| CTRI Number |
CTRI/2019/03/017934 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
29/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ROTAVAC 5CM Lot to Lot consistency phase IV study |
|
Scientific Title of Study
|
Phase IV, Randomized, Multi Centre, Open label Study to Evaluate Lot to Lot consistency of Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine) as a 3-Dose Series.
|
| Trial Acronym |
ROTAVAC 5CM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/ROTAVAC 5CM/IV/2018; version1.0 dated 01/10/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Mohan |
| Designation |
Whole-time Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Genome Valley, Shameerpet
Medchal
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480344 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Mohan |
| Designation |
Whole-time Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Genome Valley, Shameerpet
Medchal
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480344 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Mohan |
| Designation |
Whole-time Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Genome Valley, Shameerpet
Medchal
TELANGANA
500078
India |
| Phone |
914023480567 |
| Fax |
914023480344 |
| Email |
kmohan@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Limited |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Limited |
| Address |
Genome Valley, Shameerpet, Telangana |
| 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 Srikanth |
Gandhi Medical College/Gandhi Hospital |
study room,Department of Pediatrics, 1st floor,Gandhi Hospital, Musheerabad, Secunderabad, Telangana-500003
Hyderabad
TELANGANA |
9490141350
dr.srilu84@gmail.com |
| Dr Sumantra Sarkar |
IPGME&R and SSKM Hospital |
Ground floor, Room No 7, 244, AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL |
9433090390
drsumantrasarkar@gmail.com |
| Dr Vasant M Khalatkar |
Khalatkar Hospital |
R-29,Reshimbag,Umrer Road,sakkardara,Nagpur-440009
Nagpur
MAHARASHTRA |
9823044438
07122740600
drashishtajne@yahoo.com |
| Dr Amit Chawla |
Prakhar Hospital Pvt. Ltd |
8/219, Arya nagar, kanpur
Kanpur Nagar
UTTAR PRADESH |
7906261455
pi.clintrial@gmail.com |
| Dr Manish Narang |
University college of medical sciences& Guru Teg bahadur Hospital |
UCMS and GTB hospital, Dilshad Garden-Delhi-110095
New Delhi
DELHI |
9811036569
00911122590495
manish_2710@yahoo.com |
| Dr M Giridora |
Victoria Government hospital |
old town,Visakhapatnam 530001
Visakhapatnam
ANDHRA PRADESH |
9966799995
drgiridoract@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee-Prakhar Hospital Pvt.Ltd |
Approved |
| Guru Teg Bahadur Ethics Committee(GTBHEC) |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, KGH |
Approved |
| IPGME&R Research oversight committee |
Approved |
| Jasleen Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preventions of gastroenteritis due to rotavirus infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ROTAVAC 5CM |
Vero cell derived Rotavirus 116 Bulk, Live Attenuated
NLT 10 5.0 FFU
Three treatment arms in 1:1:1 ratio |
|
|
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
3. Weight: ≥2.5 kgs at birth
4. Infants received age-appropriate UIP vaccines till enrolment and during the study.
5. Parental ability and willingness to provide informed consent.
6. Parent who intends to remain in the area with the subject during the study period.
|
|
| ExclusionCriteria |
| Details |
Any of the following criteria will preclude the participant from being enrolled in the study:
1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
2. Presence of fever on the day of enrolment (temporary exclusion).
3. Concurrent participation in another clinical trial.
4. Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child’s health or is likely to result in non-conformance to the protocol.
5. History of congenital abdominal disorders, intussusception, abdominal surgery.
6. Household contact with an immunosuppressed individual or pregnant woman.
7. Prior receipt of rotavirus vaccine.
8. A known sensitivity or allergy to any components of the study vaccines.
9. Major congenital or genetic defect.
10. History of persistent diarrhea (defined as diarrhea of more than 14 days).
11. Subject’s parents not able, available or willing to accept active follow-up by the study staff.
12. Has received any immunoglobulin therapy and/or blood products since birth.
13. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study, at the discretion of the principal investigator.
14. History of any neurologic disorders or seizures.
15. Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence.
16. A subject’s parent’s/legally acceptable representative’s inability to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Establish Lot Consistency across production lots of ROTAVAC 5CM.
2.GMTs of serum anti rotavirus IgA antibody with three production lots of ROTAVAC 5CM measured on 4-6 weeks after administering of 3rd dose |
Day 0 & Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.4 fold seroconversion
2. Sero response to childhood vaccines
3. serveilance forsolicited and unsolicited Aes & SAEs throughout studies |
Day 0 to Day 84 |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="384" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2019 |
| Date of Study Completion (India) |
21/11/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is multicenter, open label, randomised clinical trial. Infants of 6-8weeks of age will randomly be assigned to receive 3 doses of ROTAVAC 5CM(3 Production lots) to evaluate lot consistency.
Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain information on solicited adverse events(Reactogenicity). Surveillance for unsolicited AEs for all participants will be conducted from the between first dose and 4-6weeks after the 3rd dose. Surveillance for SAEs for all participants will be conducted from the time between first dose and 4-6weeks after the 3rd dose. |