CTRI Number |
CTRI/2010/091/001128 [Registered on: 11/08/2010] |
Last Modified On: |
08/03/2013 |
Post Graduate Thesis |
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Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
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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)
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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 |
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Secondary IDs if Any
Modification(s)
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Secondary ID |
Identifier |
BBIL/PENTA-PMS/2009 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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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 |
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Details of Contact Person Scientific Query
Modification(s)
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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)
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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)
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Bharat Biotech International Limited, Genome Valley, Shameerpet, Ranga Reddy (Distict), Hyderabad-500 078. |
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Primary Sponsor
Modification(s)
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Name |
Bharat Biotech International Limited |
Address |
Genome Valley, Shameerpet, Ranga Reddy (District), Hyderabad-500 078. |
Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
Modification(s)
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Name |
Address |
Not Applicable |
|
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Countries of Recruitment
Modification(s)
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India |
Sites of Study
Modification(s)
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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 |
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Details of Ethics Committee
Modification(s)
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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 |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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Health Type |
Condition |
Healthy Human Volunteers |
Prevention of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b (Hib) |
|
Intervention / Comparator Agent
Modification(s)
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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 |
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Inclusion Criteria
Modification(s)
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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.
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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.
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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An Open list of random numbers |
Blinding/Masking
Modification(s)
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Open Label |
Primary Outcome
Modification(s)
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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 |
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Secondary Outcome
Modification(s)
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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
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Throughout the study period. |
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Target Sample Size
Modification(s)
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Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
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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)
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Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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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. |