FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024843 [Registered on: 24/04/2020] Trial Registered Prospectively
Last Modified On: 28/05/2021
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 immune responses and adverse events of the 6-in-one SHAN6® vaccine in children 
Scientific Title of Study   Immunogenicity and Safety of SHAN6® vaccine when administered as booster in healthy toddlers in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SH600004 Version 1.0 dated 08 November 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Somnath Mangarule 
Designation  Assistant General Manager 
Affiliation  Sanofi Healthcare India Pvt ltd 
Address  Sanofi Healthcare India Pvt ltd (formerly known as Shantha Biotechnics Pvt Limited )
4th Floor, Vasantha Chambers Fateh Maidan Road, Basheer Bagh,
Hyderabad
TELANGANA
500004
India 
Phone  04066301502  
Fax    
Email  somnath.mangarule@sanofi.com  
 
Details of Contact Person
Public Query
 
Name  Dr Somnath Mangarule 
Designation  Assistant General Manager 
Affiliation  Sanofi Healthcare India Pvt ltd 
Address  Sanofi Healthcare India Pvt ltd (formerly known as Shantha Biotechnics Pvt Limited )
4th Floor, Vasantha Chambers Fateh Maidan Road, Basheer Bagh,
Hyderabad
TELANGANA
500004
India 
Phone  04066301502  
Fax    
Email  somnath.mangarule@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi Healthcare India Pvt ltd formerly known as Shantha Biotechnics Pvt Limited  
 
Primary Sponsor  
Name  Sanofi Healthcare India Pvt Ltd formerly known as Shantha Biotechnics Pvt Ltd 
Address  4th Floor,Vasantha Chambers, 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
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonali Palkar  Bharati Vidyapeeth Deemed University Medical College and Hospital   Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital Pune-411043,India
Pune
MAHARASHTRA 
02024364308

palkarsh@gmail.com 
Dr Monjori Mitra  Institute of Child Health  Department of Pediatric Medicine Institute of Child Health Kolkata
Kolkata
WEST BENGAL 
033-22905686
033-22905686
monjorimr@gmail.com 
Dr M D Ravi   JSS Hospital   Department of Pediatrics JSS Hospital Mysore
Mysore
KARNATAKA 
0821-2548363

ravimdped@yahoo.co.in 
Dr Ranjitha Shetty  Kasturba Medical College  Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
9110401395
0820-2922275
ranjitha.shetty@manipal.edu 
Dr Anand Kawade  King Edward Memorial Hospital Research Centre Vadu Rural Health Program  Department of Paediatrics King Edward Memorial Hospital Research Centre Vadu Rural Health Program Village-vadu (Budruk), Tal-Shirur, Pune-412216
Pune
MAHARASHTRA 
02026065603

askawade@yahoo.com 
Dr Raghvendra Sngh  Maulana Azad Medical College   Department of Pediatrics Maulana Azad Medical College New Delhi
New Delhi
DELHI 
01123234845
01123234545
drraghvendrasingh@gmail.com 
Dr Prashanth S  Mysore Medical College   Department of Pediatrics Mysore Medical College Research Institute and Cheluvamba Hospital Mysore
Mysore
KARNATAKA 
08105028742
08212520803
drprashanths10@gmail.com 
Dr Virendra Nath Tripathi  Prakhar Hospital Pvt Ltd   Department of Pediatrics Prakhar Hospital Pvt Ltd, Arya Nagar, Kanpur,UP 208002
Kanpur Nagar
UTTAR PRADESH 
9415050777

drvntripathi@gmail.com 
Dr Nithya Gogtay  Seth GS Medical College and King Edward Memorial Hospital  Department of Clinical Pharmacology Seth GS Medical College & King Edward Memorial Hospital, Mumbai 400012
Mumbai
MAHARASHTRA 
9820495836
02224112871
njgogtay@hotmail.com 
Dr Padmavathi IV  Victoria Government Hospital  Department of Paediatrics, Victoria Government Hospital Chengala Rao Peta, Purna market, Visakhapatnam-530001 Andhra Pradesh Visakhapatnam
Visakhapatnam
ANDHRA PRADESH 
9666140568

padmavathi.vgh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee of the Prakhar Hospital  Approved 
Ethics Committee, KEM hospital Research centre Pune  Approved 
Institutional Ethic Committee, King George Hospital, Visakhapatnam   Approved 
Institutional Ethics Committee, Mysore Medical College & Research Institute and Associated Hospitals Mysore  Approved 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Medical College Pune  Approved 
Institutional Ethics Committee, Institute of Child Health Kolkata  Approved 
Institutional Ethics Committee, JSS Medical college & Hospital, Mysore  Approved 
Institutional Ethics Committee, Maulana Azad Medical College,New Delhi  Approved 
Institutional Ethics Committee-I, Seth GS Medical College and KEM hospital Mumbai  Approved 
MAHE Ethics Committee, Mezzanine Floor KMC old Library building, Madhva Nagar Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
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 
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 and provided the Pre and post dose blood sample, by virtue of their participation in the Phase III study (Study code: SH600003)
2) Subjects (now toddler) between 12-24 months of age whose parents/ Legally Acceptable Representative (LAR), has signed the written informed consent.
3) Toddlers with good general health.
4) Toddlers who have not received any vaccine containing Diphtheria(D), Tetanus(T), whole cell Pertussis(wP), acellular pertussis (aP), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib), Inactivated polio vaccine (IPV) vaccine in second year of life.
5) Toddlers who have received their first dose of Measles/ Measles containing vaccines at least 4 weeks before the enrollment in the study
6) 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
2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during the trial participation period.
3) Receipt of 2 doses of Measles/ Measles containing vaccines before enrollment in the study.
4) Known systemic hypersensitivity to any of the vaccine components
5) Chronic illness at a stage that could interfere with trial conduct
6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, within preceding 6 months or long-term systemic corticosteroids therapy within the past 3 months.
7) Blood or blood-derived products received in the 30 days
8) Documented history of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, Hepatitis B, poliomyelitis, measles, mumps or rubella infection(s)
9) Known personal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity.
10) Known thrombocytopenia,
11) Bleeding disorder or receipt of anticoagulants in the 3
12) Moderate or severe acute illness/infection or febrile illness on the day of inclusion
13) Identified as a natural or adopted child of the Investigator, relatives or employee.
14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
16) Known precautions to further vaccination with pertussis vaccine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Immunogenicity (Seroprotection rates/Vaccine response rates/GMCs)

Safety: Immediate systemic adverse events, Solicited reactions, unsolicited adverse events, SAEs and AESI 
Baseline and 28 days after booster dose.

Safety: Immediate events within 30 mins, solicited reactions within 7 days, unsolicited adverse events, SAES and AESI till Day 28  
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity (immune responses for MMR)   28 days after administration of MMR vaccine. 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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 3 
Date of First Enrollment (India)   26/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Sanofi Healthcare India Pvt Ltd (formerly Known as Shantha Biotechnics Pvt Ltd)  has developed Shan6, a hexavalent vaccine, which was safe and immunogenic in Phase I and Phase II studies. 

Purpose: Current study is designed to demonstrate immunogenicity and safety of Shan6 when administered as booster dose, with or without coadministration of MMR vaccine, in toddlers, who are already primed with 3 doses of either Shan6 or SHAN5+ SHANIPV vaccines.

Design: This will be a multi-center, open label, randomized, two-arm, phase III study to be conducted in a maximum of 1200 toddlers, who were participants of the SH600003 clinical trial. Group A will receive SHAN6+MMR on Day 0,  and Group B will receive SHAN6 on Day 0 and MMR on Day 28.

 
Close