A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

Seqirus120 enrolled

Overview

The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Influenza

Interventions

CSL's 2010/2011 Formulation of Enzira® VaccineBIOLOGICAL

45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18 years and older at the time of the first study vaccination. Exclusion Criteria: * Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine. * Clinical signs of an active infection * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry * Females who are pregnant or lactating

Locations (1)

Chiltern (Early Phase) Limited

Dundee, Angus and Dundee, 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 is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase is 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 is 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.

Time frame: Approximately 21 days after vaccination

Secondary Outcomes

Frequency of Any Solicited Adverse Events (AEs)

The number of participants reporting any solicited AEs.

Time frame: During the 4 days after vaccination (Day 0 plus 3 days)

Frequency and Intensity of Any Unsolicited Adverse Events

Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities.

Time frame: After vaccination until the end of the study; approximately 21 days

Data from ClinicalTrials.gov

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