A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
- Conditions
- Influenza, Human
- Interventions
- Biological: Enzira® vaccine
- Registration Number
- NCT01857297
- Lead Sponsor
- Seqirus
- Brief Summary
This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Males or females aged 18 years or older 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Older Adults (aged 60 years or older) Enzira® vaccine The study vaccine (Enzira® 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. Adults (aged 18 to 59 years) Enzira® vaccine The study vaccine (Enzira® 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.
- Primary Outcome Measures
Name Time Method 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 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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 include AEs other than those specifically solicited.
Trial Locations
- Locations (1)
Study Site
🇬🇧London, United Kingdom