcare Corporation:

Prophylaxis of seasonal influenza in adults

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013