| CTRI Number |
CTRI/2014/04/004532 [Registered on: 09/04/2014] Trial Registered Prospectively |
| Last Modified On: |
16/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Open labeled non-interference Phase IV study of BBIL’s Typbar-
TCV with measles vaccine |
|
Scientific Title of Study
|
A Phase IV, Randomized, factorial assigned, Open labelled, study to evaluate
the non- interference in immune response of Typhoid Vi Capsular Polysaccharide - Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles vaccine given concomitantly |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/TCV/IV/2013:Version 1.0; Dated 26/08/2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B N Patnaik |
| Designation |
Associate Medical Director |
| Affiliation |
Bharat Biotech International Ltd |
| Address |
Genome Valley, Shameerpet
Hyderabad ANDHRA PRADESH 500078 India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
badri2299@bharatbiotech.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr B N Patnaik |
| Designation |
Associate Medical Director |
| Affiliation |
Bharat Biotech International Ltd |
| Address |
Genome Valley, Shameerpet
Hyderabad ANDHRA PRADESH 500078 India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
badri2299@bharatbiotech.com |
|
Details of Contact Person Public Query
|
| Name |
Dr B N Patnaik |
| Designation |
Associate Medical Director |
| Affiliation |
Bharat Biotech International Ltd |
| Address |
Genome Valley, Shameerpet
Hyderabad ANDHRA PRADESH 500078 India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
badri2299@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Ltd. |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Ltd |
| Address |
Genome Valley, Shameerpet, Hyderabad-500 078, Andhra Pradesh, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Krishana Murthy |
Cheluvamba Hospital |
Department Of Pediatrics Mysore Medical Collage & Research Institute, Irwin Road Mysore KARNATAKA |
09742620007
bkm6@rediffmail.com |
| Dr Vasant Khalatkar |
Colours Children Hospital |
Dr Vasant Khalatkar Colours Children Hospital R 29 Reshimbag Umrer road Nagpur 440009 Nagpur MAHARASHTRA |
9823044438 07122740500 vasant.khalatkar@gmail.com |
| DrMahantshetti |
Dr. Prabhakar Kore Hospital and Medical Research Centre |
Dr. Prabhakar Kore Hospital and Medical Research Centre Nehru Nagar Belgaum 590010 Belgaum KARNATAKA |
0831-2473777 08312471350 niranjanasn@yahoo.com |
| Dr Monjori Mitra |
Institute of Child Health |
Room No: 111
Department: OPD
Pediatric Division:
Institute of Child Health, 11Dr.Biresh Guha Street Kolkata WEST BENGAL |
03322908656 03322908656 monjorimr@gmail.com |
| Dr P Venugopal |
King George Hospital |
Department of pediatrics, Ist Floor, King George Hospital Visakhapatnam ANDHRA PRADESH |
9848027203
venugopal_kgh@yahoo.com |
| Dr Sandeep Mogre |
Mogre Hospital |
Dr. Sandeep Mogre Mogre Children Hospital 228 Tajshree Govind Apartment Sakkardara Square Umrer Road Nagpur-440009 Nagpur MAHARASHTRA |
07122741827
mogrehospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee KLE University |
Approved |
| Ethics committee, Mysore Medical Collage Research Center , Mysore |
Approved |
| Institute of Child Health, Kolkata |
Approved |
| Institutional Ethics committee, King George Hospital, Vishakapatnam |
Approved |
| Jasleen hospitals Ethics committee, Nagpur |
Approved |
| Jasleen hospitals Ethics committee, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
prevention of salmonalla typhi infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
M-VAC |
Group 4
M-VAC on day 0 |
| Intervention |
M-VAC and Typbar-TCV |
Group 2 : M-VAC on Day 0 and Typbar-TCV on day 28 |
| Intervention |
M-VAC co administration with Typbar-TCV |
Group 1A :
Typbar-TCV and M-VAC concomitantly on Day 0 and 2nd dose of Typbar-TCV on day 28 |
| Intervention |
M-VAC co administration with Typbar-TCV |
Group 1B : Typbar-TCV and M-VAC concomitantly on Day 0 and and 2nd dose of Typbar-TCV on day 180 |
| Intervention |
Typbar-TCV and M-VAC |
Group 3
Typbar-TCV on Day 0 and M-VAC on day 28 |
|
|
Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
10.00 Month(s) |
| Gender |
Both |
| Details |
1.Parents or Legally Acceptable Representative willing to give signed Informed Consent.
