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CTRI Number  CTRI/2010/091/001128 [Registered on: 11/08/2010]
Last Modified On: 08/03/2013
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study
Modification(s)  
Vaccine 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
A Phase IV Clinical Study to Evaluate the Safety and Efficacy of ComVac5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of Bharat Biotech) 
Scientific Title of Study
Modification(s)  
A Phase IV, Multicentric, Controlled, Open labeled, Study to Evaluate the Safety and Immunogenicity of ComVac5 (DTwP-Hep-B-Hib-Liquid Pentavalent vaccine of BBIL) Vs. Reference Vaccine in healthy subjects  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BBIL/PENTA-PMS/2009  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anit Singh 
Designation   
Affiliation   
Address  Assistant Medical Director, Clinical & Regulatory Affairs Dept, Bharat Biotech.

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  anits@bharatbiotech.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Anit Singh 
Designation   
Affiliation   
Address  Assistant Medical Director, Clinical & Regulatory Affairs Dept, Bharat Biotech.

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  anits@bharatbiotech.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Anit Singh 
Designation   
Affiliation   
Address  Assistant Medical Director, Clinical & Regulatory Affairs Dept, Bharat Biotech.

Hyderabad
ANDHRA PRADESH
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  anits@bharatbiotech.com  
 
Source of Monetary or Material Support
Modification(s)  
Bharat Biotech International Limited, Genome Valley, Shameerpet, Ranga Reddy (Distict), Hyderabad-500 078.  
 
Primary Sponsor
Modification(s)  
Name  Bharat Biotech International Limited 
Address  Genome Valley, Shameerpet, Ranga Reddy (District), Hyderabad-500 078.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Not Applicable   
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
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No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. P. Venu Gopal  1. King George Hospital  Professor of Pediatrics, King George Hospital, ,-530002

 
+91891 2748651

venugopal_kgh@yahoo.com 
Dr J Venkateswara Rao  Gandhi Hospital  Professor of Pediatrics, Gandhi Hospital, Secunderabad,,-500003.
Hyderabad
ANDHRA PRADESH 
914027754777

drjvrao@yahoo.co.in 
Dr Krishna Murthy  Mysore Medical College & Research Center  Professor of Pediatrics, Cheluvambha Hospital, Irwin Road,-570001
Mysore
KARNATAKA 
919844034690
918212520803
bkm6@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Human Ethics Committee  Approved 
Institutional Ethics Committee, King George Hospital, Visakhapatnam   Approved 
Mysore Medical College & Research Center, Mysore  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Prevention of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b (Hib) 
 
Intervention / Comparator Agent
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Type  Name  Details 
Comparator Agent  Easy5  Same as Intervention vaccine 
Intervention  Liquid Pentavalent Vaccine - Comvac5  0.5mL per dose, 3 doses  
 
Inclusion Criteria
Modification(s)  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  1)Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures and visits.
2)Healthy male or female infant aged 6 to 8 weeks at the time of screening/enrollment.
3)Subjects who are healthy without any history of DTP and Hib vaccination. (As Hepatitis B vaccination is often done at birth, history of immunization against Hepatitis B at birth is not a parameter for exclusion but the fact is recorded in the case record form).
4)Infant who is HBsAg negative.
5)Subjects should have been born after 36-week term and are not less than 3200 gms, at the time of inclusion.
 
 
ExclusionCriteria 
Details  1)Fever of any origin of duration more than 3 days prior to/at screening visit.
2)Past history of DTP & Hib vaccination.
3)History of acute or chronic auto immune disease.
4)Any confirmed or suspected immunosuppressive condition.
5)Any treatment with immunosuppressive or immuno stimulant therapy
6)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP Hepatitis B and Hib.
7)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
8)Known hypersensivity reactions to any of the components of the vaccine.
 
 
Method of Generating Random Sequence
Modification(s)  
Computer generated randomization 
Method of Concealment
Modification(s)  
An Open list of random numbers 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
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Outcome  TimePoints 
To evaluate the safety and immunogenicity of ComVac-5 (DTwP-Hep-B-Hib, Liquid Pentavalent vaccine of BBIL) Versus reference WHO Pre-Qualified vaccine, in healthy subjects of age 6-8 weeks at time of enrollment as a non-inferiority trial.

Immunogenicity
Seroconversion
Seroprotection
 
3 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Safety: monitoring of all local and systemic Adverse Events (solicited and unsolicited) following vaccination throughout the study period of 3 months.
2. To demonstrate lot to lot consistency between three different batch of test vaccine
 
Throughout the study period.  
 
Target Sample Size
Modification(s)  
Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  
Phase 4 
Date of First Enrollment (India)
Modification(s)  
21/07/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
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
Modification(s)  
not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The study will be a phase IV, multicentric randomized, controlled , open label, non-inferiority trial to assess safety and immunogenicity of the study vaccine versus the reference vaccine in healthy Indian children. A total of 300 needs to be vaccinated - 225 in the test arm and 75 in the control arm at the ratio of 3:1.The multicentric study will be at carried out at various centers in India. Primary Objective is to compare and demonstrate that the Immunogenicity and safety of the investigational product ComVac-5, is not clinically inferior to that of the WHO Pre-Qualified Reference Vaccine, in healthy subjects. Secondary Objective is Assessment of Safety:  The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events ( local and systemic reactions) 4 weeks post vaccination with an intensive initial monitoring phase of 30 minutes post vaccination. Monitoring of safety would include all solicited and unsolicited AE and Vaccine consistency: To demonstrate lot to lot consistency between three different batches of the test vaccine. 
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