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Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants

NCT01861730 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2018-04-09

No results posted yet for this study

Summary

Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly in Bacille Calmette-Guerin (BCG) primed infants.

Conditions

Interventions

BIOLOGICAL

AERAS-404

AERAS-404 has two components: the H4 antigen and the IC31 adjuvant. The reconstitution of the vaccine components, H4 antigen (manufactured at SP) and IC31 adjuvant (supplied by SSI), will take place at the clinical research site (CRS) prior to injection.

BIOLOGICAL

Placebo

Tris buffered saline (10mM Tris, pH 7.4, 150nm sodium chloride).

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    collaborator NETWORK

  • Aeras

    lead OTHER

Principal Investigators

  • Ann Ginsberg, MD, PhD · Aeras

  • Avy Violari, MD · Perinatal HIV Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
64 Days
Max Age
196 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-01
Primary Completion
2017-12-22
Completion
2017-12-22

Countries

  • 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 NCT01861730 on ClinicalTrials.gov