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Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

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ClinicalTrials.gov Identifier: NCT01631071
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Condition or disease Intervention/treatment Phase
Influenza Biological: Virosomal influenza vaccine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: 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 2012/2013-Season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Elderly subjects aged over 60 years Biological: Virosomal influenza vaccine
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine
Experimental: Adults from 18 to 60 years old inclusive Biological: Virosomal influenza vaccine
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine



Primary Outcome Measures :
  1. Seroprotection [ Time Frame: Day 22 +/- 2 days ]
    Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  2. Seroconversion [ Time Frame: Day 22 +/- 2 days ]
    Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  3. Geometric Mean Titer [ Time Frame: Day 22 +/- 2 days ]
    GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)


Secondary Outcome Measures :
  1. Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability [ Time Frame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) ]

    Solicited local and systemic AEs, Unsolicited AEs

    Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).

    Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4




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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 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) starting from the first day of the month following the last visit in a previous study
  • 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): NCT01631071


Locations
Switzerland
CROSS-Research SA
Arzo, Switzerland, 6864
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Milko Radicioni, MD CROSS-Research SA

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01631071     History of Changes
Other Study ID Numbers: ADD-V-A003
First Posted: June 28, 2012    Key Record Dates
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013
Last Verified: February 2013

Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Virosomal influenza vaccine

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