Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01412281
First received: August 8, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.


Condition Intervention Phase
Influenza
Biological: Virosomal influenza vaccine (AdImmune HA Antigen)
Biological: Virosomal influenza vaccine (CSL HA Antigen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Geometric Mean Titer [ Time Frame: 3 weeks after vaccination (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)

  • Seroprotection [ Time Frame: 3 weeks after vaccination (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: 3 weeks after vaccination (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)


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, Tolerability and acceptability

    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: 440
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - Young adults
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Biological: Virosomal influenza vaccine (AdImmune HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg 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
Active Comparator: Group B - Young adults
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Biological: Virosomal influenza vaccine (CSL HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg 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
Experimental: Group C - Elderly
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Biological: Virosomal influenza vaccine (AdImmune HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg 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
Active Comparator: Group D - Elderly
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Biological: Virosomal influenza vaccine (CSL HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg 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

  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 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 (including the H1N1 pandemic swine flu 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 spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
  • Suspected non-compliance
  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: NCT01412281

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: NCT01412281     History of Changes
Other Study ID Numbers: ADD-V-A002
Study First Received: August 8, 2011
Results First Received: October 23, 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 September 14, 2014