Yearly Strain Variation Study, 2009/2010

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Seasonal Influenza Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
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, 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 rash or 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 received a seasonal influenza vaccine within 6 months of study entry
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

Treatment and study plan

Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]

Biological

Single intramuscular injection of vaccine

Other names: Preflucel

Primary outcomes

Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination

Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 22, 2009
Registry last updated: Oct 9, 2015

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