| CTRI Number |
CTRI/2011/04/001700 [Registered on: 27/04/2011] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An clinical trial to assess the immunogenicity and safety of Influenza Vaccine in healthy adult persons |
|
Scientific Title of Study
|
An open label, multicentric, phase I/II clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent in healthy adult subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 10-18A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868211 |
| Fax |
079-26862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmedabad - 380015. Gujarat. India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raj Bhagat |
Dr. Bhagats Allergy Asthma Clinic & Respiratory Care Centre |
"Pathik", Dashaporwad society, Behind Paldi Bus stop, Ahmedabad - 380007.
Ahmadabad
GUJARAT |
079-26574746
rajpurvi@yahoo.com |
| Dr Praveen Garg |
Shashwat Hospital & Research Centre |
323 – Satyam Mall, Opp. Kameshwar School, Jodhpur cross, Ahmedabad
Ahmadabad
GUJARAT |
079-26741500
praveen_k_garg@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC - Aditya for Dr. Praveen Garg |
Approved |
| IEC - Aditya for Dr. Raj Bhagat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Seasonal Influenza Infection in Healthy adult volunteers |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent |
0.5 ml single dose on Day 0 by intramuscular injection in deltoid muscle |
| Comparator Agent |
None |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of seroconversions or significant increase in anti-haemagglutinin antibody titre
2. Increase in Geometric Mean Titre (GMT)
3. The proportion of subjects achieving an HI titre more than or equal to 1:40 |
Day 0 & Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety Assessments |
Day 0, 7, 21 & 42 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/04/2011 |
| 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="6"
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
|
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.
|