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1 Clinical Trial Details (PDF Generation Date :- Sat, 03 Nov :20:48 GMT) CTRI Number Last Modified On 12/12/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/01/ [Registered on: 19/01/2016] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group, Active Controlled Trial A Clinical trial to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD Vaccine in Healthy Infants A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD Vaccine when Administered in Three Doses to 6-8 weeks old Healthy Infants Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) HBI/Penta/III/2015/ Ver 01 Amend 01 Dated 31Aug2015 Designation Affiliation Protocol Number Details of Principal Investigator Dr S Sai Krishna Phone Fax Designation Affiliation Manager Medical Services (A division of n Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad Human Biologicals Institute (A division of n Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad Rangareddi s.saikrishna@indimmune.com Details Contact Person (Scientific Query) Dr S Sai Krishna Manager Medical Services (A division of n Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad Human Biologicals Institute (A division of n Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad Details Contact Person (Public Query) Phone Fax Designation Affiliation s.saikrishna@indimmune.com Details Contact Person (Public Query) Dr S Sai Krishna Manager Medical Services (A division of n Immunologicals page 1 / 6

2 Limited) Rakshapuram, Gachibowli Hyderabad Human Biologicals Institute (A division of n Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Type of Sponsor NIL List of Countries of Principal Investigator Dr T Ramesh Babu Dr Rajib Kumar Ray Dr M D Ravi Dr Sheila Bhave s.saikrishna@indimmune.com Source of Monetary or Material Support Primary Sponsor Details (A division of n Immunologicals Limited) Rakshapuram Gachibowli Hyderabad Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Gandhi Medical College and Hi-Tech Medical College and JSS Medical College & KEM Research Centre Pediatrics, Gandhi, Musheerabad, Secundrabad Hyderabad Paediatrics, Hi-Tech, Health Park, Pandara, Rasulgarh, Bhubaneswar, Odisha Khordha ORISSA Pediatrics, JSS Medical College &, Mysore, Karnataka Mysore KARNATAKA ramesh_ped@yahoo.co m drrajib2007@gmail.com ravimdped@gmail.com KEM Research Centre, Sardar Moodliar Road, Rasta kemhrc@vsnl.com Peth,Pune , Maharashtra Pune MAHARASHTRA Dr Rajat Kumar Das KPC Medical College page 2 / 6

3 Details of Ethics Committee Dr Mukta Mantan Dr B Krishnamurthy and Maulana Azad Medical College, New Delhi Mysore Medical College and Research Institute Paediatrics, KPC rkdforped@gmail.com, 1F, Raja Subodh Chandra Mullick Road, Jadavpur, Kolkata West Bengal Kolkata WEST BENGAL Pediatrics Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi New Delhi DELHI muktamantan@hotmail. com Dean and Director, Mysore Medical College and Research Institute, bkm876@gmail.com Mysore, Karnataka Mysore KARNATAKA Dr Madhu Gupta PGIMER, Chandigarh School of Public Health Community Medicine PGIMER Sector 12 Chandigarh Chandigarh CHANDIGARH Dr Ramchandra Dhongade Dr Padmasani Venkat Ramanan Sant Dnyaneshwar Medical Education Research Centre Sri Ramachandra Medical Centre Paediatrics, Sant Dnyaneshwar Medical Education Research Centre, 695/A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road, Pune , Maharashtra Pune MAHARASHTRA madhugupta21@gmail. com ramdhongade@hotmail. com Pediatrics, Sri Ramachandra Medical padmasani2001@yaho Centre, No.1, o.com Ramchandra Nagar, Porur, Chennai Chennai TAMIL NADU of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, Gandhi Medical College Committee, Hi-Tech Approved 16/02/2016 No Approved 11/02/2016 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Committee, JSS Committee, KEM Research Centre Committee, KPC Committee, Maulana Azad Medical College Committee, Mysore Research Institute Committee, Post Graduate Institute of Medical Education and Research Committee, Sant Dnyaneshwar Medical Education Research Centre Committee, Sri Ramachandra University Status Approved 14/12/2015 No Approved 10/12/2015 No Approved 17/12/2015 No Approved 28/03/2016 No Approved 14/01/2016 No Approved 21/01/2016 No Approved 04/02/2016 No Approved 29/03/2016 No Date Approved/Obtained 16/12/2015 Health Type Healthy Human Volunteers Condition Prevention against Diphtheria,Tetanus, Pertussis, Hepatitis B and Haemophillus Influenza Type B diseases Type Details Intervention HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine Three doses of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Human Biologicals Institute will be administered by intramuscular route in the anterolateral aspect of thigh region at 4 weeks interval. Comparator Agent Pentavac SD vaccine Three doses of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Serum Institute of will be administered by intramuscular route in the anterolateral aspect page 4 / 6

