| CTRI Number |
CTRI/2015/05/005739 [Registered on: 05/05/2015] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the immune response and safety of Measles vaccine manufactured by Cadila healthcare Ltd. with Measles vaccine manufactured by Serum Institute of India Ltd. in children 9-12 months of age |
|
Scientific Title of Study
|
A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority, phase III clinical study to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 14-05 Version No. 00 dated 02/07/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Senior Manager – New Product Development |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.,
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868924 |
| Fax |
079-26868910 |
| Email |
jayeshsanmukhani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd., SIGMA CommerZone
Near Iscon Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015.
Gujarat, INDIA.
Phone No.: 079-2686-8900
Fax No.: 079-2686-8910 |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
SIGMA CommerZone
Near Iscon Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015.
Gujarat, INDIA.
Phone No.: 079-2686-8900
Fax No.: 079-2686-8910 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeta Hanumante |
Bharati Hospital & Research Centre, Bharati Vidyapeeth |
Room No 11-14, Ground Floor, Paediatric Research Cell, Paediatric OPD, Bharti Hospital
Pune
MAHARASHTRA |
020-24364-308
researchpedpune@gmail.com |
| Dr T Ramesh Babu |
Gandhi General Hospital |
Study Room, First Floor, Department of Pediatrics, Main Building, Gandhi General Hospital, Musheerabad
Hyderabad
ANDHRA PRADESH |
040-27504441
ramesh_ped@yahoo.com |
| Dr Uma Siddhartha Nayak |
GMERS Medical College & Government Hospital, GOTRI |
Room No. 501; 5th Floor, Department of Paediatric, Main Hospital Building, GMERS Medical College
Vadodara
GUJARAT |
09327214065
umasnayak@gmail.com |
| Dr Rajesh N Joshi |
GMERS Medical College and Government Hospital, SOLA |
Room No. 34, Department of Paediatrics, Transit OPD, GMERS Medical College, Sola (SG Highway)
Ahmadabad
GUJARAT |
98795-13412
rnjoshi@gmail.com |
| Dr Ashwani Kumar Sood |
Indira Gandhi Medical College |
Children OPD (Room No.7), A Block, Ground Floor, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH |
9418300888
doc.aksood@gmail.com |
| Dr Nupur Ganguly |
Institute of Child Health |
Room No. 113, Ground Floor, Institute of Child Heath, 11, Dr. Biresh Guha street
Kolkata
WEST BENGAL |
98304-54874
nupur_diya@yahoo.com |
| Dr Pradeep N |
Mysore Medical College and Research Institute and Associated Hospitals |
Immunization Room, Ground floor, OPD building, Cheluvamba Hospital
Mysore
KARNATAKA |
09611898080
drpradeepn80@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee , Indira Gandhi Medical College Situated at Shimla-171001, Himachal Pradesh, India |
Approved |
| Ethics committee GMERS Medical College, Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad-380061, Gujarat |
Approved |
| Ethics Committee, Institute of Child Health, Kolkata, West Bengal |
Approved |
| Institutional Ethics Committee (Institutional Review Board) GMERS Medical College Gotri, Gotri Road, Vadodara 390021, Gujarat |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee, Gandhi Medical College, Musheerabad, Secunderabad, Telangana – 500003 |
Approved |
| Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals, Irwin Road, Mysore, Karnataka 570021 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Active immunization for the prevention of disease caused by Measles virus |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited (Single dose vial) |
Each subject will be given a single dose of 0.5ml vaccine given as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine. |
| Intervention |
Multi-dose vial of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited |
Each subject will be given a single dose of 0.5ml vaccine from multidose vial given as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine. |
| Intervention |
Single-dose vial of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited |
Each subject will be given a single dose of 0.5ml vaccine from single dose vial given as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1.Healthy paediatric subjects of either sex aged 9 months to 12 months.
2.Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child.
3.Parents/guardians with adequate literacy to fill the diary cards |
|
| ExclusionCriteria |
| Details |
1.Subjects with a history of anaphylaxis or serious reactions to other vaccines, gelatin and / or albumin
2.Subjects with a history of previous measles infection or measles vaccination or if they had been exposed# to measles virus within 30 days of trial commencement
3.Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
4.Subjects with an acute febrile illness at the time of randomization
5.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
6.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
7.Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
8.Subjects with any other clinically significant concurrent illness affecting immune response after vaccination |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects who are sero-positive at the end of study in the two groups |
42 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Geometric mean titre of anti-measles antibodies in the two groups at the end of the study |
42 days following vaccination |
| • Sero-conversion rate in subjects who were sero-negative before randomization in the two groups at the end of the study |
42 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="327"
Sample Size from India="327"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2015 |
| 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="8"
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 randomized, single blind, parallel group, multicentre, non-inferiority phase III clinical trial to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months. Three hundred and twenty seven subjects will be randomized to receive either Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose vial) or Measles vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >300 Milli International Unit (mIU)/ml will be considered as sero-positive. The primary efficacy end point will be the proportion of subjects who are sero-positive at the end of study in the two groups. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study |