FULL DETAILS (Read-only)

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
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 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  

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
Phone  914066301502  
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
Phone  914066301502  
Email  somnath.mangarule@sanofi.com  
Source of Monetary or Material Support
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 
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

Dr Monjori MITRA  Institute of Child Health  Department of Pediatric Medicine Institute of Child Health, Kolkata West Bengal-700017, India

Dr M D Ravi   JSS Hospital   Department of Pediatrics JSS Hospital Mysore-570 004, India

Dr Raghvendra SINGH   Maulana Azad Medical College   Department of Pediatrics Maulana Azad Medical College New Delhi 110002 India
New Delhi

Details of Ethics Committee
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  
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 
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.
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"
Recruitment Status of Trial (Global)
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
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.