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

Phase 4

Completed

• Conditions: Influenza, Human
• Interventions: Biological: CSL Influenza Vaccine

• Registration Number: NCT01591837
• Lead Sponsor: Seqirus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-06-06
• Results First Submitted QC: 2013-10-25
• Results First Posted: 2013-11-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adults	CSL Influenza Vaccine	Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
Older Adults	CSL Influenza Vaccine	Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.

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) 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.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.	Approximately 21 days 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.
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
Frequency and Intensity 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 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.
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