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).
Verified date | April 2018 |
Source | Seqirus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School | Dundee |
Lead Sponsor | Collaborator |
---|---|
Seqirus |
United Kingdom,
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 |
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