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CTRI Number  CTRI/2017/12/010803 [Registered on: 07/12/2017] Trial Registered Prospectively
Last Modified On: 01/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of combined vaccine for Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b in Indian children 
Scientific Title of Study   A Phase II / III, prospective, randomised, active-controlled, open label, Parallel group, 2-arm, Multi-centric trial for evaluation of Efficacy, Safety, and Tolerability of DTaP plus Hib (Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b) combination vaccine in Indian paediatric population in comparison with Pentaxim® (Diphtheria, acellular Pertussis, Tetanus, Hemophilus influenza b and IPV) combination vaccine of Sanofi Pasteur 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Agam Shah 
Designation  Head, Clinical operations 
Affiliation  Wockhardt Limited 
Address  Wockhardt Towers, Bandra Kurla complex, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596762  
Fax  02226523905  
Email  ashah@wockhardt.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sagar Katare  
Designation  Manager, Clinical Operations  
Affiliation  Wockhardt Limited 
Address  Wockhardt Towers, Bandra Kurla complex, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596763  
Fax  02226523905  
Email  skatare@wockhardt.com  
 
Details of Contact Person
Public Query  
Name  Mr Ashish Mane 
Designation  Manager, Clinical Operations  
Affiliation  Wockhardt Limited 
Address  Wockhardt Towers, Bandra Kurla complex, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596896  
Fax  02226523905  
Email  ashishm@wockhardt.com  
 
Source of Monetary or Material Support  
Wockhardt Limited, Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai  
 
Primary Sponsor  
Name  Wockhardt Limited 
Address  Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai 400051, Tel: 91 22 2653 4444, Fax: 91 22 2653 3905  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Medclin Research Pvt Ltd  Acropolis , Unit No. 10/5 , 10th floor 1858/1,Rajdanga Main Road,Kolkata-107 Phone: 033 2442 9413, Email: medclin@medclinsearch.com  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushant Mane  Grant Govt. Medical College & Sir J.J. Group of Hospitals  Department of Paediatrics, J J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai - 400008
Mumbai
MAHARASHTRA 		 0919820864049

drsush2006@gmail.com 
Dr Apurba Ghosh  Institute of Child Health  11, Dr. Biresh Guha Street, Kolkata-700017
Kolkata
WEST BENGAL 		 0913322812084

apurbaghosh@yahoo.com 
Dr P Venugopal  King George Hospital  Department of Paediatrics, Jagadamba Junction, Visakhapatnam, Andhra Pradesh 530002
Visakhapatnam
ANDHRA PRADESH 		 0919848027203

venugopal_kgh@yahoo.com 
Dr Bhaskar Shenoy  Manipal hospital  Department of Paediatrics, HAL Airport Road, Bangalore 560017
Bangalore
KARNATAKA 		 0918025023263

bshenoy@gmail.com 
Dr Piyali Bhattacharya  Sanjay Gandhi Post graduate Institute of Medical Sciences  Department of Paediatrics, Raebareli Road, Lucknow 226014
Lucknow
UTTAR PRADESH 		 0919415104073

drpiyali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of Institute of Child Health  Submittted/Under Review 
Ethics Committee of J.J. Group of Hospitals  Approved 
Ethics Committee of King George Hospital  Submittted/Under Review 
Ethics Committee of Manipal Hospital  Submittted/Under Review 
Ethics Committee of Sanjay Gandhi Post graduate Institute of Medical Sciences  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prophylaxis of Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b infections 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DTaP-Hib combination vaccine  0.5 mL/vial, 0.5 ml dose containing acellular pertussis vaccine titre ≥ 4.0 IU; diphtheria vaccine titre ≥ 30 IU; tetanus vaccine titre ≥ 40 IU. Hib conjugate vaccine: 0.5 mL/vial, 0.5 mL dose containing H influenza type b capsular polysaccharide ≥ 10 µg.  
Comparator Agent  PENTAXIM®  0.5mL/vial, 0.5 ml/ dose after reconstitution contains Diphtheria toxoid ≥ 30 IU, Tetanus toxoid ≥ 40 IU, Bordetella pertussis antigens (Toxoid & FHA) - 25 µg each; Inactivated poliomyelitis virus (Type 1, 2 and 3 - 40D, 8D and 32D antigen units respectively) Conjugated Polysaccharide of Haemophilus influenzae type b - 10 µg 
 
Inclusion Criteria  
Age From  1.50 Month(s)
Age To  2.00 Month(s)
Gender  Both 
Details  1. Full term (≥37 weeks) Indian children of either gender who have attained age ≥ 6 weeks
2. Subjects who are healthy as established by medical history & clinical examination and are eligible to receive primary immunization as per Universal Immunization Programme (UIP).
3. Parent or LAR of subject willing to give written informed consent and to comply to all study related procedures
 
 
ExclusionCriteria 
Details  1. Pre-term or Low birth weight children (≤ 2.5 kg at birth)
2. History of hypersensitivity to any of vaccines or vaccine components
3. History of any seizure / neurological or neuro-psychological disorder
4. Presence of congenital disorder /congenital infections or primary/acquired immuno-deficiency syndrome
5. Children with family history of congenital or hereditary immunodeficiency
6. History of exposure to immunosuppressive therapy after birth
7. History of HIV or HBV infection in the mother
8. Children who received blood or blood-derived products before enrolment
9. History of diphtheria, tetanus, pertussis, or Hemophilus influenza disease before enrolment or history of vaccination against diphtheria, tetanus, pertussis, or Hemophilus influenza
10. Planned administration of any other vaccine not foreseen by the study protocol within the period 30 days before inclusion or 30 days after the last dose of the vaccine except Rotavirus Vaccine, hepatitis B vaccine, Pneumococcal Conjugate Vaccine, Polio vaccine and any other vaccine given as a part of the national immunization schedule, allowed at that time of the study period.
11. Evidence of any chronic illness that could interfere with vaccine administration or evaluation
12. Planned or elective surgery during the study period.
13. Children suffering from acute febrile (> 38°C) illness / or acute non-febrile systemic illness in the past one week.
14. Children with thrombocytopenia/ bleeding disorder / any medical condition contraindicating intramuscular injections
15. Children diagnosed of blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
16. Concurrent participation in any other trial at any time during the study period
17. Any other condition, which in the opinion of the investigator might interfere with the trial conduct and completion
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Seroconversion rate to each component
2) Change in Geometric mean titers (GMT) of antibody to each component
 		 4 weeks after 3rd dose of vaccine 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events / serious adverse events post vaccination   within 30 mins and 4 weeks post vaccination 
 
Target Sample Size   Total Sample Size="342"
Sample Size from India="342" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/12/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is being designed to evaluate Efficacy, Safety, and Tolerability of DTaP plus Hib (Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b) combination vaccine in Indian pediatric population in comparison with Pentaxim® (Diphtheria, acellular Pertussis, Tetanus, Hemophilus influenza b and IPV) combination vaccine of Sanofi Pasteur administered at 6, 10 and 14 weeks of age. 
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