A Phase 4 interventional study of Trivalent Influenza Vaccine in Influenza, Human, sponsored by Seqirus. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by Seqirus · Phase 4, Interventional, and Prevention
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.
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:
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.
Biological: Trivalent Influenza 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) 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
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
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
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)
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.
The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.
| Milestone | Trivalent Influenza Vaccine |
|---|---|
| Started | 120 |
| Completed | 119 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
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.
| percentage of participants | Trivalent Influenza Vaccine |
|---|---|
| H1N1 strain | 79 (70.6 to 85.9) |
| H3N2 strain | 79 (70.6 to 85.9) |
| B strain | 64.7 (55.4 to 73.2) |
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.
| fold increase | Trivalent Influenza Vaccine |
|---|---|
| H1N1 strain | 15.01 ± 4.27 |
| H3N2 strain | 13.18 ± 4.494 |
| B strain | 5.86 ± 3.461 |
For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.
| percentage of participants | Trivalent Influenza Vaccine |
|---|---|
| H1N1 strain | 97.5 (92.8 to 99.5) |
| H3N2 strain | 99.2 (95.4 to 100.0) |
| B strain | 95.0 (89.3 to 98.1) |
The percentage of participants reporting any solicited AEs.
| percentage of participants | Trivalent Influenza Vaccine |
|---|---|
| Any solicited local AE | 52.5 |
| Induration > 50 mm | 0.8 |
| Erythema | 10 |
| Ecchymosis | 8.3 |
| Pain | 51.7 |
| Any solicited systemic AE | 19.2 |
| Temperature > 38°C for ≥ 24 hours | 0 |
| Chills | 10.8 |
| Malaise | 17.5 |
The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.
| percentage of participants | Trivalent Influenza Vaccine |
|---|---|
| Type and Frequency of Any Unsolicited AEs | 44.2 |
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 |
|---|---|---|---|
| Trivalent Influenza Vaccine | — | 0/120 (0%) | 81/120 (67.5%) |
| Event | Trivalent Influenza Vaccine |
|---|---|
| Injection site painGeneral disorders | 62/120 |
| HeadacheNervous system disorders | 32/120 |
| MalaiseGeneral disorders | 21/120 |
| ChillsGastrointestinal disorders | 13/120 |
| Injection site erythemaGeneral disorders | 12/120 |
| Injection site haemorrhageGeneral disorders | 10/120 |
| Age, Customized(years) | Trivalent Influenza Vaccine |
|---|---|
| Mean | 31.8 ± 10.12 |
| Sex: Female, Male(Participants) | Trivalent Influenza Vaccine |
|---|---|
| Female | 63 |
| Male | 57 |
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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