Clinical study to compare the immune response and safety of trivalent flu vaccine manufactured by Cadila Healthcare Ltd. with a trivalent flu vaccine marketed in India in healthy adults
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2015/09/006208
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 348
1. Healthy subject of either gender >= 18 years of age
2. Written informed consent from subjects
3. Adult subjects literature enough to fill the diary card
1. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??Barré syndrome or others) or any serious adverse event to any component of influenza vaccine, egg, chicken proteins, aminoglycoside antibiotics
2. Subjects with history of administration of any influenza vaccine within the past 6 months or subjects with laboratory confirmed influenza in past
3. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
5. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
6. Subjects with febrile illness (temperature >= 100.4oF) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
7. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
8. Any other vaccine administration within the last 30 days or planned to be administered during the study period
9. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
10. Participation in another clinical trial in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Serologic parameters set by the Committee for Medicinal Products for Human Use (CHMP) for influenza vaccines <br/ ><br>2. Seroconversion rate for all the three viral strains in the two groups at the end of studyTimepoint: 21 days following vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean titres for all the three viral strains in the two groups at the end of the studyTimepoint: 21 days following vaccination;Local and systemic adverse events reported during the studyTimepoint: 42 days following vaccination;Seroprotection rate for all the three viral strains in the two groups at the end of the studyTimepoint: 21 days following vaccination