Influenza, Human
Conditions
Brief summary
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.
Interventions
BIOLOGICALTrivalent Influenza Vaccine
Sponsors
Seqirus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females aged between 18 and 60 years at the time of vaccination. * Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.
Exclusion criteria
* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine. * Clinical signs of an active infection. * A clinically significant medical condition. * 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 (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 Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | Approximately 21 days 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 Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | Approximately 21 days after vaccination | For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type and Frequency of Any Solicited Adverse Events (AEs) | During the 4 days after vaccination (Day 0 plus 3 days) | The percentage of participants reporting any solicited AEs. |
| Type and Frequency of Any Unsolicited AEs | After vaccination until the end of the study; approximately 21 days. | The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited. |
Countries
United Kingdom
Participant flow
Recruitment details
The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Trivalent Influenza Vaccine |
|---|---|
| Age, Customized | 31.8 years STANDARD_DEVIATION 10.12 |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 81 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
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.
Time frame: Approximately 21 days after vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Trivalent Influenza Vaccine | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | H1N1 strain | 15.01 fold increase | Standard Deviation 4.27 |
| Trivalent Influenza Vaccine | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | H3N2 strain | 13.18 fold increase | Standard Deviation 4.494 |
| Trivalent Influenza Vaccine | The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | B strain | 5.86 fold increase | Standard Deviation 3.461 |
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.
Time frame: Approximately 21 days after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | H1N1 strain | 97.5 percentage of participants |
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | H3N2 strain | 99.2 percentage of participants |
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. | B strain | 95.0 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 (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.
Time frame: Approximately 21 days after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | H1N1 strain | 79 percentage of participants |
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | H3N2 strain | 79 percentage of participants |
| Trivalent Influenza Vaccine | The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | B strain | 64.7 percentage of participants |
Secondary
Type and Frequency of Any Solicited Adverse Events (AEs)
The percentage of participants reporting any solicited AEs.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
Population: The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Any solicited local AE | 52.5 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Induration > 50 mm | 0.8 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Erythema | 10 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Ecchymosis | 8.3 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Pain | 51.7 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Any solicited systemic AE | 19.2 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Temperature > 38°C for ≥ 24 hours | 0 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Chills | 10.8 percentage of participants |
| Trivalent Influenza Vaccine | Type and Frequency of Any Solicited Adverse Events (AEs) | Malaise | 17.5 percentage of participants |
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.
Time frame: After vaccination until the end of the study; approximately 21 days.
Population: The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Vaccine | Type and Frequency of Any Unsolicited AEs | 44.2 percentage of participants |