REFCTRI/2010/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Tue, 19 Dec :36:20 GMT) CTRI Number CTRI/2010/091/ [Registered on: 05/10/2010] - Last Modified On 05/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Observational Cohort Study Single Arm Trial A clinical trial to observe the safety and reactogenicity of pentavalent vaccine, after reconstitution of freeze dried HIB Vaccine with DTwP-rHepB liquid vaccine, before administration. A multicentric open label non-comparative phase-iv observational study to evaluate safety and reactogenicity of BEs reconstituted Pentavalent DTwPrHepB/HIB vaccine in 6-8 week old healthy infants as per routine EPI Immunization Schedule 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) BECT017/DTwP-rHepB+HIB-PIV/CTP-01 Version:01dated: Designation Affiliation Protocol Number Details of Principal Investigator DrTSAKishore Deputy General Manager Biological E. Limited Phone Fax Designation Affiliation Overall Trial Coordinator, Biological E. Limited, 18/1&3, Azamabad, India kishore.tsa@biologicale.co.in Details Contact Person (Scientific Query) DrTSAKishore Deputy General Manager Biological E. Limited Phone Fax Designation Affiliation Dy. General Manager, Clinical Affairs & Pharmacovigilance, Biological E. Limited, 18/1&3, Azamabad, India kishore.tsa@biologicale.co.in Details Contact Person (Public Query) Mr Pawan Bhusari Sr.Manager Sristek Consulting Pvt. Ltd Sr.Manager-Clinical Operations, Sristek Consulting Pvt. Ltd, DLF Cyber city Block-3, 8th Floor, Gachibowli page 1 / 9

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax Source of Monetary or Material Support > Biological E. Limited, 18/1&3, Azamabad, A.P. India Type of Sponsor None List of Countries India of Principal Investigator Dr. Rahul Jahagirdar Dr. Narsing Rao Primary Sponsor Details Biological E Limited 18/1&3, Azamabad, A.P. India Pharmaceutical industry-indian None of Site Site Phone/Fax/ 2-3, Vaidehi Co-op, Hsp. Soc Abhinay Mothers & Child Clinic S No123/A-B, MIT College Rd, Paud Rd,Kothrud, Opposite to srinivasa Hospital,Santosh Nagar, - Dr. N V Bhavani Amrutha Clinic, Plot no.130,srinagar Colony Dr. Santi Ger Dr. Srikrishna Dr.Pradeep Bhattacharjee Dr. Dhyanchand V Charles Dr. Ravindra Kumar Annapurna Niramoy Clinic Balgopal Children Clinic, Banerjee Medical, Clinisearch Diabetes Centre Bazarpara, Uluberia,,H owrah Road no: 3, Erraggadda, Near Gokul Theater,- Rabindra Nagar,, No.416, 4th Cross, 2nd Block,Kalyan Nagar #4C - 426, 4th Cross, 2nd Block,Kalyan Nagar dr_rahul@hotmail.com jillallanrao@yahoo.com drsantiger@yahoo.com drsskrishna@rediffmail. com p.ku.bhattacharjee@gm ail.com dhyanchandc@yahoo.c om ravihoodi@yahoo.com page 2 / 9

3 Dr. Padmavathi. N Diagnostic Centre, #1423, Kullappa Layout, Kullappa Circle,,St Thomas town Post, Dr. Santanu Guria Bhupati Medical Bagnan, Howrah,, Dr.Arif Aziz Nathani Children Care Clinic /A/107/C/12/A,N ear New Habeeb Medical Hall,Phool Bagh, Misti Gunj- Dr. Anil kumar Ghosh City Chemist Barasat champadali More,,Barasat, Dr. Arun Jaiswal Clinic , Redcross Road,Near Prashant Cinema, N/A Dr. Sailesh Kumar Mathur Clinic:173/B opp. Karyr Vysya Bank ATM,S R Nagar drpadmajagadish@gma il.com santanuguria@yahoo.c o.in drarifnathani@yahoo.co.in arunprati@gmail.com drsaileshmathur@gmail.com Dr. Satish Divine Hospital, #110,,6th Main Road,ITI Layout, ,Benson Town, skdoc77@rediffmail.co m Dr. Nayan Ranjan De DR. Dey's Chamber, Uluberia, Howrah,, Dr. Vaidyam Chakravarthi Durgabai Deshmukh Hospital & Research Center, Andhra Mahila Sabha,,Vidyanagar, Dr. Shakil Indian Clinic, Behind Forest Office, M.V Extension,,Hoskote, Dr. Javagal Suraj K R Hospital No.979,50ft Road, 25th Main Road, Bsk 1st Stg,Hanumantha Nagar Dr. Anjul Dayal Kids Kare Klinic opp. Oasis School,Shai kpet dr_chakravarthi@rediff mail.com shakeeljeelani@yahoo. com suraj_javagal@yahoo.c o.in dayalanjul@rediffmail.c page 3 / 9

