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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

• Registration Number: NCT01113580
• Lead Sponsor: Seqirus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-30
• Study Start: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-06-13
• Results First Submitted QC: 2012-06-13
• Results First Posted: 2012-07-18
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adults	CSL's 2010/2011 Formulation of Enzira® Vaccine	Healthy volunteers aged 18 to 59 years
Older Adults	CSL's 2010/2011 Formulation of Enzira® Vaccine	Healthy volunteers aged 60 years or older

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 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.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.	Approximately 21 days after vaccination
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.	Approximately 21 days after vaccination	GMFI 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 number of participants reporting any solicited AEs.
Frequency and Intensity of Any Unsolicited Adverse Events	After vaccination until the end of the study; approximately 21 days	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.

Trial Locations

Locations (1)

Chiltern (Early Phase) Limited; 🇬🇧 Dundee, Angus and Dundee, United Kingdom