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Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine

NCT03527355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2021-08-27

No results posted yet for this study

Summary

This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.

The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.

The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.

Conditions

  • Typhoid

Interventions

BIOLOGICAL

Vi-DT

Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial

BIOLOGICAL

FluQuadri™

Manufacturer: Sanofi Pasteur Dose: 0.25 ml \*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.

OTHER

0.9% sodium chloride isotonic solution

Manufacture: Euro-Med Inc. Dose: 0.5 mL

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Maria Rosario Capeding, MD · Research Institute for Tropical Medicine, Metro Manila, Philippines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2018-07-28
Completion
2021-01-19

Countries

  • Philippines

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 NCT03527355 on ClinicalTrials.gov