Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01063088
First received: February 4, 2010
Last updated: July 8, 2010
Last verified: July 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014