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CTRI Number  CTRI/2016/01/006541 [Registered on: 19/01/2016] Trial Registered Prospectively
Last Modified On: 29/12/2020
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 trial to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine in Healthy Infants 
Scientific Title of Study   A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine when Administered in Three Doses to 6-8 weeks old Healthy Infants 
Trial Acronym  Pentavalent Phase III Clinical trial 
Secondary IDs if Any  
Secondary ID  Identifier 
HBI/Penta/III/2015/001.01 Ver 01 Amend 01 Dated 31Aug2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Sai Krishna 
Designation  Manager Medical Services 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India
Rangareddi
ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Sai Krishna 
Designation  Manager Medical Services 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India

ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Details of Contact Person
Public Query  
Name  Dr S Sai Krishna 
Designation  Manager Medical Services 
Affiliation  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad India

ANDHRA PRADESH
500032
India 
Phone  8187836444  
Fax    
Email  s.saikrishna@indimmune.com  
 
Source of Monetary or Material Support  
Human Biologicals Institute 
 
Primary Sponsor  
Name  Human Biologicals Institute 
Address  Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram Gachibowli Hyderabad 500032 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 = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Ramesh Babu  Gandhi Medical College and Hospital  Department of Pediatrics, Gandhi Medical College and Hospital, Musheerabad, Secundrabad-500003
Hyderabad
ANDHRA PRADESH 		 9247119597

ramesh_ped@yahoo.com 
Dr Rajib Kumar Ray  Hi-Tech Medical College and Hospital  Department of Paediatrics, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar, Odisha- 751025
Khordha
ORISSA 		 9338089618

drrajib2007@gmail.com 
Dr M D Ravi  JSS Medical College & Hospital  Department of Pediatrics, JSS Medical College & Hospital, Mysore, Karnataka-570015
Mysore
KARNATAKA 		 9880629506

ravimdped@gmail.com 
Dr Sheila Bhave  KEM Hospital Research Centre  KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,Pune-411011, Maharashtra
Pune
MAHARASHTRA 		 9823091871

kemhrc@vsnl.com 
Dr Rajat Kumar Das  KPC Medical College and Hospital  Department of Paediatrics, KPC Medical College and Hospital, 1F, Raja Subodh Chandra Mullick Road, Jadavpur, Kolkata- 700032 West Bengal
Kolkata
WEST BENGAL 		 9163891439

rkdforped@gmail.com 
Dr Mukta Mantan  Maulana Azad Medical College, New Delhi  Department of Pediatrics Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi 110002
New Delhi
DELHI 		 09968604315

muktamantan@hotmail.com 
Dr B Krishnamurthy  Mysore Medical College and Research Institute  Dean and Director, Mysore Medical College and Research Institute, Mysore, Karnataka- 570001
Mysore
KARNATAKA 		 08212520512

bkm876@gmail.com 
Dr Madhu Gupta  PGIMER, Chandigarh  School of Public Health Department of Community Medicine PGIMER Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 		 07087008223

madhugupta21@gmail.com 
Dr Ramchandra Dhongade  Sant Dnyaneshwar Medical Education Research Centre  Department of Paediatrics, Sant Dnyaneshwar Medical Education Research Centre, 695/A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road, Pune – 411 030, Maharashtra
Pune
MAHARASHTRA 		 9822037483

ramdhongade@hotmail.com 
Dr Padmasani Venkat Ramanan  Sri Ramachandra Medical Centre  Department of Pediatrics, Sri Ramachandra Medical Centre, No.1, Ramchandra Nagar, Porur, Chennai- 600116
Chennai
TAMIL NADU 		 04445928900

padmasani2001@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gandhi Medical College  Approved 
Institutional Ethics Committee, Hi-Tech Medical College and Hospital  Approved 
Institutional Ethics Committee, JSS Medical College and Hospital  Approved 
Institutional Ethics Committee, KEM Hospital Research Centre  Approved 
Institutional Ethics Committee, KPC Medical College and Hospital  Approved 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
Institutional Ethics Committee, Mysore Medical College and Research Institute  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee, Sant Dnyaneshwar Medical Education Research Centre  Approved 
Institutional Ethics Committee, Sri Ramachandra University  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 Haemophillus Influenza Type B diseases  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine   Three doses of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Human Biologicals Institute will be administered by intramuscular route in the anterolateral aspect of thigh region at 4 weeks interval.  
Comparator Agent  Pentavac SD® vaccine   Three doses of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufactured by Serum Institute of India will be administered by intramuscular route in the anterolateral aspect of thigh region at 4 weeks interval. 
 
Inclusion Criteria  
Age From  1.50 Month(s)
Age To  2.00 Month(s)
Gender  Both 
Details  1. Healthy infants (as determined by medical history, physical examination and clinical judgement of the investigator) of either gender of 6-8 weeks of age at the time of first dose of vaccination.
2. Born after a normal gestational period (36 – 42 weeks) with a birth weight ≥ 2.5 kg.
3. Plans to remain in the study area for the duration of the trial.
4. Written informed consent for participation obtained prior to screening from subject’s parent/legally acceptable representative.
5. Ability of the subject’s parent/ legally acceptable representative to understand and comply with the requirements of the study.
 
 
ExclusionCriteria 
Details  1. Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
2. Planned participation in another clinical trial during the present trial period.
3. History of immunization with any vaccine other than birth dose Polio, BCG and birth dose of Hepatitis B vaccines.
4. Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination except OPV.
5. Evidence of previous infection with Diphtheria, Tetanus, Pertussis, Hepatitis B and H. influenzae.
6. History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics.
7. Known personal or maternal history of HIV or hepatitis B seropositivity.
8. Infants having any intercurrent illness.
9. History of fever with temperature > 380C (>100.40F) in last 3 days.
10. Known or suspected primary or acquired disease of the immune system.
11. Known or suspected malignancy, receipt of allergy immunotherapy, or immunosuppressive therapy.
12. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
13. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
14. Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial period.
15. Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs.
16. Any history or evidence of thrombocytopenia or a bleeding disorder or receipt of anticoagulants.
17. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
 
 
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 
• Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine.  Till 4 to 6 weeks post 3rd dose of vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Till 4 to 6 weeks post 3rd dose of vaccination.  Till 4 to 6 weeks post 3rd dose of vaccination 
 
Target Sample Size   Total Sample Size="405"
Sample Size from India="405" 
Final Enrollment numbers achieved (Total)= "405"
Final Enrollment numbers achieved (India)="405" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/01/2016 
Date of Study Completion (India) 05/10/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine when Administered in Three Doses to 6-8 Weeks Old Healthy Infants. The Primary objective is to determine the Immunogenicity i.e. the humoral immune response of individual components i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib after vaccination with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine. The Secondary objectives are: To determine that the Immunogenicity (seroconversion and seroprotection rate) of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine is not inferior to that of Pentavac SD®  vaccine group and to compare among the groups the proportion of the subjects experiencing local and/or systemic reactions during follow up period. Blood samples will be collected before the administration of first dose of vaccination and 4 to 6 weeks after the 3rd dose of the vaccination. The samples will be sent to a central lab for analysis. The study will be conducted in ten centres across India.

 
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