| CTRI Number |
CTRI/2009/091/000394 [Registered on: 02/07/2009] |
| Last Modified On: |
12/12/2014 |
| 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
Modification(s)
|
A clinical trial to assess immunogenicity and safety of combination vaccine (DTwP-HB) as compared with Active Comparator (DTPw-HB) and to demonstrate the equivalence of three different lots of LBVW0101, in healthy infants at 6, 10 and 14 weeks of age. |
Scientific Title of Study
Modification(s)
|
A prospective, multicentre, comparative, double blind, randomized phase III study to assess immunogenicity and safety of LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis- Hepatitis B) compared with Tritanrix HB® (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy infants at six, ten, and fourteen weeks of age. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LG-VACL 102 |
Protocol Number |
| U1111 - 1111 - 2397 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
Deputy General Manager |
| Affiliation |
Project Leader |
| Address |
LG Life Sciences India Pvt Ltd, Plot no 11, Sector 44
Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
deepali.mittal@lglsi.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
Deputy General Manager |
| Affiliation |
Project Leader |
| Address |
LG Life Sciences India Pvt Ltd.
Plot No 11, Sector 44, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
deepali.mittal@lglsi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
Deputy General Manager |
| Affiliation |
Project Leader |
| Address |
LG Life Sciences India Pvt Ltd.
Plot No 11, Sector 44, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
deepali.mittal@lglsi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| LG Life sciences Ltd.
Plot No 11, Sector 44, Gurgaon 122001, Haryana |
|
Primary Sponsor
Modification(s)
|
| Name |
LG Life Sciences Ltd |
| Address |
LG Gwanghwamun Bldg.
58 Saemunan-ro, Jongno-gu, Seoul, 110-062, South Korea
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| NIL |
|
| NIL |
|
| None |
Not applicable |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavana B Lakhkar |
Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru medical college,Wardha, Maharashtra |
Department of Pediatrics, 82 sahastrabudhe layout,bharat nagar amaroti road-442004
Nagpur
MAHARASHTRA |
9960216199
blakhkar@yahoo.co.in |
| Dr D Rammohan Rao |
Deccan Medical College, DMRL X Roads,kanchanbagh,Hyderabad, Andhra Pradesh-500 058 |
Department of Pediatrics, G-36, Madhura Nagar,.R. Nagar Post Office-500 058
Hyderabad
ANDHRA PRADESH |
243431290
rmrdesina@gmail.com |
| Dr VN Tripathi |
G.S.V.M.Medical College, Associated LLR Children Hospital,Kanpur,Uttar Pradesh-208002 |
P 5, Department of Pediatrics, Medical College Campus,-208002
Kanpur Nagar
UTTAR PRADESH |
9415050777
drvntripathi@gmail.com |
| Dr Dipty L Jain |
Government Medical College & Hospital, Nagpur, Maharashtra -440 003 |
Department of Pediatrics, GMC Hospital, ,-440 003
Nagpur
MAHARASHTRA |
0712-2750165
jdipty@rediffmail.com |
| Dr PP Maiya |
M.S. Ramaiah Medical College, Bangalore, Karnataka-560054 |
Department of Pediatrics, M.S. Ramaiah Medical college,-560054
Bangalore
KARNATAKA |
080-40528403
p_maiya@hotmail.com |
| Dr Hemant Jain |
Mahatma Gandhi Medical College, Chacha Nehru Hospital,M.Y.H. Compound Indore, Madhya Pradesh-452001 |
Department of Pediatrics,11/2, South tukoganj,Swapna Lok Colony, Behind Surya,-452001
Indore
MADHYA PRADESH |
0172-275533
jainapeksha@hotmail.com |
| Dr A Amaresh |
Niloufer Hospital for Women & Children,Institute of Child health,Hyderabad, Andhra Pradesh-500 004 |
Department of Pediatrics, 6-3-119, Aditya elite, C-Block ,203,kirtilal Jewelers lane-500 004
Hyderabad
ANDHRA PRADESH |
040-23407677
adyaramaresh@yahoo.com |
| Dr Praveen Kumar |
Post Graduate Institute of Medical Education and Research, Chandigarh, Haryana-160012 |
Department of Pediatrics, 125 C,Sector 24 A-160012
Chandigarh
CHANDIGARH |
0172-275533
drpkumarpgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethical Review Board M.S. Ramaiah Medical College and Teaching Hospital, Bangalore, Karnataka -560054. |
Approved |
| Ethics Committee Niloufer Hospital for Women & Children, Institute of Child health, Red Hills, Bazar Ghat, Hyderabad, Andhra Pradesh -500 004. |
Approved |
| Ethics Committee G.S.V.M. Medical College, Kanpur, Uttar Pradesh-208002. |
Approved |
| Institute Ethics Committee Post Graduate Institute of Medical Education and Research, Chandigarh, Haryana-160012. |
Approved |
| Institutional Ethical Committee Centre for Liver Research and Diagnostic Deccan Medical College of Medical Sciences, Hyderabad, |
