A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers

A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: CSL Influenza Vaccine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults; Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.	Biological: CSL Influenza Vaccine; The study vaccine (CSL Influenza 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 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.; Other Names: Afluria® vaccine; Enzira® vaccine
Experimental: Older Adults; Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.	Biological: CSL Influenza Vaccine; The study vaccine (CSL Influenza 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 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.; Other Names: Afluria® vaccine; Enzira® vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 21 days after vaccination
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) was 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) was defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.	Approximately 21 days after vaccination
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.	GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.	Approximately 21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Intensity of Any Solicited Adverse Events (AEs).	The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only. Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site. Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise. Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities.	During the 4 days after vaccination (Day 0 plus 3 days)
Frequency of Any Unsolicited AEs.	The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.	After vaccination until the end of the study; approximately 21 days

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Director Vaccines, Seqirus

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 3, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CSLCT-ASU-12-76; 2012-001101-24 (EudraCT Number)