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A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303510
First Posted: February 24, 2011
Last Update Posted: September 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Crucell Holland BV
  Purpose
A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines

Condition Intervention Phase
Influenza Biological: Inflexal V Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2008/2009-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Seroconversion [ Time Frame: Day 22 ± 2 days ]
    Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40

  • Seroprotection [ Time Frame: Day 22 ± 2 days ]
    Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40

  • Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: Day 22/Day 1 ]
    GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value


Secondary Outcome Measures:
  • Safety: Incidence of Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]
    Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

  • Incidence of Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]
    Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination


Enrollment: 111
Study Start Date: July 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Adults from 18 to 60 years old inclusive
Biological: Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:

  • 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
  • 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
  • 15 µg HA antigen of B/Florida/4/2006-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Experimental: Group B
Elderly subjects aged over 60 years
Biological: Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:

  • 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
  • 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
  • 15 µg HA antigen of B/Florida/4/2006-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1


  Eligibility

Information from the National Library of Medicine

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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:

  • Healthy female and male adults
  • Aged ≥18 to ≤60 years or >60 years on Day 1
  • Written informed consent

Exclusion criteria:

  • Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
  • Acute febrile illness (≥38.0 °C)
  • Prior vaccination with an influenza vaccine in the past 330 days
  • Known hypersensitivity to any vaccine component
  • Previous history of a serious adverse reaction to influenza vaccine
  • History of egg protein allergy or severe atopy
  • Known blood coagulation disorder
  • Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
  • Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
  • Investigational medicinal product received in the past 3 months (90 days)
  • Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
  • Pregnancy or lactation
  • Participation in another clinical trial
  • Employee at the investigational site, or relative or spouse of the investigator
  • Suspected non-compliance
  Contacts and Locations
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): NCT01303510


Locations
Switzerland
Covance Clinical Research Unit AG
Allschwil, Switzerland, 4123
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Michael Seiberling, MD Covance Clinical Research Unit AG
  More Information

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01303510     History of Changes
Other Study ID Numbers: INF-V-A002
First Submitted: February 23, 2011
First Posted: February 24, 2011
Results First Submitted: October 10, 2011
Results First Posted: December 19, 2011
Last Update Posted: September 9, 2013
Last Verified: August 2013

Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Immunisation

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases