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

Influenza, Human Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591837
• Other study ID #: CSLCT-ASU-12-76
• Secondary ID: 2012-001101-24
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Study Site	London

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 (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
Primary	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
Primary	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
Secondary	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)
Secondary	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