Approved |
| Institutional Ethics Committee Government Medical College & Hospital, Nagpur, Maharashtra-440 003. |
Approved |
| Institutional Ethics Committee,Datta Meghe Institution of Medical Sciences, Sawangi (Meghe) Wardha-Maharashtra-442004. |
Approved |
| M.G.M. Medical College & Associated Society, Indore, Madhya Pradesh-452001. |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prophylaxis of diphtheria, tetanus, pertussis and hepatitis B infection |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
LBVW0101 |
3 Doses of 0.5mL each at 6 weeks, 10 weeks and 14 weeks by intramuscular injection on right thigh. |
| Comparator Agent |
Tritanrix HB® (Combined DTPw-HB Vaccine) |
3 Doses of 0.5mL each at 6 weeks, 10 weeks and 14 weeks by intramuscular injection on right thigh. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1. Healthy infants of either sex who have reached at least 42
days of age and not more than 56 days of age at the time of enrollment
2. Born at full term of pregnancy 3. Body weight more than 3.2kg at enrollment
4. Born to HBsAg negative mother
5. Not previously received any dose of HB and DTP
6. Able to comply with visit schedule
7. Signed informed consent by subject Legally Acceptable
Representative |
|
| ExclusionCriteria |
| Details |
Subjects are not eligible for enrollment if any of the following criteria are met:
1. History of previous or concurrent vaccinations other than
Bacillus Calmette-Guerin (BCG) or Oral Polio Vaccine (OPV) at
birth.
2. Known or suspected disease history of hepatitis B, diphtheria,
pertussis, or tetanus.
3. Planned administration of a vaccine not foreseen by the study
protocol, with the exception of OPV, Hib or BCG vaccine (if not
administered at birth), which may be administered during the
course of study according to local Expanded Programme on
Immunization (EPI) schedule.
4. LAR is unwilling or unable to give written informed consent to
participate in the study.
5.Household contact and/or intimate exposure in the previous 30
days to an individual with ascertained HB, diphtheria or
pertussis.
6.Experienced fever ≥37.5°C/ 99.5°F within the past
three days.
7. Experienced significant acute or chronic infections requiring
systemic antibiotic treatment or antiviral therapy within the
past 7 days.
8. Known or suspected impairment of the immune function,
receiving immunosuppressive therapy, or having received
immunosuppressive therapy within 30 days prior to study
entry (ex. systemic corticosteroid). However, treatment with
corticosteroids (prednisolone equivalent≤0.5
mg/kg/day) not more than 14 consecutive days prior to those
30 days will not be an exclusion criterion.
9. Received a parenteral immunoglobulin preparation and/or
blood product since birth.
10.History of allergy considered due to any vaccine component,
including excipients and preservatives.
11. Evidence of significant haematological, cardiac, hepatic, renal,
neurological, respiratory, metabolic disease or any condition
which, in the opinion of the Investigator, might interfere with
the evaluation of the study objectives.
12 Participation in another trial or received any investigational
product 30 days prior to enrollment or simultaneous
participation in another clinical study.
13. Infants whose families are planning to leave the area of the
study site before the end of the study period.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Comparison of immunogenicity as measured by seroprotection /vaccine response rates through evaluation of anti-HBs, anti-diphtheria, anti-tetanus, anti-pertussis antibodies at four weeks post final immunization in the LBVW0101 and Active Comparator (Combined DTPw-HB Vaccine) groups |
At the end of four weeks
(Post- Vaccination) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| A. Seroprotection/vaccine response rates in the three lots B.GMTs C. incidence of solicited local reactions,systemic events and unsolicited events respectively. |
At the end of four weeks
(Post- Vaccination) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="492"
Sample Size from India="492"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/02/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/02/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, multicentre, comparative, parallel, double-blind, randomised phase III study to assess immunogenicity and safety of LBVW0101 (Combined DTwP-HB vaccine) compared with Active Comparator Tritanrix-HB (Combined DTPw-HB Vaccine) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy 492 subjects. (infants at six, ten and fourteen weeks of age). |