| CTRI Number |
CTRI/2011/11/002118 [Registered on: 11/11/2011] Trial Registered Prospectively |
| Last Modified On: |
29/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to Assess the
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine
DTwP-Hib-HepB in Indian infants |
|
Scientific Title of Study
|
A Ph III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem (DTwP-Hib-HepB Vaccine) when Administered to Indian Infants at 6, 10, and 14 Weeks of Age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| V66_05 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Hoshang Vakil |
| Designation |
Medical Director |
| Affiliation |
Novartis Healthcare Pvt Ltd |
| Address |
Novartis Healthcare Pvt Ltd
Vaccines Division
Mumbai
MAHARASHTRA
400018
India |
| Phone |
912266930860 |
| Fax |
912266930813 |
| Email |
hoshang.vakil@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha J |
| Designation |
Clinical Operations Manager, India |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited
Vaccines and Diagnostics
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
914067674381 |
| Fax |
914067671500 |
| Email |
rekha.j@novartis.com |
|
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Source of Monetary or Material Support
|
| Novartis Healthcare Private Limited, 501, Shree Amba Shanti Chambers,Andheri Kurla Road, Next to Leela Business Park, Andheri (East)Mumbai-400059, Maharashtra,INDIA India |
| Novartis Vaccines |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd Vaccines Division |
| Address |
Sandoz House, Dr. Annie Besant Road, Mumbai,Maharastra-400018 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Lalwani |
Bharati Hospital and Research Center |
Department of Pediatrics, Katraj, Dhankawadi
Pune 411043
INDIA
Pune
MAHARASHTRA |
912024364308
912024375541
sanjaylalwani2007@rediffmail.com |
| Dr Sukanta Chaterjee |
Medical College Kolkata |
Department of pediatrics, 88 College Street Kolkata
Kolkata
WEST BENGAL |
913322414901
913322198118
sukantachatterjee@hotmail.com |
| Dr Adarsh Eregowda |
Rajarajeshwari Medical College & Hospital |
Department of pediatrics, College campus,Kambipura, Mysore Road, Kengeri Hobli, Bangalore, Karnataka-560074
Bangalore
KARNATAKA |
918026756530
918026756531
dradarsh.d2l@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research, Medical College Hospital, Kolkata |
Approved |
| Institutional Ethics Committee, Bharathi Vidyapeeth University |
Approved |
| Institutional Ethics committee, Rajarajeshwari Medical College & Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Seroprotection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Quinvaxem vaccine |
3 doses of 0.5ml at 6, 10,14 weeks of age. Route of administration Intramuscular |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
64.00 Day(s) |
| Gender |
Both |
| Details |
Healthy infants without any contradictions to receive investigational vaccine |
|
| ExclusionCriteria |
| Details |
1.Parents unwilling or unable to provide written informed consent
2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
3.Known hypersensitivity or allergic reactions after previous vaccinations
4.Presence of any significant medical condition |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Immunogenicity Endpoints:
Seroprotection rates one month after the last dose of vaccine administration |
one month after the third study injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety Endpoints:
Safety and Tolerability |
after vaccination |
| GMCs one month after last dose of vaccine administration |
one month after the third study injection |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2011 |
| 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
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is a Phase III, single arm, multicentre, open label study to evaluate immunogenicity, safety and tolerability of 3 doses of a pentavalent vaccine administered to Indian infants at approximately 6, 10 and 14 weeks of age. The study will be conducted in 4 centers in India. DTwP-HepB-Hib is a fully liquid vaccine combining Diphtheria, Tetanus, whole cell Bordetella pertussis (B. pertussis), Hepatitis B (HepB), and Haemophilus influenzae type b (Hib) antigens. The primary immunogenicity objective of the study is to assess the seroprotective titers to diphtheria, tetanus, HepB, B.pertussis and Hib one month after third study injection. Secondary Immunogenicity Objective is to evaluate geometric mean concentration (GMCs) against diphtheria, tetanus, B.pertussis, HepB and Hib antigens one month after third study injection, The safety objective is to evaluate the safety and tolerability of Quinvaxem vaccine administered to infants at Days 1, 29 and 57 of the study.
7 Feb 2012: Study is not initiated at site 03, No Subjects recruited at this site. |