5 Inclusion Criteria Age From Age To Gender Details 1.50 Month(s) 2.00 Month(s) Both Inclusion Criteria of thigh region at 4 weeks interval. 1. Healthy infants (as determined by medical history, physical examination and clinical judgement of the investigator) of either gender of 6-8 weeks of age at the time of first dose of vaccination. 2. Born after a normal gestational period (36 42 weeks) with a birth weight? 2.5 kg. 3. Plans to remain in the study area for the duration of the trial. 4. Written informed consent for participation obtained prior to screening from subject s parent/legally acceptable representative. 5. Ability of the subject s parent/ legally acceptable representative to understand and comply with the requirements of the study. Exclusion Criteria Details Exclusion Criteria 1. Participation in another clinical trial in the 4 weeks preceding the trial vaccination. 2. Planned participation in another clinical trial during the present trial period. 3. History of immunization with any vaccine other than birth dose Polio, BCG and birth dose of Hepatitis B vaccines. 4. Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination except OPV. 5. Evidence of previous infection with Diphtheria, Tetanus, Pertussis, Hepatitis B and H. influenzae. 6. History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics. 7. Known personal or maternal history of HIV or hepatitis B seropositivity. 8. Infants having any intercurrent illness. 9. History of fever with temperature > 380C (>100.40F) in last 3 days. 10. Known or suspected primary or acquired disease of the immune system. 11. Known or suspected malignancy, receipt of allergy immunotherapy, or immunosuppressive therapy. 12. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction. 13. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 14. Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial period. 15. Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs. 16. Any history or evidence of thrombocytopenia or a bleeding disorder or receipt of anticoagulants. 17. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. Method of Generating Random Sequence Permuted block randomization, fixed page 5 / 6

6 Powered by TCPDF ( PDF of Trial Method of Concealment Blinding/Masking Sequentially numbered, sealed, opaque envelopes Participant Blinded Primary Outcome Outcome Timepoints Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine. Till 4 to 6 weeks post 3rd dose of vaccination Secondary Outcome Outcome Timepoints Till 4 to 6 weeks post 3rd dose of vaccination. Till 4 to 6 weeks post 3rd dose of vaccination Target Sample Size Phase of Trial Phase 3 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 Total Sample Size=405 Sample Size from =405 22/01/2016 No Date Specified Years=0 Months=8 Days=0 Not Applicable Completed A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD Vaccine when Administered in Three Doses to 6-8 Weeks Old Healthy Infants. The Primary objective is to determine the Immunogenicity i.e. the humoral immune response of individual components i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib after vaccination with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine. The Secondary objectives are: To determine that the Immunogenicity (seroconversion and seroprotection rate) of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine is not inferior to that of Pentavac SD vaccine group and to compare among the groups the proportion of the subjects experiencing local and/or systemic reactions during follow up period. Blood samples will be collected before the administration of first dose of vaccination and 4 to 6 weeks after the 3rd dose of the vaccination. The samples will be sent to a central lab for analysis. The study will be conducted in ten centres across. page 6 / 6

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