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

Seqirus120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Influenza, Human

Interventions

CSL Influenza VaccineBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Study Site

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Approximately 21 days after vaccination

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.

Time frame: Approximately 21 days after vaccination

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.

Time frame: Approximately 21 days after vaccination

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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