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CTRI Number  CTRI/2017/11/010427 [Registered on: 08/11/2017] 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   A clinical study to assess and compare the immune response and safety of two different pentavalent vaccines (vaccine given to protect against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae) in healthy children 
Scientific Title of Study   A prospective, randomized, two-arm, single-blind, parallel, active-controlled, multicenter, non-inferiority clinical study to evaluate the immunogenicity and safety of Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) of M/s Cadila Healthcare Limited compared to Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) of M/s Panacea Biotec Limited in healthy infants 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
16-07; Version No. 00; Dated 28/12/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Mittal 
Designation  Medical Advisor & Head - Regulatory Affairs 
Affiliation  Cadila Healthcare Ltd., Ahmedabad 
Address  Cadila Healthcare Ltd., Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad, Gujarat, India

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 Affairs 
Affiliation  Cadila Healthcare Ltd., Ahmedabad 
Address  Cadila Healthcare Ltd., Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad, Gujarat, India

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  Senior Manager – New Product Development 
Affiliation  Cadila Healthcare Ltd., Ahmedabad 
Address  Cadila Healthcare Ltd., Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad, Gujarat, India

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 CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad – 380015, Gujarat, India  
 
Primary Sponsor  
Name  Cadila Healthcare Ltd 
Address  Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad – 380015, Gujarat, 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 = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeta Hanumante  Bharati Hospital, Pune  Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College & Hospital, Katraj, Dhankawadi, Pune – 411043, Maharashtra
Pune
MAHARASHTRA 		 02024364308

researchpedpune@gmail.com 
Dr K Siva Ram Prasad  Gandhi Hospital, Secunderabad  Study room, 1st floor, main hospital building, Department of Pediatrics, Gandhi Hospital, Musheerabad, Secunderabad – 500003, Telangana
Hyderabad
ANDHRA PRADESH 		 09440424545

sivaram175@yahoo.com 
Dr Vishal Gajimwar  Government Medical College & Hospital, Nagpur  Research Room, Ward No. 3, Department of Pediatrics, Government Medical College and Hospital, Medical College Square, Nagpur – 440003, Maharashtra
Nagpur
MAHARASHTRA 		 09822938202

drvishalgajimwar@gmail.com 
Dr Monjori Mitra  Institute of Child Health, Kolkata  Room No. 113, Ground floor, Institute of Child Health, 11, Dr. Biresh Guha Street Kolkata – 700017, West Bengal
Kolkata
WEST BENGAL 		 09831075734

monjorimr@gmail.com 
Dr Sciddhartha Koonwar  King George’s Medical University, Lucknow  Room No. 505, Fifth floor, Kalam Centre, Department of Pediatrics, King George’s Medical University, Lucknow – 226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 09415102691

dr_sciddhartha@yahoo.com 
Dr N Ravi Kumar  Niloufer Hospital, Hyderabad  Research Room, Department of Pediatrics, OPD Building, Niloufer Hospital, Red Hills, Lakdikapool, Hyderabad – 500004, Telangana
Hyderabad
ANDHRA PRADESH 		 09490919293

ravik1961@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee, Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata-700017, West Bengal  Approved 
Institutional Ethics Committee, Bharati Vidyapeeth Deemed University, Bharati Hospital & Research Centre, Pune – Satara Road, Katraj, Dhankawadi, Pune – 411043, Maharashtra  Approved 
Institutional Ethics Committee, Department of Pharmacology, Government Medical College, Nagpur – 440003, Maharashtra  Approved 
Institutional Ethics Committee, Gandhi Medical College & Hospital, Musheerabad, Secunderabad – 500003, Telangana  Approved 
Institutional Ethics Committee, Office of Research Cell, Administrative Block, King Georges Medical University, Lucknow-226003, Utter Pradesh  Approved 
Institutional Ethics Committee, Osmania Medical College, Koti, Hyderabad – 500095, Telangana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Primary immunization against Diphtheria, Tetanus, Pertussis, Hepatitis B & Haemophilus influenzae type b 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd.  The subjects will receive three doses (0.5 ml each) of the vaccine administered as intramuscular injection in the anterolateral aspect of the upper thigh taking care of aseptic precautions with 4 weeks interval between the successive doses. The subjects will be followed till 4 weeks after receipt of third dose of the vaccine. 
Comparator Agent  Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) I.P. of M/s Panacea Biotec Ltd.  The subjects will receive three doses (0.5 ml each) of the vaccine administered as intramuscular injection in the anterolateral aspect of the upper thigh taking care of aseptic precautions with 4 weeks interval between the successive doses. The subjects will be followed till 4 weeks after receipt of third dose of the 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 parent
6.Subject’s parent literate enough to fill the diary card 
 
ExclusionCriteria 
Details  1.Any vaccination before enrollment except vaccination given at birth such as BCG vaccine, Hepatitis-B vaccine and oral polio vaccine
2.Past history of diphtheria, tetanus, pertussis, hepatitis B or Haemophilus influenzae type b
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 ≥37.5oC) at the time of Enrollment
10.Planned or elective surgery during the course of the study
11.History of administration of blood, any blood 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, anti-pertussis, anti-HBs and anti-PRP antibodies at the end of the study  28 days post-vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Geometric mean titre of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodies at the baseline and at the end of the study  28 days post-vaccination 
Local and systemic adverse events  Throughout study duration 
Serious adverse events  Throughout study duration 
Overall tolerability evaluation  28 days post-vaccination 
 
Target Sample Size   Total Sample Size="314"
Sample Size from India="314" 
Final Enrollment numbers achieved (Total)= "314"
Final Enrollment numbers achieved (India)="314" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/11/2017 
Date of Study Completion (India) 08/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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 Pentavalent (DTwP-HepB-Hib) vaccine of M/s Cadila Healthcare Ltd. [Test vaccine] with Pentavalent (DTwP-HepB-Hib) vaccine of M/s Panacea Biotec Ltd. [Reference vaccine] in healthy infants. A minimum of 314 subjects will be enrolled in this study and will receive either study vaccine as per the central computer generated randomization plan. Three doses (0.5 ml each) of the allocated study vaccine will be administered to clinical trial subjects keeping an interval of 4 weeks between successive doses as per the recommended immunization schedule. Two blood samples will be collected; once pre-vaccination (on day 0) & another post-vaccination (day 84; at least 28 days after third dose of the vaccine) to evaluate anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibody titres. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for the proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodies post-vaccination. The sero-protective cut-off titre considered is 0.1 IU/ml for serum anti-diphtheria & anti-tetanus antibodies, 22 U/ml for serum anti-pertussis antibodies, 10 mIU/ml for serum anti-HBs antibodies; and 0.15 mcg/ml (for short-term protection) & 1.0 mcg/ml (for long-term protection) for serum anti-PRP antibodies. In addition, baseline (pre-vaccination) and end of study (post-vaccination) geometric mean titre of the above antibodies will also be calculated for both the study groups. 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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