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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019532-12 | EudraCT Number |
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The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.
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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 |
|---|---|---|---|---|
| CSL's 2010/2011 Formulation of Enzira® Vaccine | Biological | 45 mcg of HA antigen in 0.5 mL administered by 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 |
|---|---|---|
| Frequency of Any Solicited Adverse Events (AEs) | The number of participants reporting any solicited AEs. | During the 4 days after vaccination (Day 0 plus 3 days) |
| Frequency and Intensity of Any Unsolicited Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Beboso, Dr | Chiltern (Early Phase) Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiltern (Early Phase) Limited | Dundee | Angus and 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, Customized | Number |
| 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.
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 |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | Seqirus | 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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Unsolicited adverse event (UAE) grading:
Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily 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 |
| participants |
|
| 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 | Fold increase | 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 | Frequency of Any Solicited Adverse Events (AEs) | The number of participants reporting any solicited AEs. | The Safety Population comprised all participants who received study vaccine and provided follow-up safety data. | Posted | Number | participants | During the 4 days after vaccination (Day 0 plus 3 days) |
|
|
|
| Secondary | Frequency and Intensity of Any Unsolicited Adverse Events | Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities. | The Safety Population comprised all participants who received study vaccine and provided follow-up safety data. | Posted | Number | participants | After vaccination until the end of the study; approximately 21 days |
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|
|
| 0 |
| 60 |
| 22 |
| 60 |
| EG001 | Older Adults | Healthy volunteers aged 60 years or older | 0 | 60 | 15 | 60 |
| Rhinitis | Infections and infestations | MedDRA 13 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 13 | Systematic Assessment |
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| Vaccination site erythema | General disorders | MedDRA 13 | Systematic Assessment |
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| Vaccination site induration | General disorders | MedDRA 13 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13 | Systematic Assessment |
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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 ecchymosis |
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| Any pain |
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| Any general (systemic) solicited AE |
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| Any temperature above 38 degrees C for ≥ 24 hours |
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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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