Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|
| Virosomal influenza vaccine | Biological | Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine |
|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Milko Radicioni, MD | CROSS-Research SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS-Research SA | Arzo | 6864 | Switzerland |
Not provided
Recruitment period: 03 August 2012 to 27 August 2012; outpatient study
Not provided
| 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 |
|
Not provided
Not provided
| 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 |
|
Not provided
Not provided
Not provided
| 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | info@crucell.com |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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, 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 |
| 23 |
| 55 |
| EG001 | Adults From 18 to 60 Years Old Inclusive | 0 | 55 | 32 | 55 |
| 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 |
|
| Chills (shivering) | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system 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 |
|
| Rash | Skin and subcutaneous tissue 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 |
| Solicited local AEs |
|
| Solicited systemic AEs |
|
| Percentage seroconverted subjects: B strain |
|
| GMT fold increase: B strain |
|