| CTRI Number |
CTRI/2014/01/004339 [Registered on: 23/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study to assess the immune response and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 15-18 months |
|
Scientific Title of Study
|
A randomized, open label, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 15-18 months |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 12-02Ver01dated14/06/2013 |
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 - 380015.
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926868910 |
| 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 - 380015.
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
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 - 380015
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868924 |
| Fax |
07926868910 |
| Email |
jayeshsanmukhani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus-PTC, Sigma Commerce Zone,
B/H ISCON Temple, Near Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bakul B Javadekar |
Department of Paediatrics, SSG Hospital |
Ward No. 17 (First Floor).
S.S.G. Hospital, Raopura,
Vadodara - 390001, Gujarat, India.
Vadodara
GUJARAT |
9925014448
bjavadekar@rediffmail.com |
| Dr Neeta Hanumante |
Department of Pediatrics, Bharati Hospital & Research Centre, Bharati Vidyapeeth |
Bharati Hospital & Research Centre,
Bharati Vidyapeeth Deemed University Medical College and Hospital.
Pune Satara Road, Katraj-Dhankawadi,
Pune - 411 043, Maharashtra
Pune
MAHARASHTRA |
02024364308
researchpedpune@gmail.com |
| Dr Baldev Prajapati |
Department of Pediatrics, GCS Medical College & Hospital |
Department of Pediatrics,
GCS Medical College & Hospital, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road,
Ahmedabad – 380013
Ahmadabad
GUJARAT |
9824039376
baldevprajapati55@gmail.com |
| Dr Uma Siddhartha Nayak |
Department of Pediatrics, GMERS Medical College & Government Hospital |
GMERS Medical College & General Hospital, Gotri, Vadodara 390021, Gujarat, India
Vadodara
GUJARAT |
09327214065
umasnayak@gmail.com |
| Dr Rajesh N Joshi |
Department of Pediatrics, GMERS Medical College and Government Hospital |
GMERS Medical College, Sola. S.G. Highway,
Near New Gujarat high court, Ahmedabad-380061,
Gujarat, India
Ahmadabad
GUJARAT |
9879513412
rnjoshi@gmail.com |
| Dr Sharad Agarkhedkar |
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical college and Hospital |
Padmashree Dr. D. Y. Patil Medical college and Hospital,
Pimpri, Pune – 18
Pune
MAHARASHTRA |
09011090078
ashalaka@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr. D. Y. Patil Vidyapeeth, Pune, Pimpri, Pune |
Approved |
| Ethics committee GMERS Medical College, Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad-380061, Gujarat |
Approved |
| Institutional Ethics Committee (Institutional Review Board) GMERS Medical College Gotri, Gotri Road, Vadodara 390021, Gujarat India |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee on human Research, Medical College Baroda |
Approved |
| Institutional Ethics Committee, GCS Medical college, Hospital & Research Centre, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Active immunization for the prevention of disease caused by Measles, Mumps and Rubella viruses. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Measles, Mumps and Rubella vaccine (Live)-Single dose (Freeze-dried) of M/s Cadila Healthcare Ltd.; Measles, Mumps and Rubella vaccine (Live)-Multi dose (Freeze-dried) of M/s Cadila Healthcare Ltd. |
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 on 0 day; Each subject will be given a single dose of 0.5ml vaccine from multidose vial given as a subcutaneous injection in the upper arm on 0 day. |
| Comparator Agent |
NIl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Month(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
1.Healthy pediatric subjects of either sex aged 15 months to 18 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 vaccines; hypersensitivity to neomycin.
2.Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement.
3.Subjects having received measles vaccine less than 3 months back.
4.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination.
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 products or immunoglobulins parenterally during the preceding 3 months.
8.Subjects with any other clinically significant concurrent illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary immunogenicity criteria will be the seroconversion rate for measles, mumps and rubella |
42 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary immunogenicity criteria will be the post-vaccination geometric mean titers (GMTs) of antibodies to measles, mumps and rubella |
42 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/01/2014 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, open label, parallel group, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. (CHL) in healthy paediatric subjects aged 15-18 months. Hundred subjects will be randomized to receive MMR vaccine from either a single dose vial or a multidose vial. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination. The primary immunogenicity criteria will be the seroconversion rate which would be estimated as follows: 1.The percentage of subjects who had been seronegative before vaccination and who developed antibody concentrations of ≥ 200 Milli International Unit (mIU)/ml for measles, ≥ 8 ELISA units (U)/ml for mumps and ≥ 8 International Unit (IU)/ml for rubella 42 days following vaccination. 2. The percentage of subjects who were already seropositive for measles / mumps / rubella at the time of immunization and developed a ≥ 4 fold increase in the respective antibody titers 42 days following vaccination. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study |