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CTRI Number  CTRI/2012/08/002872 [Registered on: 09/08/2012] Trial Registered Prospectively
Last Modified On: 09/07/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Safety, Immunogenicity & lot consistency study of DPT-HepB-Hib pentavalent vaccine (Shan 5)as compared to a comparator pentavalent vaccine. 
Scientific Title of Study   Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SH501 Version 1.0 dated 14 APRIL 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mandeep Singh Dhingra MD 
Designation  Chief Clinical Officer, Chief PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad.

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301000  
Fax    
Email  drmandeep@shanthabiotech.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandeep Singh Dhingra MD 
Designation  Chief Clinical Officer, Chief PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad.


ANDHRA PRADESH
500004
India 
Phone  040-66301000  
Fax    
Email  drmandeep@shanthabiotech.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Singh Dhingra MD 
Designation  Chief Clinical Officer, Chief PV and CQA Officer 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad.


ANDHRA PRADESH
500004
India 
Phone  040-66301000  
Fax    
Email  drmandeep@shanthabiotech.co.in  
 
Source of Monetary or Material Support  
Shantha Biotechnics Limited 
 
Primary Sponsor  
Name  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad. 500004. AP, 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 = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Lalwani  Bharati Vidyapeeth deemed university medical college   Department of Pediatrics Bharati Hospital & Research Centre Katraj-Dhankawadi Road,Pune–411043,Maharashtra,India
Pune
MAHARASHTRA 		 020-40555555

sanjaylalwani2007@rediffmail.com 
Dr Jugesh Chhatwal  Christian medical College & Hospital-Ludhiana  Department of Pediatrics, Christian medical College & Hospital Brown Road Ludhiana-141008 Punjab, India
Ludhiana
PUNJAB 		 0161-5026999

jugeshchhatwal@rediffmail.com 
Dr Leni Grace Mathew  Christian Medical College (CMC) Hospital Vellore  Department of pediatrics,Christian medical College & Hospital, P.B. No.3,Ida Scudder Road, Vellore-632004, Tamil Nadu, India
Vellore
TAMIL NADU 		 0416-2283350

lenimathew@cmcvellore.ac.in 
Dr Ritabrata Kundu  Institute of Child Health  Department of pediatrics Institute of Child Health 11, Dr. Biresh Guha Street, Kolkata – 700 017,West Bengal, India
South Twentyfour Parganas
WEST BENGAL 		 033-22905686

rkundu22@gmail.com 
Dr M D Ravi  J.S.S Medical College  Department of pediatrics J.S.S Medical College Ramanuja Road Agrahara Mysore-570004,Karnataka,India
Mysore
KARNATAKA 		 0821-2548340

ravimdped@gmail.com 
Dr S M Dhaded  Jawaharlal Nehru Medical College KLES Dr. Prabhakar Kore Hospital and MRC   Department of pediatrics KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar Belgaum-590010 karnataka, India
Belgaum
KARNATAKA 		 0831-2471350

drdhadedsm@gmail.com 
Dr A P Dubey  Maulana Azad Medical College  Department of Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Gate New Delhi-110002
New Delhi
DELHI 		 011-23236031

apdubey52@rediffmail.com 
Dr Dulari J Gandhi  S.B.K.S Medical Institute & Research Center   Department of Pediatrics, S.B.K.S Medical Institute & Research Center At/Po. Piparia, Waghodia Road, Ta: Waghodia, Vadodara -390001,Gujarat
Vadodara
GUJARAT 		 02668-245262

djg_48@yahoo.co.in 
Dr Madhu Gupta  School of Public Health, Post Graduate Institute of Medical Education & Research (PGIMER)  Department of Community Medicine, School of Public Health, PGIMR, Chandigarh-160 012
Chandigarh
CHANDIGARH 		 0172-2744993

madhugupta21@gmail.com 
SDSharma  SMS Medical College & Attached Hospitals  Department of Pediatrics SMS Medical College & Attached Hospitals Sir Padampat M.C.H. Institute (J.K. Lone Hospital) J.L.N. Marg, Jaipur-302004, Rajasthan, India
Jaipur
RAJASTHAN 		 0141-2619827

sdsharmajp@yahoo.co.in 
Dr Sandeep Bavdekar  T N Medical College  Department of pediatrics T N Medical College and BYL Nair Hospital Dr A L Nair Road, Mumbai Central, Mumbai,400008,Maharashtra,India
Mumbai (Suburban)
MAHARASHTRA 		 022-23027138

