A Phase 4 interventional study of CSL Influenza Vaccine in Influenza, Human, sponsored by Seqirus. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Seqirus · Phase 4, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 120 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Seqirus is the lead sponsor of 52 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
Biological: CSL Influenza Vaccine
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
Biological: CSL Influenza Vaccine
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.
Also known as: Enzira® vaccine, Afluria® vaccine
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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 21 days after vaccination
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.
Time frame: 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.
Time frame: After vaccination until the end of the study; approximately 21 days
| Milestone | Adults | Older Adults |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
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.
| percentage of participants | Adults | Older Adults |
|---|---|---|
| H1N1 strain | 79.7 (67.2 to 89.0) | 55.9 (42.4 to 68.8) |
| H3N2 strain | 86.4 (75.0 to 94.0) | 64.4 (50.9 to 76.4) |
| B strain | 59.3 (45.7 to 71.9) | 18.6 (9.7 to 30.9) |
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.
| geometric mean fold increase | Adults | Older Adults |
|---|---|---|
| H1N1 strain | 17.51 (11.857 to 25.852) | 7.78 (5.217 to 11.614) |
| H3N2 strain | 21.80 (14.332 to 33.164) | 9.88 (6.316 to 15.468) |
| B strain | 7.34 (5.592 to 9.634) | 2.44 (1.913 to 3.118) |
For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.
| percentage of participants | Adults | Older Adults |
|---|---|---|
| H1N1 strain | 94.9 (85.9 to 98.9) | 84.7 (73.0 to 92.8) |
| H3N2 strain | 100.0 (93.9 to 100.0) | 100.0 (93.9 to 100.0) |
| B strain | 66.1 (52.6 to 77.9) | 18.6 (9.7 to 30.9) |
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.
| percentage of participants | Adults | Older Adults |
|---|---|---|
| Any solicited local AE | 46.7 | 18.3 |
| Induration > 50 mm | 0.0 | 3.3 |
| Erythema | 15.0 | 6.7 |
| Ecchymosis | 6.7 | 3.3 |
| Pain | 41.7 | 10.0 |
| Any solicited systemic AE | 15.0 | 6.7 |
| Temperature > 38°C for ≥ 24 hours | 0 | 1.7 |
| Severe temperature (> 40°C) | 0 | 1.7 |
| Chills | 10.0 | 3.3 |
| Malaise | 13.3 | 6.7 |
The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.
| percentage of participants | Adults | Older Adults |
|---|---|---|
| Frequency of Any Unsolicited AEs. | 53.3 | 36.7 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adults | — | 0/60 (0%) | 36/60 (60%) |
| Older Adults | — | 0/60 (0%) | 18/60 (30%) |
| Event | Adults | Older Adults |
|---|---|---|
| PainGeneral disorders | 25/60 | 6/60 |
| HeadacheNervous system disorders | 15/60 | 5/60 |
| ErythemaGeneral disorders | 9/60 | 4/60 |
| MalaiseGeneral disorders | 8/60 | 4/60 |
| ChillsGeneral disorders | 6/60 | 2/60 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/60 | 5/60 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 5/60 | 4/60 |
| EcchymosisGeneral disorders | 4/60 | 2/60 |
| Age, Continuous(years) | Adults | Older Adults | Total |
|---|---|---|---|
| Mean | 35.2 ± 12.50 | 69.2 ± 6.69 | 52.2 ± 19.78 |
| Sex: Female, Male(Participants) | Adults | Older Adults | Total |
|---|---|---|---|
| Female | 38 | 29 | 67 |
| Male | 22 | 31 | 53 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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