Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

NCT00242047 ↗

Phase 4 Unknown 12000 enrolled University of Cape Town Aeras · collab Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan. · collab

RandomizedSingle-groupOpen-labelPrevention

Summary

An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.

Timeline

Start: 2001-03
Primary completion: —
Completion: 2006-08

Outcome

Met primary endpoint

paper Equivalence was found between intradermal BCG vaccine and percutaneous BCG in the incidence of tuberculosis PMID 19008268 ↗

Publications

Hawkridge A, Hatherill M, Little F, Goetz MA, Barker L, Mahomed H, Sadoff J, Hanekom W, Geiter L, Hussey G; South African BCG trial team. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ. 2008 Nov 13;337:a2052. doi: 10.1136/bmj.a2052.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).	Vaccine	—	Other