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CTRI Number  CTRI/2015/06/005837 [Registered on: 02/06/2015] Trial Registered Prospectively
Last Modified On: 21/10/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study on Pentavalent vaccine 
Scientific Title of Study   A Phase III Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) as compared to the licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-15/2015  DCGI 
SH505 Version 1.0 dated 10 Oct 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Badri Narayan Patnaik MD 
Designation  General Manager, Clinical R&D 
Affiliation  Shantha Biotechnics Private Limited 
Address  3rd and 4th Floor,Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. Telangana, India

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301300  
Fax  040-23234133  
Email  Patnaik.BadriNarayan@sanofi.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arijit Sil MD  
Designation  AGM Clinical R&D 
Affiliation  Shantha Biotechnics Private Limited 
Address  3rd and 4th Floor,Vasantha Chambers,5-10-173, Fateh Maidan Road,Basheer Bagh, Hyderabad.Telangana, India

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301515  
Fax  040-23234133  
Email  arijit.sil@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Dr. Arijit Sil, M.D.  
Designation  AGM Clinical R&D 
Affiliation  Shantha Biotechnics Private Limited 
Address  3rd and 4th Floor,Vasantha Chambers,5-10-173, Fateh Maidan Road,Basheer Bagh, Hyderabad.Telangana, India

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301515  
Fax  040-23234133  
Email  arijit.sil@sanofi.com  
 
Source of Monetary or Material Support  
Shantha Biotechnics Private Limited, Hyderabad 
 
Primary Sponsor  
Name  Shantha Biotechnics Private 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
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeev Zachariah K  Christian Medical College  Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu
Vellore
TAMIL NADU 		 0416-2283350

rajeev.k_zachariah@yahoo.in 
Dr Apurba Ghosh  Institute of Child Health  Department of Pediatric Medicine, Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata, West Bengal - 700 017.
Kolkata
WEST BENGAL 		 033-22905686

apurbaghosh@yahoo.com 
Dr E Venkata Rao  Institute of Medical Sciences and SUM Hospital  Department of Community Medicine, Institute of Medical science and SUM Hospital
Puri
ORISSA 		 0674-2382619

e.venkata.rao@gmail.com 
Dr D Rama Ganeshan  King George Hospital, Visakhapatnam  Department of Pediatrics, King George Hospital, Maharanipeta, Visakhapatnam, Andhra Pradesh -530002.
Visakhapatnam
ANDHRA PRADESH 		 0891-2727203

domathotirg@gmail.com 
Dr SM Dhaded  KLES JNMC and Dr Prabhakar Kore Hospital  Department of Pediatrics, J N Medical College, KLE Deemed University Belgaum, Karnataka - 590 010.
Belgaum
KARNATAKA 		 0831-2471350

drdhadedsm@gmail.com 
Dr Yashwant Gabhale  Lokmanya Tilak Municipal Medical College  Department of Pediatrics, L T M Medical College and L T M G Hospital, Sion
Mumbai
MAHARASHTRA 		 022-24076381

dryashg@rediffmail.com 
Dr Somashekar AR  M S Ramaiah Medical College and Hospital  Department of Pediatrics, M S Ramaiah Medical College and Hospital, New B E L Road, M S Ramaiah Nagar
Bangalore
KARNATAKA 		 080-23608888

s_arshekar2002@yahoo.com 
Dr Harish B R  Mandya Institute of Medical Sciences  Department of Community Medicine, Mandya Institute of Medical Sciences, Bangalore-Mysore Road, Mandya, Karnataka-571401
Mysore
KARNATAKA 		 08232-220339

harishmims@gmail.com 
Dr Prashanth S  Mysore Medical College and Research Institute and Cheluvamba Hospital  Department of Pediatrics, Mysore Medical College and Research Institute and Cheluvamba Hospital, Irwin Road, Mysore, Karnataka-570021
Mysore
KARNATAKA 		 0821-2520512

drsp2013@rediffmail.com 
Dr Sharad Agarkhedkar  Padmasree Dr.D.Y.Patil Medical College, Hospital and Research Center  Dept of Pediatrics, Padmashree Dr D Y Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra -411018.
Pune
MAHARASHTRA 		 020-27420605

ashalaka@gmail.com 
Dr Madhu Gupta  Post Graduate Institute of Medical Education and Research (PGIMER)  Department of Community Medicine, School of Public Health, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh-160 012.
Chandigarh
CHANDIGARH 		 0172-2690727

madhugupta21@gmail.com 
Dr Adarsh E  Raja Rajeswari Medical College and Hospital  Department of Pediatrics, Raja Rajeswari Medical College and Hospital
Bangalore Rural
KARNATAKA 		 080-28437512

dradarsh.d2l@gmail.com 
Dr Vandana Kumavat  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  Department of Pediatrics, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Kalwa
Thane
MAHARASHTRA 		 022-5347784

