Influenza
Conditions
Brief summary
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.
Interventions
BIOLOGICALCSL's 2010/2011 Formulation of Enzira® Vaccine
45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0
Sponsors
Seqirus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 18 years and older at the time of the first study vaccination.
Exclusion criteria
* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine. * Clinical signs of an active infection * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry * Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | Approximately 21 days after vaccination | 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 Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | Approximately 21 days 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 Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | Approximately 21 days after vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Any Solicited Adverse Events (AEs) | During the 4 days after vaccination (Day 0 plus 3 days) | The number of participants reporting any solicited AEs. |
| Frequency and Intensity of Any Unsolicited Adverse Events | After vaccination until the end of the study; approximately 21 days | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adults Healthy volunteers aged 18 to 59 years | 60 |
| Older Adults Healthy volunteers aged 60 years or older | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Adults | Older Adults | Total |
|---|---|---|---|
| Age, Customized 18 to 59 years | 60 participants | 0 participants | 60 participants |
| Age, Customized < 18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >= 60 years | 0 participants | 60 participants | 60 participants |
| Sex: Female, Male Female | 29 Participants | 24 Participants | 53 Participants |
| Sex: Female, Male Male | 31 Participants | 36 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 60 | 15 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: Approximately 21 days after vaccination
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | A/California/7/2009 (H1N1)-like strain | 20.48 Fold increase |
| Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | A/Perth/16/2009 (H3N2)-like strain | 24.70 Fold increase |
| Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | B/Brisbane/60/2008-like strain | 6.63 Fold increase |
| Older Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | A/California/7/2009 (H1N1)-like strain | 12.90 Fold increase |
| Older Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | A/Perth/16/2009 (H3N2)-like strain | 11.53 Fold increase |
| Older Adults | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | B/Brisbane/60/2008-like strain | 2.77 Fold increase |
Primary
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
Time frame: Approximately 21 days after vaccination
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | A/California/7/2009 (H1N1)-like strain | 91.4 Percentage of participants |
| Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | A/Perth/16/2009 (H3N2)-like strain | 98.3 Percentage of participants |
| Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | B/Brisbane/60/2008-like strain | 89.7 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | A/California/7/2009 (H1N1)-like strain | 90.0 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | A/Perth/16/2009 (H3N2)-like strain | 96.7 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | B/Brisbane/60/2008-like strain | 70.0 Percentage of participants |
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.
Time frame: Approximately 21 days after vaccination
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | A/California/7/2009 (H1N1)-like strain | 89.7 Percentage of participants |
| Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | A/Perth/16/2009 (H3N2)-like strain | 89.7 Percentage of participants |
| Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | B/Brisbane/60/2008-like strain | 63.8 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | A/California/7/2009 (H1N1)-like strain | 80.0 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | A/Perth/16/2009 (H3N2)-like strain | 71.7 Percentage of participants |
| Older Adults | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | B/Brisbane/60/2008-like strain | 28.3 Percentage of participants |
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.
Time frame: After vaccination until the end of the study; approximately 21 days
Population: The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants with at least one UAE | 28 participants |
| Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting mild UAE | 22 participants |
| Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting moderate UAE | 7 participants |
| Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting severe UAE | 3 participants |
| Older Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting severe UAE | 2 participants |
| Older Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants with at least one UAE | 22 participants |
| Older Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting moderate UAE | 2 participants |
| Older Adults | Frequency and Intensity of Any Unsolicited Adverse Events | Number of participants reporting mild UAE | 19 participants |
Secondary
Frequency of Any Solicited Adverse Events (AEs)
The number of participants reporting any solicited AEs.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
Population: The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any induration larger than 50 mm | 2 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any general (systemic) solicited AE | 4 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any ecchymosis | 5 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any temperature above 38 degrees C for ≥ 24 hours | 0 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any erythema | 22 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any chills | 4 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any pain | 22 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any malaise | 3 participants |
| Adults | Frequency of Any Solicited Adverse Events (AEs) | Any local solicited AE | 32 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any malaise | 2 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any local solicited AE | 18 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any induration larger than 50 mm | 0 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any erythema | 9 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any ecchymosis | 4 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any pain | 10 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any general (systemic) solicited AE | 3 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any temperature above 38 degrees C for ≥ 24 hours | 3 participants |
| Older Adults | Frequency of Any Solicited Adverse Events (AEs) | Any chills | 2 participants |