CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,272 enrolled
Drug / intervention
BCGbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01906853
NCT01906853Phase 3Completed
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A Randomised, Controlled Trial to Determine if BCG Immunisation at Birth Reduces Allergy and Infection in Infants

Murdoch Childrens Research Institute·interventional·Posted Jul 24, 2013·Updated Feb 17, 2025

In Brief

A Phase 3 clinical trial evaluating BCG for Allergy and 2 related conditions. Completed, enrolled 1,272 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergy, Eczema, Respiratory Tract Infections
CountriesAustralia
CollaboratorsRoyal Children's Hospital, Mercy Hospital for Women, Australia, University of Melbourne

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 24, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2023
Study CompletionFeb 1, 2025
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 12.9 years ago

Interventions

BCGbiological