A Phase I clinical trial to assess safety and immune response of Influenza vaccine of Serum Institute of India Limited in Adults.

Phase 1

Completed

• Conditions: Prevention of seasonal influenza infection

• Registration Number: CTRI/2011/09/002033
• Lead Sponsor: Serum Institute of India Ltd Pune India

Brief Summary

This is a Phase I,observer-blind, randomized, active-controlled, parallel group, clinical studyto evaluate the safety and immunogenicity of SII LAIV in 40 adults. There will be two study groups. Subjects in each age group willreceive single dose of 0.5 ml of formulationA or B of SII LAIV on Day 0. Vitalswill be assessed during the screening and 30 minutes after vaccination. Allthese subjects will be followed for 42 days for safety and immunogenecity.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-27
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Normal healthy subjects of 18-49 years age.

Exclusion Criteria

• Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs.
• Pregnancy and breastfeeding women 4.
• Subject participating in other clinical trial 5.
• Altered immune status.
• Acute febrile illness or acute infectious disease.
• Any nasal pathology.
• History of allergic reaction.
• History of serious chronic illness.
• Guillain-Barré Syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety- solicited, unsolicited, serious adverse events and new onset chronic medical conditions	Day 0,Day 7, Day 21 and Day 42

Secondary Outcome Measures

Name	Time	Method
Seroconversion	On day 7 & day 21

Trial Locations

Locations (1)

Lambda Therapeutic Research Limited; 🇮🇳 Ahmadabad, GUJARAT, India

Lambda Therapeutic Research Limited

🇮🇳Ahmadabad, GUJARAT, India

Dr Manjunath K

Principal investigator

79-40202052

manjunathk@lambda-cro.com