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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011450-18 | EudraCT Number |
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The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults | Experimental | Healthy volunteers aged 18 to 59 years |
|
| Older Adults | Experimental | Healthy volunteers aged 60 years or older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Influenza Vaccine (2009 / 2010 formulation) | Biological | A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10. | Approximately 21 days after vaccination |
| The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre. | Approximately 21 days after vaccination |
| The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | Approximately 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The Frequency of Any Solicited Local Reactions. | The number of participants reporting any solicited local reactions. | During the 4 days after vaccination (Day 0 plus 3 days) |
| The Frequency of Any Solicited Systemic Symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Director Vaccines | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School | Dundee | DD1 9SY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults | Healthy volunteers aged 18 to 59 years |
| FG001 | Older Adults | Healthy volunteers aged 60 years or older |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults | Healthy volunteers aged 18 to 59 years |
| BG001 | Older Adults | Healthy volunteers aged 60 years or older |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10. | The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2). | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 21 days after vaccination |
|
Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
The Safety Population comprised all participants who received study vaccine.
Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.
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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 | Adults | Healthy volunteers aged 18 to 59 years |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site mass | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | Seqirus | 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
The number of participants reporting any solicited systemic symptoms.
| During the 4 days after vaccination (Day 0 plus 3 days) |
| The Incidence of Any Unsolicited Adverse Events (AEs). | The number of participants reporting any unsolicited adverse events. Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities. | After vaccination until the end of the study; approximately 21 days |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Adults |
Healthy volunteers aged 18 to 59 years |
| OG001 | Older Adults | Healthy volunteers aged 60 years or older |
|
|
| Primary | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre. | The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2). | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 21 days after vaccination |
|
|
|
| Primary | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2). | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 21 days after vaccination |
|
|
|
| Secondary | The Frequency of Any Solicited Local Reactions. | The number of participants reporting any solicited local reactions. | The Safety Population comprised all participants who received study vaccine. | Posted | Number | participants | During the 4 days after vaccination (Day 0 plus 3 days) |
|
|
|
| Secondary | The Frequency of Any Solicited Systemic Symptoms. | The number of participants reporting any solicited systemic symptoms. | The Safety Population comprised all participants who received study vaccine. | Posted | Number | participants | During the 4 days after vaccination (Day 0 plus 3 days) |
|
|
|
| Secondary | The Incidence of Any Unsolicited Adverse Events (AEs). | The number of participants reporting any unsolicited adverse events. Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities. | The Safety Population comprised all participants who received study vaccine. | Posted | Number | participants | After vaccination until the end of the study; approximately 21 days |
|
|
|
| 0 |
| 60 |
| 14 |
| 60 |
| EG001 | Older Adults | Healthy volunteers aged 60 years or older | 0 | 60 | 11 | 60 |
| Injection site erythema | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B/Brisbane/60/2008 - like strain |
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| B/Brisbane/60/2008 - like strain |
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| Any erythema |
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| Any pain |
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| Any ecchymosis |
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| Any chills |
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| Any malaise |
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| Number of participants reporting moderate UAE |
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| Number of participants reporting severe UAE |
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