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CTRI Number  CTRI/2015/05/005768 [Registered on: 13/05/2015] Trial Registered Prospectively
Last Modified On: 14/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to compare immune response and safety of DPT vaccine of Cadila Healthcare Ltd. with DPT vaccine of Serum Institute of India Ltd. in healthy children 
Scientific Title of Study   A prospective, randomized, two-arm, single-blind, parallel, active-controlled, multicentre, non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety of Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Limited compared to Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) of M/s Serum Institute of India Limited in healthy infants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
14-06; Version No. 00; Dated 11/07/2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Mittal 
Designation  Medical Advisor & Head - Regulatory Af 
Affiliation  Cadila Healthcare Ltd. 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  079-26868926  
Fax  079-26868910  
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravindra Mittal 
Designation  Medical Advisor & Head - Regulatory Af 
Affiliation  Cadila Healthcare Ltd. 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  079-26868926  
Fax  079-26868910  
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pavankumar Daultani 
Designation  Manager – New Product Development 
Affiliation  Cadila Healthcare Ltd. 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  079-26868937  
Fax  079-26868910  
Email  pavankumar.daultani@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Ltd. Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015, Gujarat 
 
Primary Sponsor  
Name  Cadila Healthcare Ltd 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015 
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 = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D Ramaganeshan  Andhra Medical College & King George Hospital, Visakhapatnam  Pediatric ward, Unit-III, 1st floor, Department of Pediatrics, Andhra Medical College & King George Hospital, Maharanipeta
Visakhapatnam
ANDHRA PRADESH 
09848337511

domathotirg@gmail.com 
Dr T Ramesh Babu  Gandhi Hospital, Secunderabad  Study room, 1st floor, main building, Department of Pediatrics, Gandhi Hospital, Musheerabad, Secunderabad
Hyderabad
ANDHRA PRADESH 
09247119597

ramesh_ped@yahoo.com 
Dr Himanshu Arvind Joshi  GMERS Medical College & Civil Hospital, Ahmedabad  Room No. 34, Transit OPD, 1st floor, Department of Pediatrics, Civil Hospital, Sola, S.G. Highway, Near New Gujarat High Court
Ahmadabad
GUJARAT 
09825014937

drhimanshujoshi60@gmail.com 
Dr Rajib Kumar Ray  Hi-Tech Medical College and Hospital, Bhubaneswar  Department of Pediatrics, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar
Khordha
ORISSA 
09338089618

drrajib2007@gmail.com 
Dr Jaydeep Choudhury  Institute of Child Health, Kolkata  Room No. 113, Ground floor, Institute of Child Health, 11, Dr. Biresh Guha Street
Kolkata
WEST BENGAL 
09831191020

drjaydeep_choudhury@yahoo.co.in 
Dr Sonali Kar  Kalinga Institute of Medical Sciences, Bhubaneswar  Department of Community Medicine, Kalinga Institute of Medical Sciences, KIIT campus - 5, Patia, Bhubaneswar
Khordha
ORISSA 
9438423273

sonsam72@yahoo.co.uk 
Dr Sciddhartha Koonwar  King George’s Medical University, Lucknow  Room No. 401, 3rd floor, Department of Pediatrics, King George’s Medical University
Lucknow
UTTAR PRADESH 
09415102691

dr_sciddhartha@yahoo.com 
Dr Mamta Vijay Manglani  Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai  OPD No. 7 (Pediatrics OPD),1st floor, Department of Pediatrics, Lokmanya Tilak Municipal Medical College & General Hospital, Sion
Mumbai
MAHARASHTRA 
09821322071

mmanglani@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethics Committee - Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata – 700017  Approved 
Ethics Committee, GMERS Medical College Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad-380061, Gujarat  Approved 
Institutional Ethics Committee – Gandhi Medical College / Hospital, Musheerabad, Secunderabad – 500003  Approved 
Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar  Approved 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, KIIT Campus – 5, Bhubaneswar, Orissa  Approved 
Institutional Ethics Committee, King George Hospital, Visakhapatnam - 530002, Andhra Pradesh  Approved 
Institutional Ethics Committee, King George’s Medical College, Office of Research Cell, Administrative Block, King George’s Medical University, Lucknow, Uttar Pradesh  Approved 
Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC), Staff and Research Society, L.T.M. Medical College Building, Sion, Mumbai - 400 022  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Primary immunization against Diphtheria, Tetanus & Pertussis 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Ltd.  Subject will receive three doses (0.5 ml each) of Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) administered as intramuscular injection in the anterolateral aspect of the upper thigh with 28 days interval between successive doses. The subject will receive a total of 3 doses of test vaccine & will be followed up till 28 days after the last dose of vaccine 
Comparator Agent  Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) of M/s Serum Institute of India Ltd.  Subject will receive three doses (0.5 ml each) of Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) administered as intramuscular injection in the anterolateral aspect of the upper thigh with 28 days interval between successive doses. The subject will receive a total of 3 doses of reference vaccine & will be followed up till 28 days after the last dose of vaccine 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  1. Healthy infant of either gender between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) at the time of enrollment
2. Subject born after a normal gestational period of 37-42 weeks with birth weight ≥ 2.5 Kg
3. Body weight ≥ 3.3 Kg at the time of enrollment
4. Subject in a good clinical condition as judged by the investigator based on medical history and physical examination
5. Written informed consent obtained from the subject’s parents or legally acceptable representative
6. Subject’s parents or legally acceptable representative literate enough to fill the diary card 
 
ExclusionCriteria 
Details  1. Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine
2. Past history of diphtheria, pertussis or tetanus
3. History of known or suspected allergy to any of the vaccine components
4. History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy
5. Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy
6. Subject with history of clinically significant systemic disorder especially neurological disorder
7. Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity
8. History of any acute illness within the past 1 week
9. Subject with febrile illness (axillary temperature ≥ 37.5 0C) at the time of enrollment
10. Planned or elective surgery during the course of the study
11. History of administration of blood, any blood containing product or immunoglobulins since birth
12. Participation of subject in any clinical trial since birth or participation of subject’s mother in any clinical trial within the past 30 days 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84  28 days following last vaccination (day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Geometric mean titre of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at baseline and at day 84  28 days following last vaccination (day 84) 
 
Target Sample Size   Total Sample Size="282"
Sample Size from India="282" 
Final Enrollment numbers achieved (Total)= "288"
Final Enrollment numbers achieved (India)="288" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/05/2015 
Date of Study Completion (India) 27/02/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of DPT vaccine of M/s Cadila Healthcare Ltd. with DPT vaccine of M/s Serum Institute of India Ltd. in healthy infants. Blood samples will be collected pre-vaccination (day 0) & at 28 days after last vaccination (day 84) to determine anti-diphtheria, anti-tetanus and anti-pertussis antibody titres. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies post-vaccination. The sero-protective cut-off titre for serum anti-diphtheria & anti-tetanus antibodies is 0.1 IU/ml. The sero-protective cut-off titre considered for serum anti-pertussis antibodies is 22 U/ml.  The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study. 
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