Yearly Strain Variation Study, 2010/2011

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01157702
First received: July 6, 2010
Last updated: August 23, 2010
Last verified: August 2010
  Purpose

The purpose of the study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application.


Condition Intervention Phase
Influenza
Seasonal Influenza
Biological: Inactivated influenza vaccine (split virus, Vero cell-derived)
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 Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2010/2011, in an Adult and Elderly Population

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • To assess the immunogenicity to each of the three antigens contained in a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season in an adult and elderly population [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Vaccination with one dose (0.5 mL) of inactivated influenza vaccine
Biological: Inactivated influenza vaccine (split virus, Vero cell-derived)
One 0.5 mL dose of inactivated influenza vaccine in a pre-filled syringe, administered by intramuscular injection into the musculus deltoideus in the upper arm
Other Name: Preflucel

  Eligibility

Ages Eligible for Study:   18 Years and older
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 (for Stratum A only)
  • Subject is 60 years of age or older, inclusive, at the time of screening (for 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 subject is 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 (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
  • Subject is pregnant or lactating at the time of enrollment
  • Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to 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: NCT01157702

Locations
Austria
University Clinic for Clinical Pharmacology, General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Barbara Izay, MD; study medical director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01157702     History of Changes
Other Study ID Numbers: 721001, 2010-020026-17
Study First Received: July 6, 2010
Last Updated: August 23, 2010
Health Authority: Austria: Agency for Health and Food Safety

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 July 20, 2014