| CTRI Number |
CTRI/2010/091/000591 [Registered on: 15/07/2010] |
| Last Modified On: |
08/10/2014 |
| 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)
|
Comparison of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine versus pre-qualified bivalent oral poliovirus vaccine: a randomized double-blind trial
|
Scientific Title of Study
Modification(s)
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COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIAL |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PBL/CR/2010/02/CT version no 2.0 dated 31-08-10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate,
Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
91-1141679000 |
| Fax |
91-11-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Panacea Biotec Limited |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate,
Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
91-1141679000 |
| Fax |
91-11-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate,
Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
91-1141678000 |
| Fax |
91-11-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Panacea Biotec Limited
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044
|
|
Primary Sponsor
Modification(s)
|
| Name |
Panacea Biotec Limited |
| Address |
Panacea Biotec Limited | B-1 Ext./G-3 |
Mohan co-op. Ind. Estate | Mathura Road, ND-44
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
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|
Countries of Recruitment
Modification(s)
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India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Jain |
Chacha Nehru Bal Chikitsalya |
Avum Anusandhan Kendra,M.G.M Medical College-
Indore
MADHYA PRADESH |
0731-2515251
jainapeksha@hotmail.com |
| Dr. Sharad Agarkhedkar |
DY Patil Medical College |
, Sant Tukaram Nagar, ,Pimpri -411018
Pune
MAHARASHTRA |
09822030122
ashalaka@gmail.com |
| Dr. Ram Dhongade |
Sant Dnyaneshwar Medical Education Research Centre |
695/A Sadashiv Peth,Opp Vijay Talkies Laxmi Road-411030
Pune
MAHARASHTRA |
09822037483
ramdhongade@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutinal Ethics committee, DY Patil Medical College |
Approved |
| Institutional Ethics Committee,MGM Medical College, Indore |
Approved |
| Institutional Ethics Committee,Sant Dnyaneshwar medical Education Research Centre,Pune |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Healthy Human Volunteers |
seroconversion of bOPVs from two different bulk source will be compared in subjects who have received tOPV as birth dose vaccine against poliomyelitis. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
bOPV (from PT BioFarma), |
single dose at 6 to 10 weeks of infants, oral |
| Intervention |
bOPV (from Sanofi Pasteur bulk) |
single dose() at 6 to 10 weeks of infants, oral |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.50 Month(s) |
| Age To |
2.50 Month(s) |
| Gender |
Both |
| Details |
Infants between 6 weeks to 10 weeks of age born healthy (2.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance (<30 km), and not planning to travel away during the entire study period (birth-1 months) |
|
| ExclusionCriteria |
| Details |
Newborns requiring hospitalization, birth weight below 2.50 kg, residence >30 km from study site, or families expecting to be absent during the 30-day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Single dose of bOPV (from Sanofi Pasteur bulk) induces similar levels of seroconversion against poliovirus types 1 or 3, respectively than does one dose of bOPV (from PT BioFarma bulk) |
Sera collected at enrollment and 30 day visit, will be examined for the presence (detectable) or absence of neutralizing antibodies to type 1 and 3 poliovirus serotypes |
|
Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| monitor adverse events following vaccine administration |
follow up of 30 days post vaccination |
|
Target Sample Size
Modification(s)
|
Total Sample Size="272"
Sample Size from India="272"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
19/07/2014 |
| 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
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)
|
No Data has been published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIAL.Primary objective being -The principal purpose of the study is to demonstrate the non inferiority of one doses of bOPV (from Sanofi Pasteur bulk) compared with bOPV (from PT BioFarma bulk).Also adverse events following vaccine administration will be monitored. |