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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000945-37 | EudraCT Number |
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This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults (aged 18 to 59 years) | Experimental | The study vaccine (Enzira® 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 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection. |
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| Older Adults (aged 60 years or older) | Experimental | The study vaccine (Enzira® 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 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzira® vaccine | Biological |
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| 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) is 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) 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 (H1N1, H3N2, and B influenza virus strains) 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. | 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 of Any Solicited Adverse Events (AEs) | The percentage of participants reporting any solicited AEs. | During the 4 days after vaccination (Day 0 plus 3 days) |
| Frequency of Any Unsolicited AEs |
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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 |
None relevant
The study was non-randomized with a parallel assignment comprising of 2 groups of healthy volunteers: adults (aged 18 - 59 years) and older adults (aged 60 years or older).
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults (18 to 59 Years) | 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 (60 Years or Older) | 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 (18 to 59 Years) | 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 (60 Years or Older) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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) is 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) 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 included all participants who were vaccinated with the 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 (18 to 59 Years) | 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 |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 16 | 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 percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.
| After vaccination until the end of the study; approximately 21 days. |
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Adults (18 to 59 Years) |
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 (60 Years or Older) | 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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| Primary | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | GMFI (H1N1, H3N2, and B influenza virus strains) is 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 the 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 | Standard Deviation | fold increase | Approximately 21 days after vaccination |
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| 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 the 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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| Secondary | Frequency of Any Solicited Adverse Events (AEs) | The percentage of participants reporting any solicited AEs. | The Safety Population included all participants who received the 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 include AEs other than those specifically solicited. | The Safety Population included all participants who received the 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 |
| 40 |
| 60 |
| EG001 | Older Adults (60 Years or Older) | 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 | 16 | 60 |
| Malaise | General disorders | MedDRA 16 | Systematic Assessment |
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| Chills | General disorders | MedDRA 16 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16 | Non-systematic Assessment | unsolicited adverse event |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | Non-systematic Assessment | unsolicited adverse event |
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| Pyrexia | General disorders | MedDRA 16 | Non-systematic Assessment | unsolicited adverse event |
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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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| Chills |
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| Malaise |
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