Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01306253
First received: February 28, 2011
Last updated: August 29, 2013
Last verified: August 2013

February 28, 2011
August 29, 2013
June 2009
June 2009   (final data collection date for primary outcome measure)
  • 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
Immunogenicity, assessed by the haemagglutination inhibition (HI) test [ Time Frame: 3 weeks post-vaccination ] [ Designated as safety issue: No ]

Immunogenicity parameters were:

  • Seroconversion rate: defined as ≥4-fold increase in HI antibody titer and a titer of ≥1:40 to be reached in >40% of subjects aged ≥18 to ≤60 years and in >30% of subjects aged >60 years
  • Seroprotection rate: defined as HI antibody titer ≥1:40 to be reached in >70% of subjects aged ≥18 to ≤60 years and in >60% of subjects aged >60 years
  • Geometric mean titer (GMT): a >2.5-fold increase in GMT of HI antibodies in subjects aged ≥18 to ≤60 years and a >2.0-fold increase in GMT of HI antibodies in subjects aged >60 years has to be reached
Complete list of historical versions of study NCT01306253 on ClinicalTrials.gov Archive Site
  • Safety: Numbers of Subjects Reporting Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ] [ Designated as safety issue: Yes ]
    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
  • Numbers of Subjects Reporting Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ] [ Designated as safety issue: Yes ]
    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
Safety: incidence of solicited and unsolicited adverse events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere
Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Influenza
Biological: Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 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/Brisbane/60/2008-like virus

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

  • Experimental: Elderly
    Elderly subjects aged over 60 years
    Intervention: Biological: Inflexal V
  • Experimental: Adults
    Adults from 18 to 60 years old inclusive
    Intervention: Biological: Inflexal V
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
June 2009
June 2009   (final data collection date for primary outcome measure)

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, 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01306253
INF-V-A003
No
Crucell Holland BV
Crucell Holland BV
Not Provided
Principal Investigator: Michael Seiberling, MD Covance Clinical Research Unit AG
Crucell Holland BV
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP