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

NCT03933098 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2020-04-22

No results posted yet for this study

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.

Conditions

  • Typhoid

Interventions

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

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

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Ganesh Kumar Rai, MD · Kanti Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2020-09-30
Completion
2021-01-31

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933098 on ClinicalTrials.gov