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Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

NCT03299426 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30000

Last updated 2026-05-12

No results posted yet for this study

Summary

This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).

Conditions

  • Typhoid

Interventions

BIOLOGICAL

Vi-Typhoid Conjugate Vaccine (Vi-TCV)

Single 0.5-ml intramuscular injection

BIOLOGICAL

Meningococcal A Conjugate Vaccine (MCV-A)

Single intramuscular injection. Children 9-11 months will receive a 5µg/0.5ml dose. Children 12 months and older will receive a 10µg/0.5 ml dose.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of Malawi

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Matthew Laurens, MD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2025-01-30
Completion
2027-01-30

Countries

  • Malawi

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 NCT03299426 on ClinicalTrials.gov