A clinical trial to study the immunogenicity and safety of Inactivated Influenza Vaccine in healthy adult volunteers

Phase 2/3

Completed

• Conditions: Prevention of H1N1 Influenza; Encounter for immunization,

• Registration Number: CTRI/2010/091/000182
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, multicentric study to assess to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine) given by single intramuscular injection in 200 healthy adult volunteers that will be conducted in India. Assessment of immunogenicity and safety of the vaccine will be carried out over a period of 42 days..

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-28
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 safety	0,3,7,14,21 & 42 days

Trial Locations

Locations (6)

Dr. Bhagat?s Allergy, Asthma Clinic & Resp. Care Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Mahatma Gandhi National Institute of Medical Sciences, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Pai Clinic & Diagnostic Centre, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Standard Laboratory and Polyclinic, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Sudeep Diabetes Care Centre, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Bhagat?s Allergy, Asthma Clinic & Resp. Care Centre, Ahmedabad

🇮🇳Ahmadabad, GUJARAT, India

Dr. Raj Bhagat

Principal investigator

079-26574746

rajpurvi@yahoo.com