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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001101-24 | EudraCT Number |
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This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults | Experimental | Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
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| Older Adults | Experimental | Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL Influenza Vaccine | Biological | The study vaccine (CSL Influenza Vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection. |
| 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 (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was 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 (H1N1, H3N2, and B influenza virus strains) was 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. | For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected. | Approximately 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Intensity of Any Solicited Adverse Events (AEs). | The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only. Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site. Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise. Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities. |
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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 |
|---|---|---|---|---|---|---|
| Study Site | London | NW10 7EW | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults | Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
| FG001 | Older Adults | Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults | Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
| BG001 | Older Adults | Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
| 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 (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was 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 included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 21 days after vaccination |
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For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days).
The other AEs presented include solicited and unsolicited AEs.
The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.
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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 received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | 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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|
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| During the 4 days after vaccination (Day 0 plus 3 days) |
| Frequency of Any Unsolicited AEs. | The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited. | 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 |
|
| OG000 |
| Adults |
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
| OG001 | Older Adults | Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. |
|
|
| Primary | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre. | The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria. | Posted | Geometric Mean | 95% Confidence Interval | geometric mean 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. | For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected. | The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 21 days after vaccination |
|
|
|
| Secondary | Frequency and Intensity of Any Solicited Adverse Events (AEs). | The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only. Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site. Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise. Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities. | The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | During the 4 days after vaccination (Day 0 plus 3 days) |
|
|
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| Secondary | Frequency of Any Unsolicited AEs. | The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited. | The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | After vaccination until the end of the study; approximately 21 days |
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|
| 0 |
| 60 |
| 36 |
| 60 |
| EG001 | Older Adults | Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection. | 0 | 60 | 18 | 60 |
| Erythema | General disorders | Systematic Assessment |
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| Ecchymosis | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-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 strain |
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| B strain |
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| Erythema |
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| Ecchymosis |
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| Pain |
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| Any solicited systemic AE |
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| Temperature > 38°C for ≥ 24 hours |
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| Severe temperature (> 40°C) |
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| Chills |
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| Malaise |
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