Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001420-19 | EudraCT Number |
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
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trivalent Influenza Vaccine | Experimental | The study 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent Influenza Vaccine | Biological |
|
| 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 |
|---|---|---|
| Type and 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) |
| Type and Frequency of Any Unsolicited AEs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| bioCSL Head of Clinical Operations | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | London | NW10 7EW | United Kingdom |
Not provided
The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trivalent Influenza Vaccine | Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trivalent Influenza Vaccine | Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent 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, Customized | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | 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 includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre 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 |
|
|
| |||||||||||||||||||||||||||||||||||
| 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 includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre 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 |
|
| ||||||||||||||||||||||||||||||||||||
| 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 includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre 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 | Type and Frequency of Any Solicited Adverse Events (AEs) | The percentage of participants reporting any solicited AEs. | The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | During the 4 days after vaccination (Day 0 plus 3 days) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Type and 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 Trivalent Influenza Vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | After vaccination until the end of the study; approximately 21 days. |
|
|
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 Trivalent Influenza Vaccine and provided follow-up safety data.
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 | Trivalent Influenza Vaccine | Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection. | 0 | 120 | 81 | 120 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | Gastrointestinal disorders | MedDRA 16 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 16 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 16 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16 | Non-systematic Assessment | Unsolicited adverse event |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Seqirus | 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
|
|
|
|