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).
- Conditions
- Prophylaxis of Influenza
- Registration Number
- EUCTR2007-000272-16-GB
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 720
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 < 75 yrs: Cohort B Additional Inclusion Criteria:
1.Community dwelling males or females, aged = 60 and <75 years at the time of providing informed consent.
Older Adult Cohort = 75 yrs: Cohort C Additional Inclusion Criteria:
1.Community dwelling males or females, aged = 75 years at the time of providing informed consent.
Older Adult Long-term Care Facility Cohort: Cohort D Additional Inclusion Criteria:
1.Males or females, aged = 60 years at the time of providing informed consent, resident in long-term care facility (providing some degree of assisted care).
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
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 <=140x10-9/L
9.Have participated in a clinical trial where they received an investigational product, or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 30 days prior to receiving the Study Vaccines, or plans to enter a clinical trial during the study period;
10.Have been vaccinated with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to study entry;
11.Be undergoing current (or within the 90 days prior to receiving the Study Vaccines) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
·Chronic or long term corticosteroids: >= 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method