A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

Seqirus120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Influenza, Human

Interventions

Enzira® vaccineBIOLOGICAL

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) 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.

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) 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.

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 of Any Solicited Adverse Events (AEs)

The percentage of participants reporting any solicited AEs.

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

Frequency of Any Unsolicited AEs

The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.

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

Data from ClinicalTrials.gov

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