CTRI Number CTRI/2011/09/002033 [Registered on: 30/09/2011] Trial Registered Retrospectively
Last Modified On: 03/01/2012
Post Graduate Thesis No
Type of Trial Interventional
Type of Study
Vaccine
Study Design Randomized, Parallel Group Trial
Public Title of Study
A Phase I clinical trial to assess safety and immune response of Influenza vaccine of Serum Institute of India Limited in Adults.
Scientific Title of Study
A Phase I clinical trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in Adults.
Trial Acronym
Secondary IDs if Any
Secondary ID Identifier
SIV- 00/11
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Dr Manjunath K
Designation Assistant General Manager
Affiliation Lambda Therapeutic Research Limited
Address Lambda Therapeutic Research Limited,
Near Silver Oak Club, S.G. Highway,
Ahmedabad, Gujarat, India.
Phone 91-79-40202052
Fax 91-79-40202022
Email manjunathk@lambda-cro.com
Details of Contact Person
Name
Dr Prasad Kulkarni
Designation Medical Director
Affiliation Serum Institute of India Ltd.
Address Serum Institute of India Ltd.
212/2, Hadapsar,
Pune – 411028,
Maharashtra, India.
Phone 91-20-26602384
Fax 91-20-26993945
Email drpsk@seruminstitute.com
Details of Contact Person
Name Dr Prasad Kulkarni
Designation Medical Director
Affiliation Serum Institute of India Ltd.
Address Serum Institute of India Ltd.
212/2, Hadapsar,
Pune – 411028,
Maharashtra, India.
Phone 91-20-26602384
Fax 91-20-26993945
Email drpsk@seruminstitute.com
Source of Monetary or Material Support
Serum Institute of India Ltd.
Primary Sponsor
Name Serum Institute of India Ltd Pune India
Address Serum Institute of India Ltd.
212/2, Hadapsar,
Pune – 411028,
Maharashtra, India.
Type of Sponsor Pharmaceutical industry-Indian
Details of Secondary Sponsor
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator Name of Site Site Address Phone/Fax/Email
Dr Manjunath K
Lambda Therapeutic Research Limited
Near Silver Oak Club, S.G. Highway,
Ahmedabad, Gujarat.
91-79-40202052
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status
Independent Ethics Committee- Adithya
Approved
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied
Health Type Condition
Healthy Human Volunteers
Prevention of seasonal influenza infection
Intervention / Comparator Agent
Type Name Details
Intervention
Formulation A of Live attenuated Influenza virus vaccine
Single dose of 0.5ml by Intranasal route, Influenza vaccine containing Dose of Not less than log 7 of H1N1 and H3N2 and dose of not less than log 6.5 influenza B virus.
Comparator Agent
Formulation B of Live attenuated Influenza virus vaccine
Single dose of 0.5ml by Intranasal route, Influenza vaccine containing Dose of Not less than log 6.5 of H1N1 and H3N2 and dose of not less than log 6 influenza B virus.
Inclusion Criteria
Age From 18.00 Year(s)
Age To 49.00 Year(s)
Gender Both
Details Normal healthy subjects of 18-49 years age
ExclusionCriteria
Details 1. Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs. 3. Pregnancy and breastfeeding women 4. Subject participating in other clinical trial 5. Altered immune status. 6. Acute febrile illness or acute infectious disease. 7. Any nasal pathology. 8. Asthma. 9. History of allergic reaction. 10. History of serious chronic illness. 11. Guillain-Barré Syndrome.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome TimePoints
Safety- solicited, unsolicited, serious adverse events and new onset chronic medical conditions
Day 0,Day 7, Day 21 and Day 42
Secondary Outcome
Outcome TimePoints
Seroconversion
On day 7 & day 21
Target Sample Size
Total Sample Size= "40"Sample Size from India= "40" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)= ""
Phase of Trial
Phase 1
Date of First Enrollment (India)
27/09/2011
Date of Study Completion (India) Date Missing
Date of First Enrollment (Global) Date Missing
Date of Study Completion (Global) Date Missing
Estimated Duration of Trial
Years= "0"Months= "2"Days= "0"
Recruitment Status of Trial (Global)
Modification(s)
Not Applicable
Recruitment Status of Trial (India) Completed
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a Phase I,
observer-blind, randomized, active-controlled, parallel group, clinical study
to evaluate the safety and immunogenicity of SII LAIV in 40 adults. There will be two study groups. Subjects in each age group will
receive single dose of 0.5 ml of formulation
A or B of SII LAIV on Day 0. Vitals
will be assessed during the screening and 30 minutes after vaccination. All
these subjects will be followed for 42 days for safety and immunogenecity.