Phase 4
Completed N=120
A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Influenza, Human
Source: ClinicalTrials.gov NCT01863433 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. — 79; 79; 64.7 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. |
79; 79; 64.7 | — |
| PRIMARY The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. |
15.01; 13.18; 5.86 | — |
| PRIMARY The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. |
97.5; 99.2; 95.0 | — |
| SECONDARY Type and Frequency of Any Solicited Adverse Events (AEs) |
52.5; 0.8; 10; 8.3; 51.7; 19.2 | — |
| SECONDARY Type and Frequency of Any Unsolicited AEs |
44.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01863433). 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.