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Study of AERAS-402 in Healthy Infants

NCT01198366 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2017-05-08

Study results available
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Summary

AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.

Conditions

Interventions

BIOLOGICAL

AERAS-402 1.5 x 10^10 vp

BIOLOGICAL

AERAS-402 3.0 x 10^10 vp

BIOLOGICAL

AERAS-402 1.0 x 10^11 vp

BIOLOGICAL

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Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Aeras

    lead OTHER

Principal Investigators

  • Robert Walker · Aeras

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
112 Days
Max Age
182 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Kenya
  • Mozambique
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01198366 on ClinicalTrials.gov