2. Infants aged 8 to 10 months.
3. Subjects should be available for the next 2 years for followup.
4. Subject, who has not received Measles vaccine or Typhoid vaccine.
5. Subjects are not currently participating in any other clinical trial or are in receipt of any other Investigational product in the last 06 months |
|
| ExclusionCriteria |
| Details |
1.Presence of any illness requiring hospital referral on the day
of Vaccine administration, temporary exclusion.
2. Known immunodeficiency.
3. Receipt of Blood products in the last 06 months.
4.Known case of HIV or other major Immunological
abnormalities.
5. In receipt of Systemic Immunosuppressant or systemic cortico-steroids.
6. Any household contact on Immunosuppressant.
7. Known allergy to any component of the Vaccine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the
immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B)
2.To determine the effect (anti-Vi antibodies) of booster dose
administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3) |
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the
immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B)
2.To determine the effect (anti-Vi antibodies) of booster dose
administration with TCV vaccine at day 28±2 (Group 1A) and at day 180±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GMTs of serum Vi antibodies and proportion that seroconvert
(four fold rise in titres to serum Vi antibodies) |
To measure the GMTs and seroconversion at day 0,day 28±2, day 56±7,180±15,360±30 and 720±30
safety for 2 years |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2014 |
| 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="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
|
Typhoid
fever continues to be important causes of illness and death, particularly among
children and adolescents in south-central and Southeast
Asia, where enteric fever is associated with poor sanitation and
unsafe food and water. High-quality incidence data from Asia
are underpinning efforts to expand access to typhoid vaccines. Efforts are
underway to develop vaccines that are immunogenic in infants after a single
dose and that can be produced locally in countries of endemicity. Antimicrobial
resistance has sequentially emerged to traditional first-line drugs, fluoroquinolones,
and third-generation cephalosporins, posing patient treatment challenges. The Vi
conjugate typhoid vaccine, Typbar-TCV under clinical trial have been found to
be highly immunogenic in infants and children less than 2 years of age in which
unconjugated Vi polysaccharide typhoid vaccine is known to induce very low or
nil immunogenic response.
Early
Immunizations not only prevent mortality and morbidity but also reduce the expenditure
of public and private resources. Introduction of Typhoid vaccine with measles vaccine
at 9 months of age in routine EPI programs will not substantially interfere with
measles elimination programs and will eliminate the need of an additional
typhoid vaccination visit in the already clustered initial EPI Immunization
visits. The current study proposed to evaluate immunogenicity and safety when
co-administered with measles vaccine. The objective
is to determine whether TCV can be successfully co-administered with Measles
without interfering with the immune response to each of these antigens.
This open
labeled, randomized, parallel study to evaluate the non- interference in immune
response of one dose of Typhoid Vi Capsular Polysaccharide-Tetanus Toxoid
Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles
vaccine given concomitantly.
The
subjects will be screened for eligibility in to the study after obtaining
written informed consent from the subject. Screening period might last for 7
days. Screening includes obtaining medical history, physical examination,
demographic details (weight, height & gender), Vital signs (Heart rate,
respiratory rate, body temperature-oral or axillary) and clinical evaluations.
After
completion of the screening process, the eligible, subjects shall be enrolled
into the study groups. Subjects shall be observed for 30 minutes after
vaccination, and for the next 7 days, recorded in the subject diary cards.
|