Back to resultsA Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Inflexal V
Sponsored by
About this trial
This is an interventional treatment trial for Influenza focused on measuring Influenza, Virus, Vaccination, Immunisation
Eligibility Criteria
Inclusion criteria:
- Healthy female and male adults
- Aged ≥18 to ≤60 years or >60 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 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 study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; 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 relative or spouse of the investigator
- Suspected non-compliance
Sites / Locations
- Covance Clinical Research Unit AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Adults from 18 to 60 years old inclusive
Elderly subjects aged over 60 years
Outcomes
Primary Outcome Measures
Seroconversion
Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Seroprotection
Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40
Fold Increase in Geometric Mean Titer (GMT)
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Secondary Outcome Measures
Safety: Incidence of Solicited Local Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Incidence of Solicited Systemic Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01303510
Brief Title
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
Official Title
Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2008/2009-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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
A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
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
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Adults from 18 to 60 years old inclusive
Arm Title
Group B
Arm Type
Experimental
Arm Description
Elderly subjects aged over 60 years
Intervention Type
Biological
Intervention Name(s)
Inflexal V
Intervention Description
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:
15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
15 µg HA antigen of B/Florida/4/2006-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Primary Outcome Measure Information:
Title
Seroconversion
Description
Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Time Frame
Day 22 ± 2 days
Title
Seroprotection
Description
Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40
Time Frame
Day 22 ± 2 days
Title
Fold Increase in Geometric Mean Titer (GMT)
Description
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time Frame
Day 22/Day 1
Secondary Outcome Measure Information:
Title
Safety: Incidence of Solicited Local Adverse Events
Description
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Time Frame
Days 1 to 4 inclusive, and Day 22
Title
Incidence of Solicited Systemic Adverse Events
Description
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Time Frame
Days 1 to 4 inclusive, and Day 22
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 to ≤60 years or >60 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 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 study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; 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 relative or spouse of 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
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
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