4 Dr. Sanjay Mankar Mankar Children Hospital om Plot no: 4, Swaroop Society, Behind Santosh Hall,,Anand NJ and Nagar, Sinhgad om Road Dr. Vinod Shelar Medipoint Hospital S NO 49/2, Plot no-38, behind Balaji Car Wash Center,Shivraj Chowk, Chandan Nagar Dr. Pushpa Sampat Dr. Mohan Babu New Blue Print Poly Clinic 71, Ganesh Chandra Avenue, attitudevidu@yahoo.co.i n Pranav Diabetes Centre No53,Nanda Complex, Rammurthy Nagar main road, mohanbabudr@gmail.c om Dr. Santanu Ray Protyasha Clinic 41F, Block-C,New Alipur Dr. Prasanta Datta Puspa Medical Hall Mokterbari,,Badartala, Basirhat, Dr. Khaleel Ahmed Relief Hospital door no: /1, H. K. Plaza opp,ruman Hotel Tolichowki X-roads- Dr. Sonali Palkar Rucha Clinic, 1A,Saptashrungi Apartment,,1511 B, Sadashiv Peth Dr. Ramchandra Dhongade Dr. Saklecha Bikkamchand Sant Dyaneshwar Medical Research centre Santosh Hospital, 695/A,,Sadashiv peth, opp; Vijay talkies,laxmi road /1 Promenade Road, Near Goodwill,School, Frazer Town, Dr. Shantanu Ghosh Sarada Clinic Burikhali, Howrah, Santanu_ray@yahoo.c o.in khaleel78@yahoo.com sonalipalkar@rediffmail. com ramdhongade@hotmai 1.com santoshdiag@sify.com Dr.Adarsh E Shree Clinic No,450,BEML page 4 / 9

5 Details of Ethics Committee Dr Vijay Warad Dr. J Venkateswara Rao Dr. Sanjay Lalwani Shree Sai Multispeciality Hospital Layout,Basaveshwara Nagar Next to Gulabnagar last bus stop,dhanakawadi Shruthi Children's Clinic , Shanthi Apartments,,Gandhi nagar - N/A Siddhant Maternity Home Dr. Rehan Zafar Kazi Sofia clinic Flat No.2, Maul apartments,near Hotel Naaz, Opp. Konark puram, Kondhwa(Khurd)- adarshe@ymail.com vijaypwarad@gmail.co m dr_jvrao@yahoo.co.in 63 2b Kamala Heritage, ,1st Floor, Satara Road, sanjaylalwani2007@red iffmail.com rehankazi@yahoo.com Dr. N. Lakshmikanth Sri Child Health Centre #93,1I Stage, 1 Phase, Chandra Layout,Vijayan agar veenakanthu@gmail.co m Dr.Beeregowda Y.C Sri Chowdeshwari Child Health Care Srirama Temple Street,Near KSRTC Busstand Kolar Dr. Srikanth B. S. Suguna Hospital, 1A/87, Dr. Rajkumar Road,,4th N Block, Rajaji Nagar, Dr. Kanchan Kumar Das Dr. Sandeep Ganpat Kavade Suraj Pharmacy Vatsalya children?s hospital Mokterbari, Badartala,B asirhat PCMT Chowk, Gavhane Vasti,Bhosari Dr A S Deshpande Vatsalya Hospital, Opposite Cosmos Bank,,Panmala,Sinhagad Road beere999@yahoo.co.in drsrikanthbs@yahoo.co.in archanadusane@rediff mail.com anand3662@yahoo.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? 08. Central Approved 28/09/2010 Yes page 5 / 9

