A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2010/2011 Formulation of Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

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

Contacts and Locations

Study Locations

• United Kingdom
  • Angus and Dundee
    • Dundee, Angus and Dundee, United Kingdom, DD1 9SY
      • Chiltern (Early Phase) Limited

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:

• Male or female aged 18 years and older at the time of the first study vaccination.

Exclusion Criteria:

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
• Clinical signs of an active infection
• 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	Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine; 45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0
Experimental: Older Adults; Healthy volunteers aged 60 years or older	Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine; 45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is 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 is 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
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.		Approximately 21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Any Solicited Adverse Events (AEs)	The number of participants reporting any solicited AEs.	During the 4 days after vaccination (Day 0 plus 3 days)
Frequency and Intensity of Any Unsolicited Adverse Events	Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities.	After vaccination until the end of the study; approximately 21 days

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Principal Investigator: Ronnie Beboso, Dr, Chiltern (Early Phase) Limited

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CSLCT-ASU-10-66; 2010-019532-12 (EudraCT Number)