| CTRI Number |
CTRI/2010/091/000204 [Registered on: 15/03/2010] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A Phase-III clinical trial to study the safety and immunogenicity of Bharat Biotech International Limited bivalent Oral Poliomyelitis Vaccine Type-1&3 vs. WHO pre-qualified trivalent polio vaccine in healthy neonates |
Scientific Title of Study
Modification(s)
|
Comparative Study to Evaluate the Safety and Immunogenicity of Bharat Biotech Bivalent Oral Poliomyelitis Vaccine Type1 & 3, Live (Oral) Vs Reference Vaccine. (Non- inferiority trial) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/M1 & M3/05/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Santhosh Kumar |
| Designation |
Asst. Medical Director |
| Affiliation |
|
| Address |
Genome Valley
Shameerpet
Hyderabad
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
madhusudhansk@bharatbiotech.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Santhosh Kumar M |
| Designation |
Asst. Medical Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech
Genome Valley
Shameerpet
Hyderabad
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
madhusudhansk@bharatbiotech.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Santhosh Kumar M |
| Designation |
Asst. Medical Director |
| Affiliation |
|
| Address |
Bharat Biotech
Genome Valley
Shameerpet
Hyderabad
Hyderabad
ANDHRA PRADESH
500078
India |
| Phone |
914023480567 |
| Fax |
914023480560 |
| Email |
madhusudhansk@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Limited, Genome Valley, Shameerpet, Ranga Reddy (Distict), Hyderabad-500 078. |
|
Primary Sponsor
Modification(s)
|
| Name |
Bharat Biotech International Limited |
| Address |
Genome Valley
Shameerpet
Hyderabad |
| Type of Sponsor |
Other [Biopharmaceutical Company] |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. J. Venkateswara Rao |
1. Gandhi Hospital, Secunderabad |
Professor of Pediatrics, Gandhi Hospital, Secunderabad.,-500003
|
+914027754777
drjvrao@yahoo.co.in |
| Dr Mrs N S Mahantshetti |
2. JNMC-WMKC Womens & Childrens Health Research Institute, Belgaum |
Professor & Head of Paediatrics, JNMC-WMKC Womens & Childrens Health Research Institute,590010
Belgaum
KARNATAKA |
918312471350
918312470759
donejnmc@sancharnet.in |
| Dr. P. Venugopal Rao, |
3. King George Hospital, Visakhapatnam |
Professor of Pediatrics, King George Hospital,-530002
Visakhapatnam
ANDHRA PRADESH |
+91891 2748651
venugopal_kgh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| 1. Human Ethics Committee, Gandhi Hospital |
Approved |
| 2. Ethics Committee, KLE university |
Approved |
| 3. Institutional Ethics Committee, King George Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of poliomyelitis Type 1 & 3 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bivalent Oral Poliomyelitis Vaccine Type 1&3 |
2doses,0.1mL each, 30 days apart |
| Comparator Agent |
Panacea Biotec trivalent Oral Poliovirus Vaccine-Primopol |
2 doses, 0.1mL each, 30 days apart |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
0.12 Day(s) |
| Gender |
Both |
| Details |
1. Written and signed informed consent by subject parents or legally acceptable guardian.
2. Healthy male or female full term neonate aged less than three hours at time of enrollment.
3. The delivery was not high-risk
4. The APGAR score was greater than 7 when measure 1 minute after birth
5. Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion.
6. Family does not plan to move during the study period, and housed not further that 50 km away from the study site.
|
|
| ExclusionCriteria |
| Details |
1) Fever of any origin or infections.
2) Any confirmed or suspected immunosuppressive condition.
3) Any treatment with immunosuppressive or immuno stimulant therapy
4) Use of any marketed or investigational medicine or non-registered drug or vaccine for polio.
5) Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
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|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
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Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare and demonstrate that the Immunogenicity of the Investigational product Bharat Biotech International Limited bivalent Oral Poliomyelitis Vaccine Type1&3 is not clinically inferior to that of WHO pre qualified trivalent OPV vaccine. To assess the antibodies titers of Type 1&3 poliovirus after two doses of bivalent Type 1&3 oral polio vaccine or two doses trivalent oral polio vaccine in healthy subjects. |
Serum Antibody titres at pre vaccination, 30 days after first dose administration and 14 days after second dose administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of two doses of investigational product as compared to control vaccine administered as two doses given 30±2 days apart.
The clinical safety evaluation is based on general examination, local examination and subjective evaluation of adverse events. These will be monitored through out the study period.
|
Throughout the study period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="288"
Sample Size from India="288"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/08/2009 |
| 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
Modification(s)
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Randomized, Multi Center, Double Blind, Comparative Phase III Study to evaluate the Safety and Immunogenicity of Bharat Biotech bivalent Oral Poliomyelitis Vaccine Type 1&3 Vs Pre-Qualified trivalent Oral Polio Vaccine In Healthy Neonates. (Non- inferiority trial) in 288 neonates in three centers all over India. The primary objective is to compare and demonstrate that the immunogenicity of the investigational product is not clinically inferior to that of WHO pre qualified trivalent OPV vaccine. By the assessment of antibodies titers for Type 1&3 poliovirus after two doses of bivalent Type 1&3 Oral Polio Vaccine or two doses trivalent Oral Polio Vaccine in healthy neonates. The secondary objective is to evaluate the safety, local and systemic reaction of two doses of test vaccine as compared to WHO pre qualified trivalent OPV vaccine administered as two doses, given 30±2 days apart. |