CTRI Number	CTRI/2018/04/013375 [Registered on: 19/04/2018] Trial Registered Prospectively
Last Modified On:	30/06/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Vaccine
Study Design	Randomized, Parallel Group Trial
Public Title of Study	A clinical study to evaluate adverse events and immune responses of the 6-in-one SHAN6™ vaccine in children
Scientific Title of Study Modification(s)	Safety and Immunogenicity of booster dose of a Hexavalent Vaccine SHAN6™ (DTwP-HepB-Hib-IPV) with or without co-administration of MMR vaccine in Toddlers
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name    Address    Phone     Fax     Email
Details Contact Person Scientific Query	Name  Dr Somnath Mangarule  Address  Shantha Biotechnics Pvt Limited, 3rd and 4th Floor, Vasantha Chambers Fateh Maidan Road, Basheer Bagh, Hyderabad. Telanagana Hyderabad ANDHRA PRADESH 500004 India  Phone  914066301502   Fax     Email  somnath.mangarule@sanofi.com
Details Contact Person Public Query	Name  Dr Somnath Mangarule  Address  Shantha Biotechnics Pvt Limited, 3rd and 4th Floor, Vasantha Chambers Fateh Maidan Road, Basheer Bagh, Hyderabad. Telanagana Hyderabad ANDHRA PRADESH 500004 India  Phone  914066301502   Fax     Email  somnath.mangarule@sanofi.com
Source of Monetary or Material Support Modification(s)	Shantha Biotechnics Pvt Ltd 3 and 4 floor Vasantha Chambers Fateh Maidan Road Basger bagh Hyderabad 500004
Primary Sponsor	Name  Shantha Biotechnics Pvt Limited  Address  3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. 500004. Telangana, India   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 4   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Sonali Hemant Palkar   Bharati Vidyapeeth Deemed University Medical College and Hospital   Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital Pune-411043,India Pune   020-024364308 palkarsh@gmail.com  Dr Monjori MITRA  Institute of Child Health  Department of Pediatric Medicine Institute of Child Health, Kolkata West Bengal-700017, India Kolkata   033-22905686 monjorimr@gmail.com  Dr M D Ravi   JSS Hospital   Department of Pediatrics JSS Hospital Mysore-570 004, India Mysore   0821-2548363 ravimdped@yahoo.co.in  Dr Raghvendra SINGH   Maulana Azad Medical College   Department of Pediatrics Maulana Azad Medical College New Delhi 110002 India New Delhi   01123234845 drraghvendrasingh@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 4   Name of Committee  Approval Status  Institutional Ethics Committee Bharati Vidyapeeth Deemed University Pune-411030  Approved  Institutional Ethics Committee, Institute of Child Health Kolkata-700017  Approved  Institutional Ethics Committee, JSS Hospital Mysore-570004  Approved  Institutional Ethics Committee, MAMC New Delhi-110002  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Vaccination for the prevention of tetanus, diphtheria, pertussis (whooping cough), poliomyelitis, hepatitis B (Hep B)and invasive Haemophilus influenzae type b (Hib) diseases.
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Not applicable  Not applicable  Intervention  SHAN6™ (DTwP-HepB-Hib-IPV)   Single dose, 0.5mL dose administered by Intramuscular route,
Inclusion Criteria	Age From  12.00 Month(s) Age To  24.00 Month(s) Gender  Both  Details  1. Subjects, who have received 3 doses of the same study vaccine (either SHAN6™ or SHAN 5®+SHANIPV™) as part of previous study 2. Children between 12-24 months of age whose parents/ LAR, has signed the written informed consent prior to study inclusion 3. Children with good general health as determined by: medical history, physical examination and clinical judgment of the investigator. 4. Children who are yet to receive the booster dose in second year of life. 5. Subjects and Parents/LAR are able to attend all scheduled visits and to comply with all study procedures.
ExclusionCriteria	Details  1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period 2. Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2( Except OPV during national immunization days) 3. Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. 4. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. 5. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, within preceding 6 months 6. Blood or blood-derived products received in the 30 days or planned administration during the trial. 7. History of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, or Hep B, or poliomyelitis 8. Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity. 9. Known thrombocytopenia, 10. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, 11. Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination 12. Identified as a natural or adopted child of the Investigator,relatives or employee with direct involvement in the proposed study. 13. Known precautions to further vaccination with pertussis vaccine
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Safety   Immidiate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination.
Secondary Outcome	Outcome  TimePoints  Immunogenicity (Seroprotection/seroresponse rates and GMTs)  Baseline; 28 days after single dose in toddlers
Target Sample Size	Total Sample Size="150" Sample Size from India="150"
Phase of Trial	Phase 2
Date of First Enrollment (India)	13/05/2018
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	None yet
Brief Summary	The infants enrolled in SH600001 study, will be due for booster dose in their second year of life.In this study a single booster dose Shan6 will be administered, with or without co-administration of MMR vaccine, to these infants. The participants will be followed for safety and immunogenicity 28 days after the administration of study vaccine. This is a multi-center, open label study.