Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Virosomal influenza vaccine (AdImmune HA Antigen)
Virosomal influenza vaccine (CSL HA Antigen)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Virus, Vaccination, Immunisation
Eligibility 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
Sites / Locations
- Covance Clinical Research Unit AG
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Group A - Young adults
Group B - Young adults
Group C - Elderly
Group D - Elderly
Arm Description
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Outcomes
Primary Outcome Measures
Geometric Mean Titer
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01412281
Brief Title
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Virus, Vaccination, Immunisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - Young adults
Arm Type
Experimental
Arm Description
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Arm Title
Group B - Young adults
Arm Type
Active Comparator
Arm Description
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Arm Title
Group C - Elderly
Arm Type
Experimental
Arm Description
1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012
Arm Title
Group D - Elderly
Arm Type
Active Comparator
Arm Description
1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
Intervention Type
Biological
Intervention Name(s)
Virosomal influenza vaccine (AdImmune HA Antigen)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Virosomal influenza vaccine (CSL HA Antigen)
Intervention Description
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
Primary Outcome Measure Information:
Title
Geometric Mean Titer
Description
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)
Time Frame
3 weeks after vaccination (Day 22 ± 2 days)
Title
Seroprotection
Description
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)
Time Frame
3 weeks after vaccination (Day 22 ± 2 days)
Title
Seroconversion
Description
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)
Time Frame
3 weeks after vaccination (Day 22 ± 2 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Description
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
Time Frame
Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Seiberling, MD
Organizational Affiliation
Covance Clinical Research Unit AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Research Unit AG
City
Allschwil
ZIP/Postal Code
4123
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
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