Phase 3
Completed N=3,484
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Influenza, Human
Source: ClinicalTrials.gov NCT02214225 ↗
Enrolled (actual)
3,484
Serious AEs
1.9%
Results posted
Feb 2016
Primary outcomePrimary: Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). — 303.0; 280.2; 488.7; 454.2 Titer
Summary
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). |
303.0; 280.2; 488.7; 454.2; 64.3; 55.7 | — |
| PRIMARY The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. |
38.8; 37.7; 40.9; 39.3; 31.0; 27.8 | — |
| SECONDARY Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population). |
432.7; 402.8; 211.4; 199.8; 569.1; 515.1 | — |
| SECONDARY The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population). |
51.3; 49.1; 26.6; 26.4; 56.3; 51.7 | — |
| SECONDARY Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population). |
62.9; 42.7; 86.9; 55.4; 89.9; 53.8 | — |
| SECONDARY Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population) |
31.0; 15.6; 40.3; 20.3; 45.7; 22.8 | — |
| SECONDARY Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination. |
78.1; 82.3; 82.8; 75.7; 72.0; 69.2 | — |
| SECONDARY Geometric Mean Fold Titer Change From Prevaccination to Postvaccination. |
5.5; 5.3; 5.2; 2.3; 2.4; 2.3 | — |
| SECONDARY Seroprotection Rates Prevaccination and Postvaccination. |
73.2; 76.9; 75.5; 78.5; 80.0; 77.4 | — |
| SECONDARY Seroconversion Rates |
51.3; 50.5; 47.7; 26.6; 27.4; 25.4 | — |
| SECONDARY The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs). |
803; 391; 397; 42; 15; 24 | — |
| SECONDARY The Frequency of Cellulitis-like Reaction and Cellulitis. |
0; 0; 0 | — |
| SECONDARY The Frequency and Severity of Unsolicited AEs. |
351; 191; 176; 73; 29; 33 | — |
| SECONDARY The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination. |
39; 14; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant females aged ≥ 18 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 On-study period. 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 dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
- Vaccination against influenza in the previous 6 months.
- Known history of Guillain-Barré Syndrome or other demyelinating disease.
- Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
- A clinically significant medical condition.
- Pregnant or lactating females.
Data sourced from ClinicalTrials.gov (NCT02214225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.