Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial.

ABSTRACT:

Objective

To compare the incidence of tuberculosis over two years in infants vaccinated at birth with intradermal BCG or with percutaneous BCG.

Design

Randomised trial.

Setting

South Africa.

Participants

11,680 newborn infants.

Interventions

Infants were randomised by week of birth to receive Tokyo 172 BCG vaccine through the percutaneous route (n=5775) or intradermal route (n=5905) within 24 hours of birth and followed up for two years.

Main outcome measures

The primary outcome measure was documented Mycobacterium tuberculosis infection or radiological and clinical evidence of tuberculosis disease. Secondary outcome measures were rates of adverse events, all cause and tuberculosis specific admissions to hospital, and mortality.

Results

The

SUBMITTER: Hawkridge A 

PROVIDER: S-EPMC2583390 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature