A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers - Full Text View

Purpose

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Condition	Intervention	Phase
Influenza	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]
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.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]
GMFI 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. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Frequency of Any Solicited Local Reactions. [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ] [ Designated as safety issue: Yes ]
The number of participants reporting any solicited local reactions.
The Frequency of Any Solicited Systemic Symptoms. [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ] [ Designated as safety issue: Yes ]
The number of participants reporting any solicited systemic symptoms.
The Incidence of Any Unsolicited Adverse Events (AEs). [ Time Frame: After vaccination until the end of the study; approximately 21 days ] [ Designated as safety issue: Yes ]
The number of participants reporting any unsolicited adverse events.

Unsolicited adverse event (UAE) grading:

Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities.

Enrollment:	120
Study Start Date:	May 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adults Healthy volunteers aged 18 to 59 years	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation) A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0. Other Name: Enzira® vaccine (2009 / 2010 formulation)
Experimental: Older Adults Healthy volunteers aged 60 years or older	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation) A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0. Other Name: Enzira® vaccine (2009 / 2010 formulation)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males or females aged ≥ 18 years at the time of providing informed consent
Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
Willing and able to adhere to all protocol requirements
Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
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

Exclusion Criteria:

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
A clinically significant medical or psychiatric condition
A confirmed or suspected immunosuppressive condition
History of seizures
History of Guillain-Barré Syndrome
Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
Currently receiving treatment with warfarin or other anticoagulants
Evidence or history of substance or alcohol abuse within the 12 months before study entry
Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
Females who are pregnant or lactating
Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888381

Locations

United Kingdom
Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Dr Ronnie Beboso

Chiltern (Early Phase) Limited

More Information

No publications provided

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00888381 History of Changes
Other Study ID Numbers:	CSLCT-NHF-09-57, 2009-011450-18
Study First Received:	April 24, 2009
Results First Received:	June 13, 2012
Last Updated:	June 13, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013