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

Influenza Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888381
• Other study ID #: CSLCT-NHF-09-57
• Secondary ID: 2009-011450-18
• Status: Completed
• Phase: Phase 4
• Start date: May 2009
• Est. completion date: May 2009

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Inactivated Influenza Vaccine (2009 / 2010 formulation)
A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.

Locations

Country	Name	City	State
United Kingdom	Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 21 days after vaccination
Primary	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.	Approximately 21 days after vaccination
Primary	The Percentage of Evaluable Participants Achieving a HI Titre = 40 or Single Radial Haemolysis (SRH) Area = 25 mm2.		Approximately 21 days after vaccination
Secondary	The Frequency of Any Solicited Local Reactions.	The number of participants reporting any solicited local reactions.	During the 4 days after vaccination (Day 0 plus 3 days)
Secondary	The Frequency of Any Solicited Systemic Symptoms.	The number of participants reporting any solicited systemic symptoms.	During the 4 days after vaccination (Day 0 plus 3 days)
Secondary	The Incidence of Any Unsolicited Adverse Events (AEs).	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.	After vaccination until the end of the study; approximately 21 days