A Randomized, Observer-Blind, Single-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Enzira 2005/2006 compared to Mutagrip 2005/2006 in Healthy 'Adults@ aged >18 to <60 years and in Healthy 'Older Adults' aged >60 years

Phase 1

• Conditions: prophylaxis of influenza

• Registration Number: EUCTR2005-003331-44-GB
• Lead Sponsor: CSL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-02
• Study Completion: 2005-11-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1.Healthy males or females, aged > 18 years at the time of providing informed consent
2.Provision of written informed consent to participate in the study and willingness to adhere to all protocol requirements
3.Ability to provide a sample of up to 20 mL of venous blood without undue distress/discomfort on two occasions
4.Negative pregnancy test at enrolment before receiving Study Vaccine (Female participants of childbearing potential ONLY). Those at risk of pregnancy during the study period must, in the opinion of the Investigator/delegate, be taking/using adequate methods of contraception Adequate methods are defined as:
·Oral contraception
·Intrauterine contraceptive device
·Depot contraceptive (implants/injectables)
·Abstinence
·Partner Vasectomy
·Condoms with spermicide
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Hypersensitivity to the active substances, to any of the excipients or to residues of the production process in either Study Vaccine (eggs, egg protein, chicken protein, neomycin, polymyxin, formaldehyde, diethylether or polysorbate 80)
2.Vaccination against influenza within the previous 6 months
3.Clinical signs of active infection and/or an oral temperature of ³ 38°C at study entry. Study entry may be deferred for such individuals, at the discretion of the PI/delegate.
4.Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder
5.Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:·Chronic or long term corticosteroids: >15mg/day of oral prednisolone or equivalent daily;·Sporadic corticosteroids: >40mg/day of oral prednisolone or equivalent for more than two courses of >14 days in the three months preceding vaccination;Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable.
6.Participation in a clinical trial or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or plans to enter another study during the study period
7.Vaccination with any registered vaccine within 30 days prior to receiving the Study Vaccine
8.Current treatment, or treatment with cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine
9.Known history of Guillan-Barré Syndrome
10.Active neurological disease
11.Current treatment with warfarin or other anticoagulant
12.Physical/Medical history that the Investigator feels may affect the participant or study results
13.Evidence, or history (within the previous 12 months) of drug or alcohol abuse
14.Unwillingness or inability to comply with the study protocol
15.History of psychiatric disorders, which, in the opinion of the Principal Investigator, would prevent participants from giving proper informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified