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CTRI Number  CTRI/2009/091/000616 [Registered on: 28/08/2009]
Last Modified On: 23/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to assess the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants. 
Scientific Title of Study   A Phase IV, Open label, Randomised, Comparative, Parallel group, Clinical Study to Evaluate the immunogenicity and Safety of two different formulations of Haemophilus Influenzae Type-B Vaccine (SII HibPRO) of Serum Institute of India Limited in Indian Infants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Hib-02/08  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Prasad Kulkarni 
Designation   
Affiliation   
Address  Serum Institute of India Ltd
212/2, Hadapsar
Pune
MAHARASHTRA
411028
India 
Phone  020-26602384  
Fax  020-26993945  
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prasad Kulkarni 
Designation   
Affiliation  Serum Institute of India Ltd 
Address  Serum Institute of India Ltd
212/2, Hadapsar
Pune
MAHARASHTRA
411028
India 
Phone  020-26602384  
Fax  020-26993945  
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr. Prasad Kulkarni 
Designation   
Affiliation   
Address  Serum Institute of India Ltd
212/2, Hadapsar
Pune
MAHARASHTRA
411028
India 
Phone  020-26602384  
Fax  020-26993945  
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Ltd 
 
Primary Sponsor
Modification(s)  
Name  Serum Institute of India Ltd 
Address  212/2, off Soli Poonawalla Road, Hadapsar, Pune 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. KrishnaMurthy B   Cheluvamba Hospital, Mysore Medical College and Research Institute, Mysore  Department of Pediatrics,,Cheluvamba Hospital, Mysore Medical College and Research Institute, -570001
Mysore
KARNATAKA 		 +91- 8212520512
+91-91 821 2520803
bkm6@rediffmail.com  
Dr. Sharad Agarkhedakar   Dr. D. Y. Patil Medical College, Pune  Dr. D. Y. Patil Medical College, Pune,-411 018
Pune
MAHARASHTRA 		 02027423693
020274230122
ashalaka@rediffmail.com 
Dr. Dulari Gandhi   SBKS Medical College and Dhiraj General Hospital, Piparia, Varodara.   Department of Pediatrics,,SBKS Medical College and Dhiraj General Hospital, -391760

 		 +91-2668 391760

djg_48@yahoo.co.in  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee of Mysore Medical College and Research Institute, Mysore  Approved 
Ethics Committee, Sumandeep Vidyapeeth University, Vadodara  Approved 
Instititional Ethics Committee, Padmashree Dr. D.Y. Patil Pratishthan Hospital and Research Centre, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Prevention of H. influenzae type-B infection  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  H. Influenzae Type B vaccine of SIIL (SII HibPro)  3 doses of 0.5 ml at 6, 10 and 14 weeks of age 
Comparator Agent  Other formulation of H. Influenzae Type B vaccine of SIIL (SII HibPro)  3 doses of 0.5 ml at 6, 10 and 14 weeks of age 
 
Inclusion Criteria
Modification(s)  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  1) Normal healthy infants of age 6-8 weeks at the time of first vaccination 2) Parents of subject willing to give written informed consent 3) Free of obvious health problems as established by medical history and physical examination. 
 
ExclusionCriteria 
Details  1) Infant subject participating in other clinical trial. 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy. 3) Infant with history of allergy or systemic hypersensitivity. 4) Infant with any chronic illness. 5)Infant who received blood or blood derived products in the past. 6) Known history of a bleeding disorder 7) Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or making it unlikely the subject could complete the protocol 8) History of febrile illness is a temporary exclusion criterion. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Immunogenicity- Long term seroprotection   On day 0 and 84.  
 
Secondary Outcome  
Outcome  TimePoints 
Safety: Occurrence of any solicited adverse reaction, unsolicited adverse event or any serious adverse event. Immunogenicity: Short term Seroprotection   Safety assessment on day 0, 28, 56 and 84. Immunogenicity assessment on day 0 and 84.  
 
Target Sample Size
Modification(s)  		 Total Sample Size="218"
Sample Size from India="218" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  23/02/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="0"
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
Modification(s)  		 The study is initiated after ethics committee approval from the respective study centers. Eligible subjects receive 0.5 ml of SII HibPRO vaccine of either formulation at 6, 10 and 14 weeks of age. The parents/legal guardians are informed to visit the study centre 1 month after each dose of study vaccine. At each visit, the subjects are physically examined and history is asked for adverse events (AE) and concomitants medications. 3 ml of blood is collected at baseline and at 1 month after the third dose. Serum samples will be tested for anti-PRP antibodies. 
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