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Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)

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.
 
ClinicalTrials.gov Identifier: NCT01893177
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inflexal V Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study Start Date : July 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Elderly subjects aged over 60 years Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
  • Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:
  • • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus
  • • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus
  • • 15 µg HA antigen of B/Massachusetts/2/2012-like virus

Experimental: Adults from 18 to 60 years old inclusive Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
  • Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:
  • • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus
  • • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus
  • • 15 µg HA antigen of B/Massachusetts/2/2012-like virus




Primary Outcome Measures :
  1. Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) [ Time Frame: Day 22 +/- 2 days ]

    Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain:

    • Seroconversion rate at Day 22 has to be >40% of subjects aged ≥18 to ≤60 years and >30% of subjects aged >60 years, or
    • Seroprotection rate at Day 22 has to be >70% of subjects aged ≥18 to ≤60 years and >60% of subjects aged >60 years, or
    • GMT-fold increase at Day 22 compared to baseline: a >2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a >2.0-fold increase has to be reached in subjects aged >60 years


Secondary Outcome Measures :
  1. Incidence of solicited local adverse events [ Time Frame: Days 1 to 4 inclusive ]
  2. Incidence of solicited systemic adverse events [ Time Frame: Days 1 to 4 inclusive ]
  3. Incidence of unsolicited adverse events [ Time Frame: Days 1 to 22 inclusive ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy female and male adults aged ≥18 on Day 1
  • Written informed consent
  • Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

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, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
  • Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
  • 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 of the investigator
  • Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

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): NCT01893177


Locations
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Switzerland
CROSS Research S.A. - Phase I Unit
Arzo, Switzerland, 6864
Sponsors and Collaborators
Crucell Holland BV
Investigators
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Principal Investigator: Milko Radicioni, MD Cross Research S.A.

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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01893177    
Other Study ID Numbers: INF-V-A018
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Inflexal V
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs