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The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly subjects aged over 60 years | Experimental |
| |
| Adults from 18 to 60 years old inclusive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflexal V | Biological | Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Day 22 +/- 2 days |
| 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) | 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 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: 23 July 2012 to 14 August 2012; outpatient study
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderly Subjects Aged Over 60 Years | |
| FG001 | Adults From 18 to 60 Years Old Inclusive |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly Subjects Aged Over 60 Years | |
| BG001 | Adults From 18 to 60 Years Old Inclusive | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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 subjects | 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 | Elderly Subjects Aged Over 60 Years |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | info@crucell.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C475022 | Inflexal V |
| D000954 | Antigens, Surface |
| D022701 | Virosomes |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
| D008567 | Membranes, Artificial |
| D001697 | Biomedical and Dental Materials |
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|
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability | Solicited local and systemic AEs, Unsolicited AEs 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) |
|
|
|
| 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 subjects | Day 22 +/- 2 days |
|
|
|
| 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 | Day 22 +/- 2 days |
|
|
|
| 0 |
| 55 |
| 25 |
| 55 |
| EG001 | Adults From 18 to 60 Years Old Inclusive | 0 | 55 | 35 | 55 |
| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vessel puncture swelling | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Material for public dissemination will be submitted to the sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee.
| D012140 | Respiratory Tract Diseases |
| D004337 |
| Drug Carriers |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D040761 | Biomimetic Materials |
| Solicited local AEs |
|
| Solicited systemic AEs |
|
| Percentage seroconverted subjects: B strain |
|
| GMT fold increase: B strain |
|