drvandanak@hotmail.com 
Dr Durga Madhab Satapathy  S C B Medical College, Cuttack, Odisha  Department of Social and Preventive Medicine, S C B Medical College
Cuttack
ORISSA 		 0671-2111111

drdurgams@rediffmail.com 
Dr Dulari J Gandhi  Smt Bikhiben Kantibai Shah Medical College  Department of Pediatrics, Dhiraj General Hospital, SBKS Medical College and Research Center, Piparia, Waghodia
Vadodara
GUJARAT 		 02668-245262

djg_48@yahoo.co.in 
Dr Satyajit Mohapatra  Sri Ramachandra Medical College and Research Institute  Department of Pharmacology, SRM Medical College Hospital & Research Centre, SRM University, Potheri
Chennai
TAMIL NADU 		 044-27455708

satyajitmp@gmail.com 
Dr Sunil Gomber  University college of Medical Sciences(UCMS) and Guru Teg Bahadur Hospital  Department of Pediatrics UCMS and GTB Hospital Dilshad Garden
New Delhi
DELHI 		 011-22582106

sunilgomber@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
Ethics Committee, Dr.D.Y.Patil MC, Pune  Approved 
Ethics Committee, ICH, Kolkata  Approved 
Ethics Committee, JNMC, Belgaum  Approved 
Ethics Committee, MMC, Mysore  Approved 
Ethics Committee, MSR, Bangalore  Approved 
Institutional Clinical Ethics Committee, RGMC, Thane  Not Applicable 
Institutional Ethics Committee, IMS, Bhubaneswar  Approved 
Institutional Ethics Committee, KGH, Visakhapatnam  Approved 
Institutional Ethics Committee, MIMS, Mandya  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee, RRMC Bangalore  Approved 
Institutional Ethics Committee, SBKS, Vadodara  Approved 
Institutional Ethics Committee, SCB, Cuttack  Not Applicable 
Institutional Ethics Committee, SRMC, Chennai  Approved 
Institutional Ethics Committee-HR, LTMMC, Mumbai  Approved 
Institutional Ethics Committee-HR, UCMS, Delhi  Not Applicable 
Institutional Review Board, CMC, Vellore  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Infants of either sex between 42-56 days 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with imported pertussis)  0.5mL dose administered intramuscularly to healthy Indian infants at the age of 6-8, 10-12 and 14-16 weeks of age 
Intervention  Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis)  0.5mL dose administered intramuscularly to healthy Indian infants at the age of 6-8, 10-12 and 14-16 weeks of age 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  1.Healthy Infants of either sex between 42-56 days (6 to 8 weeks) of age on the day of enrollment
2.Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
3.Informed consent form signed by parent or legally acceptable representative (LAR) as per local requirements.
4.Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
 
 
ExclusionCriteria 
Details  An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
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.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV if not given at birth and during National Immunization Day (NID).
4.Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
5.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
6.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth).
7.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections (confirmed either clinically, serologically or microbiologically).
8.Known personal or maternal history of HIV or hepatitis B seropositivity.
9.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.
10.Known thrombocytopenia, as reported by the parent/ legally acceptable representative.
11.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
12.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. (Chronic illness may include, but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy etc.).
13.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 100.4 °F or ≥38 °C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided).
14.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
15.Subject with definite seizure disorder and getting anticonvulsant therapy. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the non-inferiority of the Pentavalent vaccine (DTwP-HepB-Hib), Shan5 (with Shantha pertussis) to licensed vaccine Shan5 (with imported pertussis) in terms of eroprotection/seroresponse rates to all antigens  one month after a three-dose primary series. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and Immunogenicity  One month after dosing 
 
Target Sample Size   Total Sample Size="1040"
Sample Size from India="1040" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/06/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Will be published once the trail completes. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This is a Phase III, Multi-center, Randomized, Two-Arm, Single Blind study planned to be conducted in 1040 infants across in India. The eligible infants will be randomized in 1:1 ratio to receive either Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) or the licensed vaccine Shan5 (with imported pertussis). The randomized infants will receive 03 doses of respective vaccine at 6-8, 10-12 and 14-16 weeks of age as per the EPI schedule. The vaccinated infants will be observed for 30 minutes post-vaccination to observe for any immediate adverse events and followed up for safety and immunogenicity for 28 days following each dose of the vaccine. Approximately 3.5 to 5 mL of two (2) blood samples, one just before the first dose of vaccination and another one 1 month after the third dose of vaccination will be collected from all the enrolled subjects. Serum samples prepared from these blood samples will be analyzed for Seroprotection of Diphtheria, Tetanus, Hepatitis B and Haemophilus influenzae type b antigens as well as Seroresponse for Pertussis antigen.
 
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