| CTRI Number |
CTRI/2019/10/021823 [Registered on: 30/10/2019] Trial Registered Prospectively |
| Last Modified On: |
29/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to evaluate the Immunogenicity and Safety of Typbar-TCV® in Adults |
|
Scientific Title of Study
|
A Phase IV Study to Evaluate the Immunogenicity and Safety of Purified Vi capsular polysaccharide (of Salmonella typhi, Ty2 strain) tetanus toxoid conjugate vaccine; Typbar-TCV® in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/TCV/IV-4/2019, version 1.0 dated 12 jul 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited Genome Valley
Shameerpet
Hyderabad
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited Genome Valley
Shameerpet
Hyderabad
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited Genome Valley
Shameerpet
Hyderabad
Hyderabad
TELANGANA
500078
India |
| Phone |
04023480567 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat Biotech International Limited |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Ltd |
| Address |
Bharat Biotech International Limited Genome Valley
Shameerpet hyderabad 500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Epari Venkata rao |
Institute of Medical Sciences and SUM hospital |
Kalinga Nagar
Ghatika
1st Floor
Annexure Building
Bhubaneswar
Khordha
ORISSA |
7853889552
e.venkata.rao@gmail.com |
| Dr Amit Suresh Bhate |
Jeevan Rekha Hospital |
DR B R Ambedkar Road
Opp Civil Hospital
Veer Chambers
Research department
3rd Floor
Room no 2
Belgavi
Bangalore
KARNATAKA |
9695237796
jrhclinicalresearch@gmail.com |
| Dr R Vasudev |
King George Hospital |
Department of Medicine, King George Hospital
Maharanipeta
Vizag 530002
Visakhapatnam
ANDHRA PRADESH |
9866739808
vasudev.kgh@gmail.com |
| Dr Jitendra Singh Kushwala |
Prakhar Hospital Pvt Ltd |
Consultant Physician, 8/219 Arya nagar kanpur
Uttarpradesh
Kanpur Nagar
UTTAR PRADESH |
09415040752
principalinvestigator1177@gmail.com |
| DrManish Multani |
Rahate Surgical Hospital & ICU |
Near telephone exchange square
517,Juni Mangalwari,Central avenue
Nagpur
MAHARASHTRA |
8983178550
mkmultani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of the Prakhar Hospital |
Approved |
| Ethics committee rahate surgical hospital |
Approved |
| Institutional Ethics Committee institutional Medical Sciences and SUM Hospital |
Approved |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee, KGH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Helthy subjects 1 to 65 years of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Typbar TCV |
Visit 1: (Day 0+3days)
Subjects between ages≥18 to ≤65 years will be screened as per the eligibilty criteria, after obtaining written informed consent. Screening procedures include: medical history, physical examination, demographic data (weight, height & gender), and vital signs (heart rate, respiratory rate& body temperature-oral). After completion of the screening processif determined to be eligible, subject shall be enrolled into the study. 5 mL of peripheral venous blood will be collected before vaccination for the baseline antibody titer estimation at Day 0 (Visit 1). One dose of 0.5ml of BBIL’s Typbar TCV® will be administered in the deltoid region of the arm. Subjects will be observed for 30 minutes after vaccine administration for vaccine reactogenicity. If no adverse event is observed subject is allowed to leave the site. A diary card will be issued to record any adverse event which will be brought for subsequent visits for review by the study physician. The diary card will contain information pertaining to the date of the next visit and a log for recording any adverse events. Subjects will be informed to contact the study physician for any immediate medical assistance. Also inform the subjects about the telephonic follow up by the site for solicited adverse event post vaccination for the next seven days.
Visit 2: (Day 28±2)
On day 28±2, the following activities will be recorded: current health status, physical examination, vital signs and body temperature. 5 mL of blood sample will be collected for immunogenicity testing. Dairy card will be collected and reviewed. Adverse events, if any will be documented in the source document.If the subject develops fever or is concerned about his/her health, they will be advised to visit the study site.
Follow-up (3 months)
Telephonic follow-up will be done once at the end of 3 months from the day of vaccination to record the adverse events.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of age ≥18 to ≤65years (inclusive) without significant medical history or abnormal clinical findings
Subject or Subject’s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent
Agree to be available for all study related visits and procedures throughout the entire duration of the study.
Female subject’s of child bearing potential must demonstrate a negative urine pregnancy test at the time of screening.
Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator
|
|
| ExclusionCriteria |
| Details |
Subjects with age less than 18 years and more than 65 years.
Fever of any origin or duration for more than 3 days prior to intended study immunization
Past history of Typhoid infection.
History of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
Individuals with any serious chronic or progressive diseases according to the judgment of Investigator (eg: neurological, neoplasm, insulin-dependent diabetes, hepatic, renal, cardiac diseases).
Any confirmed or suspected use of immunosuppressive drugs or Immuno deficient condition.
Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid.
Any criteria, which in the opinion of the investigator, suggests that the subject may not be compliant with the study protocol.
History of allergy or allergic reactions to the vaccine or any vaccine component.
Women who are pregnant or breast-feeding or of childbearing age.
Married or sexually active participants who are not willing to follow effective birth control methods for at least 3 months after vaccine.
Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of subjects attaining seroconversion ( four-fold rise in anti-salmonella typhi Vi polysaccharide IgG antibody titre compared to baseline), 28±2 days after vaccine administration
Compare GMT and Seroconversion at Day 0 and Day 28
|
Day 0 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse Events |
Day 0 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2019 |
| Date of Study Completion (India) |
30/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Open-labelled study to evaluate the
immunogenicity and safety of Typhoid Conjugate vaccine (Typbar TCV®) in adults within the age group of ≥18 to
≤65 years.
Visit 1:
(Day 0+3days)--Subjects between ages≥18 to ≤65 years will be screened as per the
eligibilty criteria, after obtaining written informed consent.5 mL of peripheral venous blood will be
collected before vaccination for the baseline antibody titer estimation at Day
0 (Visit 1). One dose of 0.5ml of BBIL’s Typbar TCV® will be
administered in the deltoid region of the arm. Subjects will be observed for 30
minutes after vaccine administration for vaccine reactogenicity. If no adverse
event is observed subject is allowed to leave the site.
Visit 2: (Day 28±2)
On
day 28±2, the following activities will be recorded: current health status,
physical examination, vital signs and body temperature. 5 mL of blood sample
will be collected for immunogenicity testing. Dairy card will be collected and
reviewed.
Telephonic follow-up will be done once at the
end of 3 months from the day of vaccination to record the adverse events. |