A clinical trial to study the immunogenicity and safety of Inactivated Influenza Vaccine in healthy adult volunteers
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2010/091/000182
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Healthy adult volunteers of either gender more than 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
2.If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the study period.
3.Subjects likely to be available for all visits during the follow-up period.
4.Willing to sign Informed consent.
1.Pregnancy & Lactation.
2.Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, egg proteins, neomycin or polymixin, or products containing mercury.
3.Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
4.Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive.
5.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
6.Subjects who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days or individuals who have had suspected/confirmed pandemic influenza H1N1 infection.
7.Subjects having received influenza vaccine within the previous six months.
8.Subjects who have received any other vaccine or investigational medicinal product in the preceding 3 months.
9.Subjects with continuing history of alcohol and / or drug abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of immunogenicity and safetyTimepoint: 0,3,7,14,21 & 42 days
- Secondary Outcome Measures
Name Time Method oneTimepoint: Not Applicable