| CTRI Number |
CTRI/2017/10/010104 [Registered on: 16/10/2017] Trial Registered Prospectively |
| Last Modified On: |
07/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial on Liquid Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to compare vaccine non-inferiority with ROTASIIL vaccine in healthy children in India |
|
Scientific Title of Study
|
A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) To Evaluate Lot-To-Lot Consistency and to Compare Non-Inferiority with ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ROTA:06 Version 2.0 Dated 14 July 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602384 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajjad Desai |
| Designation |
Deputy Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602781 |
| Fax |
|
| Email |
sajjad.desai@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, hadapsar, Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, hadapsar, Pune 411028 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay K Lalwani |
Bharati Vidyapeeth Medical College and Hospital, Pune |
Department of Pediatrics, Bharti Hospital & Research Centre, Katraj, Dhankawadi,
Pune, Maharashtra-411043
Pune
MAHARASHTRA |
020-24372789
researchpedpune@gmail.com |
| Dr Dinesh Kumar |
Government Medical College, Jammu |
Department of Community Medicine,
Government Medical College,
Bakshi Nagar, Jammu – 180001
Jammu
JAMMU & KASHMIR |
0191-2585635
dineshgmcjamcmcl@gmail.com |
| Dr Chandra Mohan Kumar |
Hakeem Abdul Hameed Centenary Hospital |
Department of Paediatrics,
Hamdard Institute of Medical Sciences and Research Associated Hakeem Abdul Hameed Centenary Hospital
New Delhi
DELHI |
9810730206
drcmkumar.himsr@gmail.com |
| Dr Ritabrata Kundu |
Institute of Child Health, Kolkata |
Department of Pediatrics,
11 Dr. Biresh Guha Street,
Kolkata, West Bengal- 700017
Kolkata
WEST BENGAL |
033-22905626
rkundu22@gmail.com |
| Dr Veena Kamath |
Kasturba Medical College, Manipal, |
Centre for Vaccine Studies, Prasanna School of
Public Health, Manipal University, Manipal, Karnataka, PIN-576 104
Udupi
KARNATAKA |
0820-2922324
veenak@manipal.edu |
| Dr Abhishek Raut |
Mahatma Gandhi Institute of Medical Sciences, Sewagram, |
Department of community Medicine,
Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram, District – Wardha (Maharashtra),Pin – 442102
Nagpur
MAHARASHTRA |
07152284341
abhishekvraut@gmail.com |
| Dr Madhu Gupta |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of Community Medicine, School of
Public Health, Post Graduate Institute of Medical
Education and Research, Chandigarh – 160012
Chandigarh
CHANDIGARH |
9914208226
madhugupta21@gmail.com |
| Dr Padmasani Venkat Raman |
Sri Ramachandra Medical Centre, Chennai |
Department of Pediatrics,
No. 1, Ramachandra Nagar, Porur, Chennai,
Tamil Nadu -600116
Chennai
TAMIL NADU |
044-24890002
padmasani2001@yahoo.com |
| Dr Anand Kawade |
Vadu Rural Health Program |
KEM Hospital Pune Ankit Shirdi Sai Baba Rural Hospital, A/P - Vadu Budruk, Taluka – Shirur, District, Pune – 412216
Pune
MAHARASHTRA |
02137-252234
askawade@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee, Institute of Child Health |
Approved |
| Institutional Ethics Committee Government Medical College, Jammu |
Submittted/Under Review |
| Institutional Ethics Committee PGIMER |
Submittted/Under Review |
| Institutional Ethics Committee, Bharathi Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee, KEM Hospital and Research Center, Pune |
Approved |
| Institutional Ethics Committee, Sri Ramachandra Medical College and Research Institute |
Approved |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
| Mahatma Gandhi Institute of Medical Sciences Institutional Ethics Committee |
Approved |
| Manipal University Ethics Committee, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rotavirus Gastroenteritis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LBRV-PV
(Test Vaccine three lots) |
Liquid, ready to use formulation of live attenuated human-bovine reassortant pentavalent rotavirus vaccine (BRV-PV) based on the UK bovine rotavirus and five human rotavirus strains (G1, G2, G3, G4, and G9), at a dosage of ≥ Log105.6 fluorescent focus units (FFU) / Serotype / Dose of 2 ml.
Manufactured by the Serum Institute of India Pvt. Ltd., India
|
| Comparator Agent |
ROTASIIL
[Lyophilized BRV-PV (Active Control)] |
Lyophilized formulation of live attenuated human-bovine reassortant pentavalent rotavirus vaccine (BRV-PV) based on the UK bovine rotavirus and five human rotavirus strains (G1, G2, G3, G4, and G9), at a dosage of ≥ Log105.6 fluorescent focus units (FFU) / Serotype / Dose.
Buffered Diluent: 2.5 ml Citrated Sodium Bicarbonate containing 25.6 g of sodium bicarbonate and 9.6 g citric acid per liter.
Manufactured by the Serum Institute of India Pvt. Ltd., India |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1. Healthy infants as established by medical history and clinical examination before entering the study.
2. Age: 6-8 weeks at the time of enrollment.
3. Parental ability and willingness to provide informed consent.
4. Parent who intends to remain in the area with the child during the study period. |
|
| ExclusionCriteria |
| Details |
1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
2. Presence of fever on the day of enrollment (temporary exclusion).
3. Presence of acute disease at the time of enrollment (temporary exclusion).
4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants. |
28 days post dose 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception. |
Throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= "1500"
Final Enrollment numbers achieved (India)="1500" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/10/2017 |
| Date of Study Completion (India) |
25/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is designed as a phase II/III, open-label, multicenter,
randomized, active controlled trial with four groups of infants (n=375 per
group) receiving one of three different lots of LBRV-PV or ROTASIIL, to compare
immunogenicity of the two formulations and to assess LBRV-PV’s production
consistency. Three doses of LBRV-PV / ROTASIIL will be administered 4 weeks
apart, with the first administration given at 6-8 weeks (42-56 days, both inclusive) of age. |