A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
- Conditions
- Influenza, Human
- Interventions
- Biological: Trivalent Influenza Vaccine
- Registration Number
- NCT01863433
- Lead Sponsor
- Seqirus
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trivalent Influenza Vaccine Trivalent Influenza Vaccine 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.
- 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 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.
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.
- Secondary Outcome Measures
Name Time Method Type and 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.
Type and 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 included AEs other than those specifically solicited.
Trial Locations
- Locations (1)
Study Site
🇬🇧London, United Kingdom