Influenza Vaccine study
- Registration Number
- CTRI/2012/10/003056
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
• During the first phase of recruitment (for DSMB review), no female subjects will be recruited.
• Informed consent must be obtained from the subject 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(s) 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. The use of inhaled and nasal steroids will be permitted.
• 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 0F.
• Any cardiopulmonary disease, including asthma, requiring ongoing medical therapy; known or suspected abnormal hepatic or renal function, or 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.
• Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
• Females who are found positive in Urinary Pregnancy Test; Pregnant or lactating female, and; Females planning to become pregnant or planning to discontinue contraceptive precautions within 60 days of enrollment in this study.
• Volunteers found positive in alcohol breath test and drugs of abuse test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of a single injection of Trivalent Seasonal Influenza VLP Vaccine <br/ ><br>To assess the immunogenicity of trivalent seasonal VLP Vaccine.Timepoint: Safety & tolerability for 180 days. <br/ ><br>Immunogenicity for 22±3 days.
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI