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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.
The objectives of this study are to evaluate the humoral immunogenicity and safety of the parenteral formulation of the 2010/2011-season influenza vaccine, Inflexal V, using HA antigen obtained from 2 different production facilities, and to compare the immunogenicity of both formulations to pre-defined EMA criteria for the annual relicensing of seasonal influenza vaccines. The evaluation will be done in young adults and elderly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects ≥18 to ≤60 Years - CSL HA Antigen | Active Comparator | Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group A will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. 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 |
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| Subjects >60 Years - CSL HA Antigen | Active Comparator | Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group B will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. 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 |
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| Subjects ≥18 to ≤60 Years - AdImmune HA Antigen | Experimental | Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group C will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.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 |
|
| Subjects >60 Years - AdImmune HA Antigen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflexal V influenza vaccine (CSL HA Antigen) 2010 | Biological | Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity - Geometric Mean Titer Fold Increase From Baseline | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | 3 weeks after vaccination (Day 22 ± 2 days) |
| Immunogenicity - Seroprotection Rate | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | 3 weeks after vaccination (Day 22 ± 2 days) |
| Immunogenicity - Seroconversion Rate | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | 3 weeks after vaccination (Day 22 ± 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local and Systemic Adverse Events | 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 | Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Seiberling, MD | Covance Clinical Research Unit AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit AG | Allschwil | 4123 | Switzerland | |||
| Cross Research S.A. Phase I Unit |
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Recruitment period: 19 October 2010 to 09 November 2010; outpatient study
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects ≥18 to ≤60 Years - AdImmune HA Antigen | |
| FG001 | Subjects ≥18 to ≤60 Years - CSL HA Antigen | |
| FG002 | Subjects >60 Years - AdImmune HA Antigen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group D will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.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 |
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| Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011 | Biological | Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 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 |
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| Arzo |
| 6864 |
| Switzerland |
| FG003 | Subjects >60 Years - CSL HA Antigen |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects ≥18 to ≤60 Years - AdImmune HA Antigen | |
| BG001 | Subjects ≥18 to ≤60 Years - CSL HA Antigen | |
| BG002 | Subjects >60 Years - AdImmune HA Antigen | |
| BG003 | Subjects >60 Years - CSL HA Antigen | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immunogenicity - Geometric Mean Titer Fold Increase From Baseline | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | GMT fold increase | 3 weeks after vaccination (Day 22 ± 2 days) |
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| Secondary | Number of Participants With Local and Systemic Adverse Events | 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 | Safety population, all vaccinated subjects | Posted | Number | participants | Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) |
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| Primary | Immunogenicity - Seroprotection Rate | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage subjects | 3 weeks after vaccination (Day 22 ± 2 days) |
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| Primary | Immunogenicity - Seroconversion Rate | The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT | Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage subjects | 3 weeks after vaccination (Day 22 ± 2 days) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects ≥18 to ≤60 Years - AdImmune HA Antigen | 0 | 109 | 57 | 109 | |||
| EG001 | Subjects ≥18 to ≤60 Years - CSL HA Antigen | 0 | 111 | 58 | 111 | |||
| EG002 | Subjects >60 Years - AdImmune HA Antigen | 0 | 110 | 25 | 110 | |||
| EG003 | Subjects >60 Years - CSL HA Antigen | 0 | 110 | 30 | 110 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Haemorrhage (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Erythema (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Induration (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain (at the injection site) | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period between 30 to 90 days (depending on the complexitiy of the work) from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | info@crucell.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| GMT fold increase from baseline: A/H3N2 |
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| GMT fold increase from baseline: B-strain |
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