Brief Title
Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine
Official Title
A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants.
Brief Summary
This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in
healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose.
The study objectives are:
I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion
rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity
of three lots of Vi-DT)
II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three
lots of Vi-DT vaccine 4 weeks after single dose.
Detailed Description
Subjects will be stratified according to age. The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical/medications history, physical
examination, Vital signs, Urine pregnancy test (UPT)
Visit 2 (day 0): Enroll, randomize and administer vaccine to eligible participants and assess
participant safety by physical examination and Vital signs, Collect blood for immunogenicity
assessments.
Visit 3 (day 7): Check solicited adverse reaction 7 days post vaccination and Assess
participant safety by physical examination and Vital signs
Visit 4 (day 28): Assess participant safety by physical examination and Vital signs, Collect
blood for immunogenicity assessments
Visit 5 (day 84): Assess participant safety by physical examination and Vital signs
Visit 6 (day 168): Assess participant safety by physical examination and Vital signs, Collect
blood for immunogenicity assessments, and fill in study completion form in the absence of any
safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two
distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine
administrator.
For retention: After vaccination, field health worker/designee will contact participant every
day till Day 7 by physical visit or by phone call. Follow-up reminder calls will be done very
frequently as per discretion of study staff until 24 weeks for all participant to assess
participant safety.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Seroconversion rate1
Secondary Outcome
Geometric Mean Titers (GMT) 2
Condition
Typhoid
Intervention
Test Vaccine Vi-DT Typhoid conjugate
Study Arms / Comparison Groups
Test group A: Lot 1 Vi-DT (typhoid conjugate vaccine)
Description: One dose of Vi-DT (typhoid conjugate vaccine) Lot 1 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1800
Start Date
November 15, 2019
Completion Date
January 2021
Primary Completion Date
September 2020
Eligibility Criteria
Inclusion Criteria:
1. Healthy participants 6 months to 45 years of age at enrollment
2. Participants/Parents/LAR who have voluntarily given informed consent/assent
3. Participants/Parents/LAR willing to follow the study procedures of the study and
available for the entire duration of the study
Exclusion Criteria:
1. Child with a congenital abnormality
2. Subject concomitantly enrolled or scheduled to be enrolled in another trial
3. Known history of immune function disorders including immunodeficiency diseases (Known
HIV infection or other immune function disorders)
4. Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for
periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
5. Receipt of blood or blood-derived products in the past 3 months
6. Subject with a previously ascertained or suspected disease caused by S. Typhi
7. Subject who have had household contact with/and or intimate exposure to an individual
with laboratory-confirmed S. Typhi
8. Individual who has previously received a typhoid vaccine
9. Subject who has received or is expected to receive other vaccines from 1 month prior
to IP vaccination to Visit 4 (approx.1 month post IP) except PVC booster as per EPI
schedule
10. Known history or allergy to vaccines or other medications
11. History of uncontrolled coagulopathy or blood disorders
12. Any abnormality or chronic disease which in the opinion of the investigator might be
detrimental for the safety of the subject and interfere with the assessment of the
study objectives
13. Any female participant who is lactating, pregnant* or planning for pregnancy during
the course of study period
14. Participants/Parents/LAR planning to move from the study area before the end of study
period
15. As per Investigator's medical judgement individuals could be excluded from the study
inspite of meeting all inclusion/exclusion criteria mentioned above
Temporary Contraindication
16. Acute illness, in particular infectious disease or fever (axillary temperature
≥37.5°C), within three days prior to enrolment and vaccination.
- Urine pregnancy test (UPT) will be performed in all married females prior to
injection
Gender
All
Ages
6 Months - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ganesh Kumar Rai, MD, ,
Location Countries
Nepal
Location Countries
Nepal
Administrative Informations
NCT ID
NCT03933098
Organization ID
IVI T003
Responsible Party
Sponsor
Study Sponsor
International Vaccine Institute
Collaborators
SK Bioscience Co., Ltd.
Study Sponsor
Ganesh Kumar Rai, MD, Principal Investigator, Kanti Children's Hospital
Verification Date
April 2020