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

Influenza Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113580
• Other study ID #: CSLCT-ASU-10-66
• Secondary ID: 2010-019532-12
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: October 18, 2017
• Start date: May 2010
• Est. completion date: May 2010

Study information

• Verified date: October 2017
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Chiltern (Early Phase) Limited	Dundee	Angus and Dundee

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The Percentage of Evaluable Participants Achieving a HI Titre = 40 or Single Radial Haemolysis (SRH) Area = 25 mm2.		Approximately 21 days after vaccination
Secondary	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)
Secondary	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