REFCTRI/2009/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Thu, 03 May :30:57 GMT) CTRI Number CTRI/2009/091/ [Registered on: 25/01/2010] - Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Vaccine Randomized, Parallel Group, Active Controlled Trial Clinical Study to compare and evaluate the immunogenicity and reactogenicity of Inactivated Polio Vaccine of Panacea Biotec Ltd. with Imovax Polio of Sanofi Pasteur Pvt Ltd. in Healthy infants. An Open Labelled, Randomized, Multicentre, Comparative study to evaluate the immunogenicity and reactogenicity of Inactivated Polio Vaccine (Panacea Biotec Ltd.)with Imovax Polio(Inactivated Poliomyelitis Vaccine, Sanofi Pasteur Pvt Ltd)in infants. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) PBL/CR/ /CT Protocol Number Details of Principal Investigator Senior Vice President-clinical Research Clinical Research Department, Panacea BIotec Limited, MCIE New Delhi Details Contact Person (Scientific Query) Senior Vice President-clinical Research Clinical Research Department, Panacea BIotec Limited, MCIE New Delhi Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee > Panacea Biotec Ltd. Type of Sponsor NIL List of Countries of Principal Investigator Dr. Sharad Agarkhedkar Dr J. Venkateswara Rao Dr. A. Amaresh Dr Hemant Jain Dr. Ram Dhongade Dr. Padmasani Ramanan Source of Monetary or Material Support Primary Sponsor Details Panacea Biotec Ltd B-1 Ext. / G-3, Mohan Coop Indl EstateMathura Road, Pharmaceutical industry-n of Site Site Phone/Fax/ Dr.D.Y.Patil Medical College Gandhi Hospital Sant Tukaram Nagar,, Pimpri MAHARASHTRA Dept. of Paediatrics,,Mu sheerabad, Hyderabad ANDHRA PRADESH Institute of Child Health Niloufer Hospital,,Red Hills, Hyderabad ANDHRA PRADESH M.G.M.Medical College Department of Pediatrics,Chacha Nehru Bal Chikitsalya,,Chacha Nehru Bal Chikitsalya, Indore MADHYA PRADESH Sant Dnyaneshwar Medical Education Research Centre Sri Ramachandra Medical College and Research Institute, 695/A Sadashiv Peth,,Opp Vijay Talkies Laxmi Road MAHARASHTRA Sri Ramachandra Unive rsity,,porur, Chennai TAMIL NADU ashalaka@gmail.com dr_jvrao@yahoo.co.in adyaramaresh@yahoo. com jainapeksha@hotmail.c om ramdhongade@hotmail. com padmasani2001@yaho o.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee, Osmania Medical College, Hyderabad Ethics Committee, sant Dnyaneshwar Medical Education Research Approved 22/06/2009 Not Available Approved 14/06/2009 Not Available page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Centre, Human Ethics Committee, gandhi Hospital, Secundrabad Institutional Ethics Committee, Padmashree Dr. D Y Patil medical College, Insttutional Ethics Committee, Sri ramachandra University, Chennai MGM Medical College & Associate hospital Society Status Approved 09/07/2009 Not Available Approved 02/07/2009 Not Available Approved 16/06/2009 Not Available Approved 27/06/2009 Not Available Date Approved/Obtained 19/01/2010 Health Type Healthy Human Volunteers Condition Primary immunization of infants for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3 in infants Type Details Intervention Comparator Agent Age From Age To Gender Details Inactivated Polio Vaccine (Panacea Biotec Limited) IMOVAX POLIO (Sanofi Pasteur Pvt. Ltd.) 0.00 Day(s) Day(s) Both Inclusion Criteria Three doses(0.5 ml each) at 6, 10 and 14 weeks of age. Three doses at 6, 10 and 14 weeks of age. 1.Newborn infants whose parent/lar is willing to give written informed consent/oral witnessed consent prior to the study entry. 2.Born at full term pregnancy (more than eaqual to 37 weeks) with a birth weight more than or equal to 2.5 Kg. 3.Judged to be able to attend all scheduled study visits and to comply with trial procedures. 4.Overall in good general health in opinion of the investigator as determined by medical history and physical examination Exclusion Criteria Details Exclusion Criteria 1.Subject is less than 6 weeks or more than 7 weeks of age. 2.Known history of allergy or hypersensitivity to study immunization or any component of the study vaccines. 3.Prior history of immunization with either with OPV, IPV. 4.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis. 5.Prior history of infection with or immunization against pertussis, tetanus, diphtheria, hepatitis B or H. Influenzae. 6.Known history of any convulsions or neurological illness. 7.Suspected or known to be immunocompromised or HIV positive or on immunosuppressant therapy*. 8.Known history of administration of blood products, high doses of corticosteroids, cytotoxic agents or page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Permuted block randomization, fixed Not Applicable Open Label radiotherapy. 9.Presented with previous history of a disease potentially related to poliomyelitis. 10.Recorded body temperature > 38 degree Celsius within the past 3 days. 11.Within the past 7 days, have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy (Enrolment deferred in the presence of any acute illness, including febrile illness). 12.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) such that it would endanger the volunteer?s well being or is likely to result in non conformance to the protocol or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 13.Thrombocytopenia or a bleeding disorder. 14.Planning to leave the area of the study site before completion of the study. * Based on medical history, clinical judgment and available Lab tests. Primary Outcome Outcome Timepoints GMTs and seroprotection rate as measured by levels of antibodies to each of the three polio serotypes after three doses. Serum Antibody titres pre vaccination and one month after completion of three dose primary vaccination series. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Incidences of local and systemic reactions Throughout the study duration. occurring during the study period will be compared between test and comparator vaccine. Proportion of subjects achieving serorotection/seroresponse against all antigens for concomitantly administered Easyfive Vaccine (DTwP-Hib-HB) Lot-to-lot consistency of three lots of the IPV (Panacea Biotec Ltd.) vaccine in terms of immunogenicity of each antigen. Total Sample Size=624 Sample Size from =624 25/01/ /02/2010 Years=0 Months=9 Days=0 Not Applicable Completed NIL Antibody titres before and one month after primary vaccination series. Antibody titres before and one month after primary vaccination series for three vaccine batches of IPV of Panacea Biotec. Open labeled, randomized, comparative, multicentre study to compare the immunogenicity and reactogenicity of IPV of Panacea Biotec Ltd. with WHO pre-qualified Imovax Polio of Sanofi Pasteur Ltd. Primary objective of the study is to demonstrate non-inferiority of the test vaccine to the reference vaccine, with 90% power and alpha set at The study will also evaluate the page 4 / 5

5 Powered by TCPDF ( REFCTRI/2009/ common local and systemic reactogenicity and lot-to-lot consistency of test vaccine. page 5 / 5