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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Young adults | Experimental | 1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 |
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| Group B - Young adults | Active Comparator | 1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012 |
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| Group C - Elderly | Experimental | 1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 |
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| Group D - Elderly | Active Comparator | 1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virosomal influenza vaccine (AdImmune HA Antigen) | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks after vaccination (Day 22 ± 2 days) |
| 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) | 3 weeks after vaccination (Day 22 ± 2 days) |
| 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) | 3 weeks after vaccination (Day 22 ± 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Recruitment period: 06 October 2011 to 10 November 2011; outpatient study
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| ID | Title | Description |
|---|---|---|
| FG000 | ≥18 to ≤60 Years - AdImmune HA Antigen | |
| FG001 | ≥18 to ≤60 Years - CSL HA Antigen | |
| FG002 | >60 Years - AdImmune HA Antigen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Virosomal influenza vaccine (CSL HA Antigen) | Biological | 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 |
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| FG003 | >60 Years - CSL HA Antigen |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ≥18 to ≤60 Years - AdImmune HA Antigen | |
| BG001 | ≥18 to ≤60 Years - CSL HA Antigen | |
| BG002 | >60 Years - AdImmune HA Antigen | |
| BG003 | >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 | 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) | Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | GMT fold increase from baseline | 3 weeks after vaccination (Day 22 ± 2 days) |
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| Primary | 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) | Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage of seroprotected subjects | 3 weeks after vaccination (Day 22 ± 2 days) |
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| Primary | 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) | Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers | Posted | Number | 95% Confidence Interval | percentage of seroconverted subjects | 3 weeks after vaccination (Day 22 ± 2 days) |
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| Secondary | 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 | Safety population, all vaccinated subjects | Posted | Number | participants | Baseline (Day 1) and 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 | ≥18 to ≤60 Years - AdImmune HA Antigen | 0 | 110 | 60 | 110 | |||
| EG001 | ≥18 to ≤60 Years - CSL HA Antigen | 0 | 110 | 52 | 110 | |||
| EG002 | >60 Years - AdImmune HA Antigen | 0 | 110 | 33 | 110 | |||
| EG003 | >60 Years - CSL HA Antigen | 1 | 110 | 29 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoae | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Chills | 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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| Pyrexia | 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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| Rhinitis | Infections and infestations | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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The 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 that is at least 90 days from the time submitted to the sponsor for review. The sponsor can make a reasoned request that publication be delayed for up to 3 months from the date of first submission to the sponsor in order to enable the sponsor to protect proprietary information, Intellectual Property, etc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland | +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: A/H3N2 |
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| GMT fold increase: B-strain |
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