Clinical trial NCT00888381: A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 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 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
timeFrame: Approximately 21 days after vaccination
measure: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
timeFrame: Approximately 21 days after vaccination
measure: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
timeFrame: Approximately 21 days after vaccination
Secondary outcomes:
measure: The Frequency of Any Solicited Local Reactions.
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: The Frequency of Any Solicited Systemic Symptoms.
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: The Incidence of Any Unsolicited Adverse Events (AEs).
timeFrame: After vaccination until the end of the study; approximately 21 days
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References: