A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

Phase 4

Completed

• Conditions: Influenza, Human

• Registration Number: NCT01863433
• Lead Sponsor: Seqirus

Brief Summary

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2013-11-26
• Results First Submitted QC: 2013-11-26
• Results First Posted: 2014-01-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

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

Inclusion Criteria

• Males or females aged between 18 and 60 years 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 (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.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.	Approximately 21 days 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.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.	Approximately 21 days after vaccination	For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.

Secondary Outcome Measures

Name	Time	Method
Type and Frequency of Any Solicited Adverse Events (AEs)	During the 4 days after vaccination (Day 0 plus 3 days)	The percentage of participants reporting any solicited AEs.
Type and Frequency of Any Unsolicited AEs	After vaccination until the end of the study; approximately 21 days.	The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.

Trial Locations

Locations (1)

Study Site; 🇬🇧 London, United Kingdom