PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 10:29:20 GMT)
CTRI Number CTRI/2018/06/014617 [Registered on: 26/06/2018] - Trial Registered Prospectively Last Modified On 26/07/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Safety and immunogenicity assessment of Tdap vaccine in healthy adults, adolescent and children. Scientific Title of A Phase II/III, Multicenter, Randomized, Open Label, Active Controlled, Clinical Study to Assess the Study Immunogenicity and Safety of Tetanus Toxoid, Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine Manufactured by Serum Institute of India Pvt. Ltd (SIIPL) in Comparison with Boostrix® Vaccine of GSK in Healthy Adults, Adolescents and Children in India. Secondary IDs if Any Secondary ID Identifier SII-Tdap/IN-02 Version: 3.0 Date: 24-Jun-2020 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Hitt Sharma Trial Coordinator (multi-center study) Designation Additional Medical Director Affiliation Serum Institute of India Pvt. Ltd. Address Clinical Research and Pharmacovigilance Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India Phone 020-26602451 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Hitt Sharma Query) Designation Additional Medical Director Affiliation Serum Institute of India Pvt. Ltd. Address Clinical Research and Pharmacovigilance Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India Phone 020-26602451 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Hitt Sharma Designation Additional Medical Director Affiliation Serum Institute of India Pvt. Ltd. Address Clinical research and Pharmacovigilance, Serum Institute of India Pvt. Ltd. 212/ 2, Hadapsar, Pune MAHARASHTRA 411028 India Pune MAHARASHTRA 411028 India
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Phone 020-26602451 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Serum Institute of India Pvt. Ltd. 212/2, Hadapsar, Pune-411028, Maharashtra, India Primary Sponsor Primary Sponsor Details Name Serum Institute of India Pvt Ltd Address 212/2, Hadapsar, Pune Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Jitendra Oswal Bharti Vidyapeeth Department of 020-24364308 Deemed University pediatrics, Pune-Satara Medical college & Road, Katraj researchpedpune@gm Hospital Dhankawdi, ail.com Pune-411043 Pune MAHARASHTRA Dr Varughese PV Christian Medical Dept of Peadiatrics, 0161-2115644 College Christian Medical College, Brown Road, drpvvarughese@yahoo. Ludhiana-141008, com Punjab, India Ludhiana PUNJAB Dr A V Rao Gleneagles Global Gleneagles Global 040-30644444 Hospitals Hospitals, 6-1-1070/1 to 4 Lakdikapul, [email protected] Hyderabad -500004 n Hyderabad ANDHRA PRADESH Dr Apurba Ghosh Institute of Child Health Institute of Child Health, 033-22905686 11,Dr. Biresh Guha Street, Kolkata,700017 [email protected] Kolkata om WEST BENGAL Dr M D Ravi JSS Hospital Dept of Peadiatrics, 0821-2335555 Mahatma Gandhi Road, Mysore-570004 [email protected] Mysore KARNATAKA Dr S Balasubramaniam Kanchi Kamakoti Childs 12A, Nageswara Road, 044-42001800 Trust Hospital Nungambakkam, Chennai-600034 [email protected] Chennai TAMIL NADU Dr Anand Kawade KEM Hospital Research KEM Hospital Pune, 9850559983 centre Ankit Shirdi Sai Baba Rural [email protected] Hospital,A/P-Vadu
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Budruk, Taluka- Shirur, District Pune- 412216 Pune MAHARASHTRA Dr N S Mahantshetti KLEs Dr Prabhakar KLEs Dr Prabhakar 0831-2471350 Kore Hospital and Kore Hospital and Medical research MRC, Nehru Nagar, Bel [email protected] Centre gavi-590010,Karnataka, m India Belgaum KARNATAKA Dr Somashekar A R M S Ramaiah Medical Department of 080-23601923 College and Hospital Pediatrics,Romm No-104, M. S. Rmaiah s_arshekar2002@yaho Nagar,MSRIT Post , o.com Bangalore -560054, Karnataka, India. Bangalore KARNATAKA Dr Saji James Sri Ramchandra Dept of Peadiatrics, No. 9841223038 Hospital 1 Ramchandranagar, Porur, Chennai-600116 [email protected] Chennai m TAMIL NADU Dr Renuka Munshi Topiwala National Dr. AL Nair Road, 022-23027204 Medical College and Mumbai Central, BYL Nair Ch Hospital Mumbai – 400008 renuka.munshi@gmail. Mumbai com MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee, M. Approved 17/07/2018 No S. Ramaiah Medical College and Hospital, Bangalore Institutional Ethics Approved 18/07/2018 No Committee, Bharati Vidyapeeth Deemed University, Pune Institutional Ethics Approved 28/08/2018 No Committee, Christian Medical College, Ludhiana Institutional Ethics Approved 06/09/2018 No Committee, Gleneagles Global Hospitals, Hyderabad Institutional Ethics Approved 08/06/2018 No Committee, JSS Medical College and Hospital, Mysore Institutional Ethics Approved 31/07/2018 No Committee, King Edward Memorial Hospital Research Centre Pune Institutional Ethics Approved 15/10/2018 No Committee, Sri
