Prophylaxis of Influenza
Conditions
Interventions
Product Name: CSL412 Formulation 1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/New Caledonia/20/99
A/Hiroshima/52/2005
B/Malaysia/2506/2004
Other descriptive name: influenza haemagglutinin antigens
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
CSL Limited
Eligibility
Sex/Gender
All
Inclusion 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 · Partner Vasectomy · Condoms with spermicide Older Adult Cohort = 60 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 Note: Participants with Gilbert’s syndrome may be eligible for enrolment 6.Have abnormal renal function as defined by a creatinine level > 0.13 mmol/L. 7.Have been vaccinated against influenza in 2007. 8.Have an abnormally low platelet count, with a platelet count = 15 mg/day of oral prednisolone or equivalent daily; · Sporadic corticosteroids: >= 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the three months preceding vaccination; · Administration of immunogobulins and/or any blood products within the 3 months preceding study entry or during the study Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccines or throughout the Study is acceptable. 12.Be undergoing cur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of CSL412 in Older Adults (aged = 60 years) against the immunogenicity criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. To evaluate the safety and tolerability of CSL412 as compared to active comparator vaccine. ; Secondary Objective: To assess the safety and tolerability of CSL412 in terms of solicited local and general adverse events, unsolicited adverse events and serious adverse events Exploratory Objectives: To compare the T cell response in Older Adults vaccinated with CSL412 to the T cell response in Adults and Older Adults vaccinated with unadjuvanted trivalent inactivated influenza vaccine. To compare the T cell response in Older Adults vaccinated with CSL412 to the T cell response in Adults vaccinated with CSL412 ; Primary end point(s): The immune response to influenza haemagglutinin antigens (measured by serum HI antibody assay) following vaccination with CSL412, evaluated as: 1. Seroprotection rate: the proportion of participants achieving post vaccination HI titres >= 40. 2. The geometric mean of the fold increase in HI titre post-vaccination. 3. Seroconversion or significant increase rate: the proportion of participants achieving seroconversion (pre-vaccination HI titre = 40) or significant increase in HI titre (pre vaccination HI titre >= 10 and >=4-fold increase in HI titre post-vaccination). 4.Each strain should meet at least one of the three CPMP immunogenicity requirements for Older Adults (>= 60 years), namely: Seroprotection rate > 60%, GM Fold increase > 2.0, or seroconversion/significant increase rate > 30%. 5.Rate of occurrence of study vaccine-associated Grade 3 or higher fever,or study vaccine-associated vaccination site ulceration,abscess or necrosis | — |
Countries
United Kingdom
Outcome results
None listed