A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01306305
First received: February 28, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

A study to assess whether the Northern Hemisphere 2010/2011 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: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-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 ] [ Designated as safety issue: No ]
    Seroconversion rate was defined as the number 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 ] [ Designated as safety issue: No ]
    Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40

  • Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: Day 22/Day 1 ] [ Designated as safety issue: No ]
    GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value


Secondary Outcome Measures:
  • Safety: Numbers of Subjects Reporting Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Days 8, 15 and 22 ] [ Designated as safety issue: Yes ]
    Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.

  • Numbers of Subjects Reporting Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Days 8, 15 and 22 ] [ Designated as safety issue: Yes ]
    Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.


Enrollment: 110
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly
Elderly subjects aged over 60 years
Biological: Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:

  • 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
  • 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 15 µg HA antigen of B/Brisbane/60/2008-like virus

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

Experimental: Adults
Adults from 18 to 60 years old inclusive
Biological: Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:

  • 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
  • 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 15 µg HA antigen of B/Brisbane/60/2008-like virus

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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306305

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

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01306305     History of Changes
Other Study ID Numbers: INF-V-A004
Study First Received: February 28, 2011
Results First Received: March 1, 2012
Last Updated: August 29, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on April 17, 2014