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

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Trivalent Influenza Vaccine

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trivalent Influenza Vaccine

Arm Description

The study 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 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Type and Frequency of Any Solicited Adverse Events (AEs)

The percentage of participants reporting any solicited AEs.

Type and Frequency of Any Unsolicited AEs

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

Full Information

NCT ID

NCT01863433

First Posted

May 23, 2013

Last Updated

April 25, 2018

Sponsor

Seqirus

1. Study Identification

Unique Protocol Identification Number

NCT01863433

Brief Title

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

Official Title

A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seqirus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trivalent Influenza Vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine

Primary Outcome Measure Information:

Title

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.

Description

Time Frame

Approximately 21 days after vaccination

Title

The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.

Description

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

Title

The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.

Description

For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.

Time Frame

Approximately 21 days after vaccination

Secondary Outcome Measure Information:

Title

Type and Frequency of Any Solicited Adverse Events (AEs)

Description

The percentage of participants reporting any solicited AEs.

Time Frame

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

Title

Type and Frequency of Any Unsolicited AEs

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

bioCSL Head of Clinical Operations

Organizational Affiliation

Seqirus

Official's Role

Study Director

Facility Information:

Facility Name

Study Site

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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