CTRI Number	CTRI/2016/11/007434 [Registered on: 04/11/2016] 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 Modification(s)	A clinical study to evaluate adverse effects and immune responses of the 6-in-1 vaccine in children.
Scientific Title of Study Modification(s)	Safety and Immunogenicity of a Hexavalent Vaccine (DTwP-HepB-Hib-IPV) in Toddlers and Infants.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  SH600001 Version 1.0 Dated 22 April 2016)  Protocol Number
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  3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. 500004 Telangana, India Hyderabad ANDHRA PRADESH 500004 India  Phone  04066301502   Fax  04023234133   Email  Somnath.Mangarule@Sanofi.com
Details Contact Person Public Query	Name  Dr Somnath Mangarule  Address  3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. 500004 Telangana, India East Godavari ANDHRA PRADESH 500004 India  Phone  04066301502   Fax  04023234133   Email  Somnath.Mangarule@Sanofi.com
Source of Monetary or Material Support	Shantha Biotechnics Pvt Ltd (A Sanofi Company)
Primary Sponsor	Name  Shantha Biotechnics Pvt Ltd a Sanofi Company  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 Palkar  Bharati Vidyapeeth Deemed University Medical College and Hospital Pune  Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital Pune-411043,India Pune   02024364308 palkarsh@gmail.com  Dr Monjori Mitra  Institute of Child Health, Kolkata  Department of Pediatric Medicine Institute of Child Health, Kolkata West Bengal-700017, India Kolkata   03322905686 monjorimr@gmail.com  Dr M D Ravi  JSS Hospital Mysore  Department of Pediatrics JSS Hospital Mysore-570 004, India Mysore   08212548363 ravimdped@yahoo.co.in  Dr A P Dubey  Maulana Azad Medical College, New Delhi  Department of Pediatrics Maulana Azad Medical College New Delhi-110002, India New Delhi   01123234845 apdubey52@rediffmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 4   Name of Committee  Approval Status  Ethics Committee, ICH Kolkata  Approved  Institutional Ethics Committee Bharati Vidyapeeth Deemed University Pune-411030  Approved  Institutional Ethics Committee, JSS Hospital Mysore-570004  Approved  Institutional Ethics Committee, MAMC New Delhi-110002  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied	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	Type  Name  Details  Intervention  Hexavalent (DTwP-HepB-Hib-IPV) vaccine  Dose:0.5ml, Single dose (at 15 to 18 months of age) in Toddlers and 3 dose series (at 6-8, 10-12 and 14-16 weeks of age) in infants. Route: Intramuscular  Comparator Agent  Shan5 and ShanIPV  Dose:0.5ml, Single dose of each vaccine (at 15 to 18 months of age) in Toddlers and 3 dose series of each vaccine (at 6-8, 10-12 and 14-16 weeks of age) in infants. Route: Intramuscular
Inclusion Criteria	Age From  42.00 Day(s) Age To  18.00 Month(s) Gender  Both  Details  For Toddlers 1. Children between 15-18 months of age whose Parents/ LAR has signed the written informed consent prior to the study inclusion. 2. Children with good general health as determined by the medical history, physical examination and clinical judgment of the investigator. 3. Children who have completed primary immunization series against Diphtheria, tetanus, pertussis, hepatitis b, Haemophilus influenza type b infections and poliomyelitis and have not received the booster dose scheduled at 15-18 months of age. 4. Subject and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures. For Infants 1. Infants between 6-8 weeks of age (42 to 56 days, both days inclusive) on the day of enrollment. 2. Born at full term of pregnancy (more than or equal to 37 weeks) with a birth weight more than or equal to 2.5 kg. 3. Infants who have received the birth dose of OPV, Hep B vaccine and BCG vaccine at least 4 weeks before the first trial vaccination. 4. Informed consent form signed by Parent or LAR. 5. Subject and Parent/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 in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. 2. 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. 3. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. 4. Blood or blood-derived products received in the 30 days or current or planned administration during the trial. 5. History of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, or Hep B, or poliomyelitis, infection(s) (confirmed either clinically, serologically or microbiologically). 6. Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity. 7. Known thrombocytopenia, as reported by the parent/ LAR. 8. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion. 9. Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness on the day of inclusion 10. Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study. 11. History of seizures or encephalopathy. Specific to Toddlers: 12. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within preceding 6 months or long-term systemic corticosteroids therapy 13. Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during trial participation. Specific to Infants 14. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroids therapy. 15. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. 16. Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination. 17. Previous vaccination (except the birth dose of OPV and Hep B vaccine) or planned receipt of any vaccine against the diphtheria, tetanus, pertussis, hepatitis B disease, Haemophilus influenzae type b infection or poliomyelitis, apart from trial vaccines in the 4 weeks following trial vaccination.
Method of Generating Random Sequence	Stratified block randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Safety after each and after any study vaccine dose, as applicable.  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 and 28 days post Dose-3 in infants
Target Sample Size	Total Sample Size="195" Sample Size from India="195"
Phase of Trial	Phase 1/ Phase 2
Date of First Enrollment (India) Modification(s)	07/11/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details
Brief Summary	This will be multi-center, randomized, active-controlled, open label, two-cohort, two-arm, three-staged, Phase I/II study of the hexavalent vaccine (DTwP-HepB-Hib-IPV) in toddlers (single dose) and infants (three dose regimen at 6-8, 10-12 and 14-16 weeks of age) using Shan5™+ ShanIPV™ as control vaccine. There will be stepwise enrolment of toddlers aged 15 to 18 months  followed by infants aged 6 to 8 weeks.The trial will involve 2 Cohorts: In Cohort I: 45 toddlers (15 to 18 months of age) and   Cohort II: 150 infants aged 6-8 weeks.The stepwise enrollment will be done in three stages:  In Stage I: Toddlers aged 15 to 18 months will be enrolled in Cohort I.     In Stage II: total 30 infants aged 6 to 8 weeks will be enrolled.   In Stage III:  120 infants aged 6 to 8 weeks will be enrolled in Cohort II.