A Phase II, Double Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (= 18 to = 45 years) and Older Adults (= 60 years).

CSL Limited0 sites720 target enrollmentMarch 9, 2007

ConditionsProphylaxis of Influenza

DrugsEnzira

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prophylaxis of Influenza
Sponsor: CSL Limited
Enrollment: 720
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 9, 2007

End Date

September 30, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

CSL Limited

Eligibility Criteria

Inclusion Criteria

•All Cohorts:
•1\.Provision of written informed consent to participate in the study and willingness to adhere to all protocol requirements prior to any study procedures;
•2\.Ability to provide a pre\-vaccination venous blood sample of up to 66 mL without undue distress/discomfort. Participants must not have donated blood within the 3 months prior to Screening.
•Healthy Adult Cohort: Cohort A Additional Inclusion Criteria:
•1\.Healthy males or females, aged \= 18 to \= 45 years at the time of providing informed consent;
•2\.Negative urine pregnancy test at enrolment before receiving Study Vaccine (Female participants of childbearing potential ONLY – defined as not surgically sterilised or less than one year post\-menopausal). Those at risk of pregnancy or males at risk of causing pregnancy during the active study period must, in the opinion of the PI/delegate, be taking/using adequate methods of contraception. Adequate methods are defined as:
•·Oral contraception
•·Intrauterine contraceptive device
•·Depot contraceptive (implants/injectables)
•·Abstinence

Exclusion Criteria

•1\.Have a known allergy to eggs, chicken protein, neomycin, polymyxin, any other component in the study vaccines, or previous influenza vaccinations.
•2\.Have a history of, are suspected of having, or have active and clinically significant hepatic, immunodeficiency (including congenital or acquired), haematological, or autoimmune disorders; or have active infections, especially chronic infections (including tuberculosis, HIV infection or chronic hepatitis B or C infection).
•3\.Have a history of, are suspected of having, or have had cancer with metastatic disease, or have a primary cancer that has been untreated or not adequately treated. Specifically, participants must not have been treated with cytotoxic drugs or radiotherapy at any time during the six months prior to study entry. Participants with a history of breast or prostate cancer who are undergoing hormonal therapy (such as with tamoxifen or diethylstilbesterol) following adequate treatment of the primary disease may be enrolled. Participants with locally treated skin cancers without metastatic spread may also be enrolled.
•4\.Have active and clinically significant gastrointestinal, renal, neurological, cardiovascular, respiratory, or endocrine disorders; if
•·The Investigator feels the condition may adversely affect the participant through study participation; or
•·The Investigator feels that the condition is not currently well controlled/stable.
•5\.Have any abnormal liver function test (LFT) measure including:
•·ALT or AST; increase in factor of \> 2\.5 x ULN
•·Bilirubin – when accompanied by any increase in LFT; increase by factor of \> 1\.25 x ULN
•·Bilirubin – when LFT is normal; increase by factor of \> 1\.5 x ULN