| CTRI Number |
CTRI/2010/091/000182 [Registered on: 02/03/2010] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the immunogenicity and safety of Inactivated Influenza Vaccine in healthy adult volunteers |
Scientific Title of Study
Modification(s)
|
An open label, phase II/III clinical study to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine) in healthy adult volunteers |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-17A |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Cadila Healthcare Ltd
Zydus Tower
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd
Zydus Tower
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower Satellite Cross Roads Ahmedabad GUJARAT
380015 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Raj Bhagat |
Dr. Bhagat?s Allergy, Asthma Clinic & Resp. Care Centre, Ahmedabad |
Dr. Bhagat?s Allergy, Asthma Clinic & Resp. Care Centre,?Pathik?, Dashaporwad Society, Gujaranwala Flats Land, Paldi-380007
Ahmadabad
GUJARAT |
079-26574746
rajpurvi@yahoo.com |
| Dr. Puneet Rijhwani |
Mahatma Gandhi National Institute of Medical Sciences, Jaipur |
Department of Medicine,Mahatma Gandhi National Institute of Medical Sciences-
Jaipur
RAJASTHAN |
puneet284@rediffmail.com |
| Dr. Vikas G. Pai |
Pai Clinic & Diagnostic Centre, Pune |
Pai Clinic & Diagnostic Centre,Abhinav Apartment, 778/B1, Shivajinagar, Next to Congress House-411005
Pune
MAHARASHTRA |
020-25534404
020-25534944
paivikas@indiatimes.com |
| Dr Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
Shashwat Hospital & Research Centre,323 ? Satyam Mall, Jodhpur Cross-roads-380015
Ahmadabad
GUJARAT |
9825155017
praveen_k_garg@yahoo.com |
| Dr. V. Shankar |
Standard Laboratory and Polyclinic, Bangalore |
Standard Laboratory and Polyclinic,23, 1st Floor, 2nd Main Road, Vyalikaval-560003
Bangalore
KARNATAKA |
080-23440517
yannurshankar@gmail.com |
| Dr. Dinesh V. Kamath |
Sudeep Diabetes Care Centre, Bangalore |
Sudeep Diabetes Care Centre,No. 84, Soundarya Paramount, 5th Cross, Malleswaram-560003
Bangalore
KARNATAKA |
dineshvkamath@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya (DrDineshKamathBangalore) |
Approved |
| Independent Ethics Committee - Aditya (IECPermissionDrPraveenGargAhmedabad) |
Approved |
| Independent Ethics Committee - Aditya (IECPermissionDrRajBhagatAhmedabad) |
Approved |
| Independent Ethics Committee - Aditya (IECPermissionDrVShankarBangalore) |
Approved |
| Institutional Ethical and Research Committee - Mahatma Gandhi Medical College & Hospital, - DrPuneetRijhawaniJaipur |
Approved |
| Mahalasa Independent Ethics Committee (ECPermission (DrVikasPaiPune) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of H1N1 (2009) Influenza |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Inactivated Influenza Vaccine (Whole Virion) IP (Pandemic Influenza (H1N1) 2009 Monovalent Vaccine) |
0.5 ml single intramuscular (I.M.) dose of the vaccine |
| Comparator Agent |
None |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Assessment of immunogenicity and safety |
0,3,7,14,21 & 42 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| None |
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/02/2010 |
| 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
Modification(s)
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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.. |