sandeep.bavdekar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Bharati Vidyapeeth deemed university medical college, Pune, IEC  Approved 
Christian medical College & Hospital, Vellore, IEC  Approved 
Christian Medical College (CMC) Hospital, Ludhiana IEC  Approved 
Institute of Child Health, Kolkata IEC  Approved 
J.S.S Medical College, Mysore IEC  Approved 
Jawaharlal Nehru Medical College, Belgaum, KLE, IEC  Approved 
Maulana Azad Medical College, New Delhi IEC  Approved 
S.B.K.S Medical Institute & Research Center, Vadodra, IEC  Approved 
School of Public Health, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh IEC  Approved 
SMS Medical College & Attached Hospitals, Jaipur, IEC  Approved 
T N Medical College, Mumbai, IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention against Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus Influenzae type B diseases. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pentavac SDâ„¢  DTwP-HepB- Hib combined vaccine Dose:0.5 ml Frquency:3 dose series with 1 month gap between each dose (i.e at 6-8 week, 10-12 week and 14-16 week) and Single dose at 15-18 month Duration: Not Applicable Route:Intramuscular  
Intervention  Shan 5â„¢   DTwP-HepB-Hib pentavalent combination vaccine Dose:0.5 ml Frquency:3 dose series with 1 month gap between each dose (i.e at 6-8 week, 10-12 week and 14-16 week) and Single dose at 15-18 month Duration: Not Applicable Route:Intramuscular  
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  18.00 Month(s)
Gender  Both 
Details  1.Children between the age of 15-18 months whose parents/LAR is willing to give written informed consent prior to the study inclusion.
2.Children with good general health as determined by: Medical history, Physical examination and Clinical judgment of the investigator.
3.Children who have completed primary immunization series of diphtheria, tetanus, pertussis by virtue of previous immunization and have not received the booster dose scheduled at 15-18 months of age.
4.Children who require a dose of Hepatitis B as per National Immunization schedule/IAP recommendation because of one of the following reasons:
i)Has not received any dose of Hepatitis B or
ii)Have not completed primary vaccination against Hepatitis B
5.Children who require a dose of Haemophilus influenzae type b as per National Immunization schedule/IAP recommendation because of one of the following reasons:
i)Has not received any dose of Hib or
ii)Completed primary vaccination against Hib but not received the booster dose.
6.Judged to be able to attend all scheduled study visits and to comply with study procedures.
1. Infants between 6-8 weeks of age on the day of inclusion
2. Born at full term of pregnancy (≥37 weeks) with a birth weight ≥2.5 kg.
3. Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements
4. Able to attend all scheduled visits and to comply with all trial procedures
 
 
ExclusionCriteria 
Details  1.Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
2.Planned participation in another clinical trial during the present trial period
3.Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroids therapy(prednisone or equivalent at ≥ 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months)
4.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.(The list of vaccines components is included in the investigator’s brochure)
5.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator (Chronic illness may include, but is not limited to, haematological, hepatic, renal, cardiac or respiratory disease or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, or encephalopathy etc.)
6.Blood or blood-derived products received in the past (since birth) or current or planned administration during the trial (including immunoglobulins) that might interfere with the assessment of the immune response
7.Any vaccination before trial vaccination except OPV, HepB and BCG given at birth. (Cohort 2 only)
8.Any planned vaccination until one month after the last trial vaccination except;
(i)OPV during National Immunization Days (For both the Cohorts),
(ii)BCG if not given at birth (Cohort 2 only).
9.Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
10.Previous vaccination against pertussis, tetanus, diphtheria or Haemophilus influenzae type b infections (Cohort 2 only)
11.Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
12.Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating IM vaccination
13.History of seizures
14.Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment
 
 
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 
Seroprotection/ Seroresponse rates to five antigens for immunogenicity  one month after vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the vaccines  One month and six months after vaccination 
 
Target Sample Size   Total Sample Size="1100"
Sample Size from India="1100" 
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)   03/09/2012 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This clinical study will assess the immunogenicity and safety of Shantha’s DTPwHB-HIB (Shan 5 TM) combined vaccine against comparators vaccine given simultaneously to different groups as a single booster dose at 15-18 months and three-dose primary vaccination at 6-8,10-12, and 14-16 weeks of age subjects.

Study will evaluate equivalence of immunogenicity of three lots of Shan 5 and its non-inferiority to comparator vaccine in terms of seroprotection/ seroresponse rates to all antigens one month after a three-dose primary series (6-8, 10-12 and 14-16 weeks).

 
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