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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01631071
First received: June 25, 2012
Last updated: December 19, 2013
Last verified: February 2013
  Purpose

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 Intervention
Influenza
Biological: Virosomal influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Seroprotection [ Time Frame: Day 22 +/- 2 days ] [ Designated as safety issue: No ]
    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)

  • Seroconversion [ Time Frame: Day 22 +/- 2 days ] [ Designated as safety issue: No ]
    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)

  • Geometric Mean Titer [ Time Frame: Day 22 +/- 2 days ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: Yes ]

    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



Enrollment: 110
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631071

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

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01631071     History of Changes
Other Study ID Numbers: ADD-V-A003
Study First Received: June 25, 2012
Results First Received: October 25, 2013
Last Updated: December 19, 2013
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on November 25, 2014