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1 Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct :39:26 GMT) CTRI Number Last Modified On 06/04/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/11/ [Registered on: 04/11/2016] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group Trial A clinical study to evaluate adverse effects and immune responses of the 6-in-1 vaccine in children. Safety and Immunogenicity of a Hexavalent Vaccine (DTwP-HepB-Hib-IPV) in Toddlers and Infants. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) SH Version 1.0 Dated 22 April 2016) Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Somnath Mangarule Phone Fax Assistant General Manager- Clinical R and D Shantha Biotech Pvt Ltd (a Sanofi Company) 3rd and 4th Floor, Vasantha Chambers, , Fateh Maidan Road, Basheer Bagh, Hyderabad Telangana, Hyderabad ANDHRA PRADESH Somnath.Mangarule@Sanofi.com Details Contact Person (Public Query) Dr Somnath Mangarule Phone Fax Assistant General Manager- Clinical R and D Shantha Biotech Pvt Ltd (a Sanofi Company) 3rd and 4th Floor, Vasantha Chambers, , Fateh Maidan Road, Basheer Bagh, Hyderabad Telangana, East Godavari ANDHRA PRADESH Somnath.Mangarule@Sanofi.com page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Source of Monetary or Material Support > Shantha Biotechnics Pvt Ltd (A Sanofi Company) Type of Sponsor NIL List of Countries of Principal Investigator Dr Sonali Palkar Dr Monjori Mitra Primary Sponsor Details Shantha Biotechnics Pvt Ltd a Sanofi Company 3rd and 4th Floor, Vasantha Chambers, # , Fateh Maidan Road, Basheer Bagh, Hyderabad Telangana Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Bharati Vidyapeeth Deemed University Medical College and Hospital Pune Institute of Child Health, Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital Pune , Pune MAHARASHTRA Department of Pediatric Medicine Institute of Child Health, West Bengal , WEST BENGAL Dr M D Ravi JSS Hospital Mysore Department of Pediatrics JSS Hospital Mysore , Mysore KARNATAKA Dr A P Dubey Maulana Azad Medical College, New Delhi Department of Pediatrics Maulana Azad Medical College New Delhi , New Delhi DELHI palkarsh@gmail.com monjorimr@gmail.com ravimdped@yahoo.co.i n apdubey52@rediffmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee, ICH Approved 22/07/2016 No Committee Bharati Vidyapeeth Deemed University Pune Approved 23/08/2016 No Committee, JSS Hospital Mysore Committee, MAMC Approved 28/08/2016 No Approved 10/04/2017 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria New Delhi Status Date Approved/Obtained 26/10/2016 Health Type Healthy Human Volunteers Condition Vaccination for the prevention of tetanus, diphtheria, pertussis (whooping cough), poliomyelitis, hepatitis B (Hep B)and invasive Haemophilus influenzae type b (Hib) diseases. Type 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, and 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, and weeks of age) in infants. Route: Intramuscular Age From Age To Gender Details Day(s) Month(s) Both Inclusion Criteria For Toddlers 1. Children between 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 months of age. 4. Subject and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria Details 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. Exclusion Criteria 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 page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Sequentially numbered, sealed, opaque envelopes Open Label 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. 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 Target Sample Size Immunogenicity (Seroprotection/seroresponse rates and GMTs) Total Sample Size=195 Sample Size from =195 Phase of Trial Phase 1/ Phase 2 Baseline; 28 days after single dose in toddlers and 28 days post Dose-3 in infants page 4 / 5

5 Powered by TCPDF ( PDF of Trial 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 07/11/2016 No Date Specified Years=1 Months=6 Days=0 Not Applicable Completed 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, and 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. page 5 / 5