MedDataX Logo

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

NCT ID: NCT01113580

Last Updated: 2017-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults

Healthy volunteers aged 18 to 59 years

Group Type EXPERIMENTAL

CSL's 2010/2011 Formulation of Enzira® Vaccine

Intervention Type BIOLOGICAL

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

Older Adults

Healthy volunteers aged 60 years or older

Group Type EXPERIMENTAL

CSL's 2010/2011 Formulation of Enzira® Vaccine

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CSL's 2010/2011 Formulation of Enzira® Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronnie Beboso, Dr

Role: PRINCIPAL_INVESTIGATOR

Chiltern (Early Phase) Limited

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chiltern (Early Phase) Limited

Dundee, Angus and Dundee, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-019532-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSLCT-ASU-10-66

Identifier Type: -

Identifier Source: org_study_id