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Ramchandra Medical College and Research Institute, Chennai Institutional Ethics Approved 04/02/2020 No Committee, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai Institutional Ethics Approved 08/08/2018 No Committee,, Institute of Child Health, Kolkata Institutional Eyhics Approved 06/07/2018 No Committee, KLE University, JN Medical college, Nehru Nagar, Belgavi Institutional Review Approved 22/10/2018 No Board, Ethics Committee of Kanchi Kamakoti Childs Trust Hospital and The Child Trust Medical Research Foundation, Chennai Regulatory Clearance Status Date Status from DCGI Approved/Obtained 27/07/2020 Health Condition / Health Type Condition Problems Studied Patients Encounter for immunization Intervention / Type Name Details Comparator Agent Intervention Tdap vaccine by SIIPL 0.5 ml intramuscular, single dose Comparator Agent BOOSTRIX® vaccine of GSK 0.5 ml intramuscular, single dose Inclusion Criteria Inclusion Criteria Age From 4.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1 Healthy male or female subjects aged 4 years to 65 years on the day of enrollment
2 Healthy subjects as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator
3 Sexually active participants to be using an effective method of contraception 30 days prior to the enrollment and throughout the study period
4 Subjects/ parent willing to provide assent or written informed consent
5 Subjects/ parent willingness and ability to comply with the requirements of the protocol
Exclusion Criteria Exclusion Criteria Details 1.History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 yrs. 2.History of Tetanus, diphtheria or pertussis infection 3.History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation. 4.History of a serious reaction to any prior vaccination or known
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hypersensitivity to any component of the study vaccines. 5.History of anaphylactic shock. 6.History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability or blood dyscrasias. 7.History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with a vaccine containing a pertussis component. 8.History of neurological complications following an earlier vaccination against diphtheria and/or tetanus. 9.Acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination. 10.Receipt of any oral or injectable antibiotics 5 days before enrollment. 11.History of any cancer, HIV infection, organ transplant or any other immune system disorder. 12.Chronic administration of immunosuppressant or other immune modifying drugs during the period starting six months prior to the study vaccine dose. 13.History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination. 14.Females who are pregnant, breastfeeding or planning to become pregnant. 15. 15.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints 1)Percentage of subjects achieving the booster One month after the vaccination responses to diptheria toxoid 30 days after vaccination with Tdap and Boostrix 2)Percentage of subjects achieving the booster responses to tetanus toxoid 30 days after vaccination with Tdap and Boostrix 3)Percentage of subjects achieving booster response for PT, FHA and PRN 30 days after vaccination with Tdap and Boostrix 4)Anti-PT, anti-FHA and antiPRN antibody GMCs 30 days after vaccination with Tdap and Boostrix
Secondary Outcome Outcome Timepoints 1)Percentage of subjects with seroprotection One month after the vaccination against Diphteria and Tetanus 30 days after vaccination 2)Percentage of seropositive subjects against Pertussis antigens 30 days after vaccination 3)Antibody geometric mean concentrations for anti-diphtheria, anti-tetanus 30 days after vaccination in both the groups 4)Frequency of adverse event that occurred
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during the 30 days follow-up period after vaccination. Target Sample Size Total Sample Size=1500 Sample Size from India=1500 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2/ Phase 3 Date of First 02/07/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Closed to Recruitment of Participants Trial (India) Publication Details None yet Brief Summary This is a multicenter, randomized, active controlled, open label Phase II/ III clinical study to assess the immunogenicity and safety of Tdap vaccine manufactured by SIIPL in comparison with Boostrix® vaccine of GSK. Healthy adults, adolescents and children will be enrolled in the study. Eligible participants will be randomized in a 1:1 ratio. A single 0.5 mL dose of the vaccine (Tdap vaccine by SIIPL or Boostrix®) will be administered by intramuscular injection. The objective of the trial is to demonstrate immunogenic non-inferiority of Tdap vaccine compared to Boostrix® and to assess the reactogenicity and safety of single dose of Tdap vaccine in comparison with Boostrix®.
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