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Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction

NCT01906853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1272

Last updated 2025-02-17

No results posted yet for this study

Summary

1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life.
2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.

Conditions

  • Allergy
  • Eczema
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

BCG

Sponsors & Collaborators

  • Royal Children's Hospital

    collaborator OTHER

  • Mercy Hospital for Women, Australia

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Prof Nigel Curtis, MBBS DCH DTM&H MRCP FRCPCH PhD · Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2023-09-30
Completion
2025-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01906853 on ClinicalTrials.gov