6 09. Central 1. Central 10. Central 11.Ethics Committee of 12.Ethics Committee of 13.Ethics Committee of 14.Ethics Committee of 15.Ethics Committee of 16.Ethics Committee of 17.Ethics Committee of 18.Ethics Committee of 19.Ethics Committee of 2. Central 20.Ethics Committee of 21.Independent Ethics 22.Independent Ethics 23.Independent Ethics 24.Independent Ethics 25.Independent Ethics 26.Independent Ethics 27.Independent Ethics Approved 28/09/2010 Yes Approved 21/10/2010 Yes Approved 21/10/2010 Yes Approved 21/10/2010 Yes Approved 09/09/2010 Yes Approved 21/10/2010 Yes page 6 / 9

7 28.Independent Ethics 29.Independent Ethics 3. Central 30.Independent Ethics 31. Central 32. Central 33. Central 34. Central 35. Central 36. Central 37. Central 38. Central 39. Central 4. Central 40. Central 41. Central 42. Central 5. Central 6. Central Approved 01/10/2010 Yes Approved 25/05/2010 Yes Approved 20/11/2010 Yes Approved 19/11/2010 Yes Approved 30/10/2010 Yes Approved 26/06/2010 Yes Approved 28/09/2010 Yes page 7 / 9

8 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria 7. Central Status Health Type Healthy Human Volunteers Date No Date Specified Condition Preventive protection against Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus Influenza type B diseases Type Details Intervention Reconstituted Pentavalent DTwPrHepB/HIB vaccine of BE Limited Comparator Agent None None Age From Age To Gender Details Day(s) Day(s) Both Inclusion Criteria 0.5ml/dose administered i.m. at weeks EPI Schedule 1) Healthy subjects of either sex in the age group of 6-8 weeks at the time of 1st vaccination. 2) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). 3) Written informed consent obtained prior to screening from subject?s parent or legally acceptable representative/guardian. 4) Healthy infants with weight? 3300 gms at the time of screening. 5) Ability of the subject?s parent or legally acceptable representative/guardian to understand and comply with the requirements of the subject diary. Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Open Label Exclusion Criteria 1) Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine. 2) Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period Or preceding the first dose of the study vaccine. 3) Known or suspected allergy to any of the vaccine components. 4) Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol. Primary Outcome Outcome Timepoints A) Proportion of solicited and unsolicited adverse events (AEs) B) Proportion of solicited and unsolicited local and systemic adverse events (AEs) C) Proportion of solicited and unsolicited adverse events (AEs) D) Proportion of subjects with serious and/or unexpected adverse events E) Rate of SAEs and medically attended AEs. A)during first 30 minutes of vaccine administration B) during 7-day (Day 0-6) post vaccination period, captured through subject diary.c) during the subsequent follow up period up to 28th day after each vaccination D) during the entire course of the study period E) until day 84 after the first vaccination. page 8 / 9

9 Powered by TCPDF ( REFCTRI/2010/ Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Clinically significant changes in vital signs (Pulse, axillary body temperature and Respiratory rate) Total Sample Size=640 Sample Size from India=640 04/10/2010 No Date Specified Years=0 Months=6 Days=0 Completed None From baseline (0 day) to Day 28, Day 56 and Day 84. This is a single arm phase-iv clinical trial to observe the safety of BE's reconstituted pentavalent DTwP-rHepB/HIB vaccine in 640 healthy 6-8 week old indian infants. The study vaccine is administered in 0.5ml/dose intramuscularly at week 3 dose schedule. The primary outcome is assessment of its safety and reactogenicity and secondary outcome is to observe any clinically significant changes in vital signs from baseline. page 9 / 9