An clinical trial to assess the immunogenicity and safety of Influenza Vaccine in healthy adult persons

Phase 1/2

Completed

• Conditions: Prevention of Seasonal Influenza Infection in Healthy adult volunteers; Encounter for immunization,

• Registration Number: CTRI/2011/04/001700
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, single treatment arm study to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP,Trivalent given as 0.5 ml single I.M. injection in healthy adult subjects that will be conducted  in India with a follow-up period of 42 days. The primary outcome measure will be the immunogenicity assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-28
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 1.Healthy volunteers of the age 18-60 years age.
• 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.Informed consent of the subject/relative.

Exclusion Criteria

• 1.Pregnancy & Lactation.
• 2.Subjects with a history of anaphylaxis or serious reactions to vaccines; influenzal viral protein, egg proteins, neomycin or polymyxin.
• 3.Subjects who are taking immunostimulant therapy or immunosuppressant medications.
• 4.Subjects who are known to be suffering from diseases which can affect immune competence.
• 5.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
• 6.Subjects who have recently had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy.
• 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 any other clinically significant concurrent illness.
• 10.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
1.Number of seroconversions or significant increase in anti-haemagglutinin antibody titre	Day 0 & Day 21
2.Increase in Geometric Mean Titre (GMT)	Day 0 & Day 21
3.The proportion of subjects achieving an HI titre more than or equal to 1:40	Day 0 & Day 21

Secondary Outcome Measures

Name	Time	Method
Safety Assessments	Day 0, 7, 21 & 42

Trial Locations

Locations (2)

Dr. Bhagats Allergy Asthma Clinic & Respiratory Care Centre; 🇮🇳 Ahmadabad, GUJARAT, India

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

Dr. Bhagats Allergy Asthma Clinic & Respiratory Care Centre

🇮🇳Ahmadabad, GUJARAT, India

Dr Raj Bhagat

Principal investigator

079-26574746

rajpurvi@yahoo.com