A study to test the safety of a new trivalent seasonal influenza vaccine in healthy volunteers
- Registration Number
- CTRI/2014/10/005107
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
•Healthy volunteers of either sex between 18-64 years of age, inclusive
•Informed consent must be obtained from the volunteer prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period
•Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection
•History of hypersensitivity to any component of inactivated influenza vaccines
•Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the administration of the study vaccine (inhaled & topical steroids are allowed)
•Use of systemic glucocorticoids within one month prior to randomization
•Any clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests
•Screening serum transaminase or alkaline phosphatase more than 3 times of ULN, creatinine and total bilirubin 1.5 times of ULN, Hgb 10 gm/dl, or BMI 28
•Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
•Administration of immunoglobulin and/or any blood products within the three months preceding the administration of the study vaccine or during the study
•Acute illness of moderate or severe intensity at the time of enrollment, including any illness associated with fever >=100.5 F
•Any congenital abnormalities, including hemglobinopathies, which could increase the risk of influenza complications
•History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome.
•Women who are found to have a positive urinary pregnancy test; pregnant or lactating history or physical examination, or planning to become pregnant or to discontinue contraceptive precautions within 60 days of enrollment in this study
•Volunteers found positive in drugs of abuse test
•History of Congenital or acquired immunodeficiency, or of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
•Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method immunogenicity of Trivalent Seasonal influenza VLP vaccineTimepoint: Seroconversion rate (Time frame: 22 days post-vaccination) <br/ ><br> <br/ ><br>Seroprotection rate (Time frame: 22 days post-vaccination) <br/ ><br> <br/ ><br>Geometric Mean fold-rise (Time frame: 22 days post-vaccination)
- Secondary Outcome Measures
Name Time Method safety and tolerability of Trivalent seasonal influenza VLP vaccineTimepoint: Solicited adverse events (Time frame: 7 days post-vaccination) <br/ ><br> <br/ ><br>Unsolicited adverse events (Time frame: 22 days post-vaccination)