| CTRI Number |
CTRI/2009/091/000615 [Registered on: 04/12/2009] |
| Last Modified On: |
27/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess and compare the safety of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants. |
|
Scientific Title of Study
|
A Phase IV, Open Label, Randomized, Parallel Group, Multicentre Clinical Study To Determine And Compare Reactogenicity Of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Penta-01/08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR. SHASHANK DALVI |
| Designation |
|
| Affiliation |
|
| Address |
Department of Preventive & Social Medicine
Shri. S.C. Government Medical College
Nanded
MAHARASHTRA
India |
| Phone |
91-2462-238527 |
| Fax |
|
| Email |
shashankdddd@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PRASAD KULKARNI |
| Designation |
|
| Affiliation |
Serum Institute of India Research Foundation |
| Address |
Serum Institute of India Research Foundation
212/2, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
91-20-26602384 |
| Fax |
91-20-26993945 |
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. PRASAD KULKARNI |
| Designation |
|
| Affiliation |
|
| Address |
Serum Institute of India Research Foundation
212/2, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
91-20-26602384 |
| Fax |
91-20-26993945 |
| Email |
drpsk@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Research Foundation |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Research Foundation |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. DEEPALI AMBIKE |
Department of Pediatrics |
MIMER Medical College, ,Talegaon-410507
Pune
MAHARASHTRA |
02114228532
deepali.ambike@rediffmail.com |
| Dr. Ashok D. Rathod |
Department of Pediatrics |
Grant Medical College and Sir J. J. Group of Hospital, Byculla,-400 008
Mumbai
MAHARASHTRA |
91 22 2373 5555
adrathod@yahoo.com |
| Dr. C. S. Rajput |
Department of Pediatrics |
Bharati Vidyapeeth?s Medical College & Hospital, Wanlesswadi; Sangali-Miraj Road,-416414
Sangli
MAHARASHTRA |
260 1201
drudayrajput@gmail.com |
| Dr. C.T. Deshmukh |
Department of Pediatrics |
Seth G. S. Medical College, K.E.M. Hospital Compound, Parel,-400 012
Mumbai
MAHARASHTRA |
022-24136051
infopediatrics@kem.edu |
| Dr. Deepti Jain |
Department of Pediatrics |
Government Medical College and Hospital, Hanuman Nagar,-440 003
Nagpur
MAHARASHTRA |
0712 2743 588
dipty47@rediffmail.com |
| Dr. Mamta Manglani |
Department of Pediatrics |
Lokmanya Tilak Medical College and Lokmanya Tilak Municipal General Hospital, Sion,-400 022
Mumbai
MAHARASHTRA |
(+91 22) 4076381
(+91 22) 4076100
mmanglani@hotmail.com |
| Dr. S. S. More |
Department of Pediatrics |
Shri. S. V. Naik Govt. Medical College,-445 001
Yavatmal
MAHARASHTRA |
0723-242 456
0723-2244148
deanvngmcstudentsection@rediffmail.com |
| Dr. Sanjay K. Lalwani |
Department of Pediatrics |
Bharti Vidyapeeth University Medical College, Katraj-Dhankawadi, Satara Road,,-411 043
Pune
MAHARASHTRA |
020-2437116
020-24364308
sanjaylalwani2007@rediffmail.com |
| Dr. H.A. Khadilkar |
Department Of PSM |
Govt. Medical College, Ghati Hospital Compound, Panchakki Road,-431 001
Aurangabad
BIHAR |
0240 ? 240 2028
0240 - 240 2418
hrishikesh_khadilkar@yahoo.com |
| Dr. S.P. Rao |
Department Of PSM |
Shree B. H. Govt. Medical College, Chhakar Bardi Parisar, Malegaon Road,-424 001
Dhule
MAHARASHTRA |
02562 ? 239407
02562 ? 239 106
sprao2000@gmail.com |
| Dr. Shashank D. Dalvi |
Department Of PSM |
Shri. S.C. Govt. Medical College, Vazirabad,-431 601
Nanded
MAHARASHTRA |
02462 238527
shashankdddd@rediffmail.com |
| Dr. B. S. Garg. |
Department PSM |
Mahatma Gandhi Institute of Medical Sciences, Post Sevagram,-442 102
Wardha
MAHARASHTRA |
(91) 7152 284 341
bsgarg_ngp@sancharnet.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subject, Seth G.S.M.C. & K.E.M.H., Mumbai |
Approved |
| Ethics Committee for Research on Human Subjects, MIMER, Medical College, Talegaon, Pune |
Approved |
| Ethics Committee of Serum Institute of India Research Foundation, Pune |
Approved |
| Ethics Committee, Bharti Vidyapeeth University, Medical College and Hospital, Sangli |
Approved |
| Institutional Ethical Committee, S.S.C. G.M.C. Nanded |
Approved |
| Institutional Ethics Committee for Research on Human Subject, MGIMS, Sevagram |
Approved |
| Institutional Ethics Committee, Bharti Vidyapeeth University, Pune |
Approved |
| Institutional Ethics Committee, G.M.C. H. Nagpur |
Approved |
| Institutional Ethics Committee, GMC & Sir, JJ Group of Hospitals, Mumbai |
Approved |
| Institutional Ethics Committee, Government Medical College, Aurangabad |
Approved |
| Institutional Ethics Committee, L.T.M.C. & L.T.M.G.H., Mumbai. |
Approved |
| Institutional Ethics Committee, Shri B. Hire Government Medical College, Dhule |
Approved |
| Institutional Ethics Committee, Shri V.N. G.M.C. Yavatmal |
Approved |
| MUHS Ethics Committee for Research on Human Subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The safety of Diphtheria, Tetanus, Pertussis, Hepatitis-B and H. influenzae type-B vaccine in infants., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pentavac (DTPw-HB+Hib) vaccine of SIIL |
3 doses of 0.5 ml at 6, 10 and 14 weeks of age |
| Comparator Agent |
Tritanrix-HB-Hib of GSK |
3 doses of 0.5 ml at 6, 10 and 14 weeks of age |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1)Normal healthy infants of age 6-8 weeks at the time of the first vaccination2) Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian willing to comply with study protocol.4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.5)The participant should be the resident of study area. |
|
| ExclusionCriteria |
| Details |
1)Infant subject participating in other clinical trial or planned participation in another clinical trial 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness. 5)Infant who receive blood or blood?derived products in the past. 6)Known history of a bleeding disorder. 7)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Occurrence of solicited adverse reaction within 3 days of each vaccine dose. |
within 3 days of each vaccine dose. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1)Occurrence of unsolicited adverse events |
within 28 days following the administration of each vaccine dose. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1500"
Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
10/12/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/12/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
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)
|
1500 subjects will be screened for eligibility criteria after written informed consent from their parents/guardian. Eligible subjects will be randomized (2:1) to receive either 0.5 ml of Pentavac vaccine of SIIL or Tritanrix-HB-Hib of GSK. Study vaccine will be administered deep intramuscularly in the right anterolateral thigh. At first 3 visits (6, 10, and 14 weeks of age), the study vaccines will be administered. The parents/Legal Guardian will be informed to visit the study centre on 28th day (2nd visit), 56th day (3rd visit) and 84th day (4th visit). At each visit, the subjects will be physically examined and parents will be asked for adverse events and concomitant medication. Diaries will be collected and transcribed into Case Record Form. The study is planned in Indian Infants only. |