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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine

Clinicaltrials.gov identifier NCT03933098

Recruitment Status Active, not recruiting

First Posted May 1, 2019

Last update posted April 22, 2020

Study Description

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.

  • Condition or Disease:Typhoid
  • Intervention/Treatment: Biological: Test Vaccine Vi-DT Typhoid conjugate
    Biological: Control Vaccine Typbar TCV®
  • Phase: Phase 3
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 1800 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Participants age 6 months to 45 years
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • 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.
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Test group A: Lot 1 Vi-DT (typhoid conjugate vaccine)
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.
Biological: Test Vaccine Vi-DT Typhoid conjugate
Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Experimental: Test group B: Lot 2 Vi-DT (typhoid conjugate vaccine)
One dose of Vi-DT (typhoid conjugate vaccine) Lot 2 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months.
Biological: Test Vaccine Vi-DT Typhoid conjugate
Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Experimental: Test group C: Lot 3 Vi-DT (typhoid conjugate vaccine)
One dose of Vi-DT (typhoid conjugate vaccine) Lot 3 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months.
Biological: Test Vaccine Vi-DT Typhoid conjugate
Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Active Comparator: Test group D: Typbar TCV
One dose of Typbar TCV will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months.
Biological: Control Vaccine Typbar TCV®
Manufacturer: Bharat Biotech Ingredient: Purified Vi capsular polysaccharide of Salmonella Ty2 conjugated to tetanus toxoid protein Dose: 0.5 ml
Outcome Measures
  • Primary Outcome Measures: 1. Seroconversion rate1 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0) ]
    Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
  • 2. Geometric Mean Titers (GMT)1 [ Time Frame: 4 weeks after vaccination of Vi-DT ]
    Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT
  • Secondary Outcome Measures: 1. Geometric Mean Titers (GMT) 2 [ Time Frame: 4 weeks and 24 weeks after vaccination of Vi-DT(pooled)/ Typbar TCV® ]
    Measurement of the Geometric Mean Titers (GMT) following 4 weeks (28 days) and 24 weeks(168 days) after vaccination of Vi-DT (pooled)/ Typbar TCV®
  • 2. Seroconversion rate 2 [ Time Frame: 24 weeks (168 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0). ]
    Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
  • 3. Seroconversion rate 3 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled) ]
    Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers after vaccination of three lots of Vi-DT.
  • 4. Seroconversion rate 4 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled) ]
    Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers at 4 weeks (28 days) after vaccination of three lots of Vi-DT in each age strata
  • 5. Seroconversion rate 5 [ Time Frame: 4 weeks (28 days) after vaccination of MR compared to baseline (D0) ]
    Definded as IgG ELISA antibody titers for Measles (M), and Rubella (R) following single dose of MR a vaccine at baseline D0 and 4 weeks
  • 6. Safety endpoints for solicited adverse events (reactogenicity) [ Time Frame: 7days after vaccination of Vi-DT(pooled)/ Typbar TCV® ]
    Proportion of participants with local and systemic solicited adverse events
Eligibility Criteria
  • Ages Eligible for Study: 6 to 45 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

Nepal, City- Nepalgunj
Nepalgunj medical college
Banke

Nepal, Dharan
B.P.Koirala Institute of Health Sciences
Rautahat

Nepal, Dhulikhel
Dhulikhel Hospital
Kavre

Nepal, Sukedhara
Kanti Children's Hospital
Kathmandu

Sponsors and Collaborators

International Vaccine Institute

SK Bioscience Co., Ltd.

Investigators

Principal Investigator: Ganesh Kumar Rai, MD Kanti Children's Hospital

More Information
  • Responsible Party: International Vaccine Institute
  • ClinicalTrials.gov Identifier: NCT03933098 History of Changes
  • Other Study ID Numbers: IVI T003
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: April 22, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by International Vaccine Institute: Typhoid conjugate vaccine
    Vi-DT
    Safety
    Immunogenicity
  • Additional relevant MeSH terms: Typhoid Fever