A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 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 2013/2014 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: NCT01857297
• Other study ID #: CSLCT-ASU-12-82
• Secondary ID: 2013-000945-37
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: June 2013

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 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• 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:
• Enzira® vaccine

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) is 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) 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 (H1N1, H3N2, and B influenza virus strains) 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.	For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.	Approximately 21 days after vaccination
Secondary	Frequency of Any Solicited Adverse Events (AEs)	The percentage of participants reporting any solicited AEs.	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 include AEs other than those specifically solicited.	After vaccination until the end of the study; approximately 21 days.