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Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

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ClinicalTrials.gov Identifier: NCT01146015
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )

Brief Summary:
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly)

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent influenza subunit vaccine Influvac Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects
Study Start Date : June 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1



Primary Outcome Measures :
  1. HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines [ Time Frame: 2 weeks ]
  2. HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  2. Men and women aged >= 18 and <= 60 years or >= 61 years of age at the day of study vaccination.
  3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria

  1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  2. A serious adverse reaction after a previous (influenza) vaccination.
  3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
  5. A history of Guillain-Barré syndrome or active neurological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146015


Locations
Belgium
Site Reference ID/Investigator# 44974
Tessenderlo, Belgium, 3890
Germany
Site Reference ID/Investigator# 44975
Hamburg, Germany, 22769
Sponsors and Collaborators
Abbott Biologicals
Quintiles, Inc.
Investigators
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V.

Responsible Party: Abbott Biologicals
ClinicalTrials.gov Identifier: NCT01146015     History of Changes
Other Study ID Numbers: S201.3.130
2010-018350-13 ( EudraCT Number )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Biologicals ):
Influenza
Vaccine
CHMP criteria

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs