Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

NCT00242047 | Unknown Phase 4

• 1 other identifier: UCT REC 271/2000
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis

Keywords

Tuberculosis.; Children.; Vaccine.; BCG.

Outcome Measures

Primary Outcomes (1)

• Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.

Secondary Outcomes (5)

• Comparison of Rate of Adverse Events.

• Comparison of Mortality Rates.

• Microbiological diagnosis of tuberculosis in a primary care setting.

• Rating of diagnostic scoring systems.

• Case definition of tuberculosis.

Interventions

Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). BIOLOGICAL

Eligibility Criteria

• Age: 0 Years - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be eligible to receive routine BCG vaccination.
• The child must be born at one of the five hospitals taking part in the study and be a resident in the study area.
• The mother must have had an opportunity to become informed about the study, either through pre-natal classes and a follow-up visit or, if time and the situation permits, after the mother presents at the hospital or birthing facility and before or after the child is born.
• After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form.

You may not qualify if:

• The mother fails to give informed consent.
• The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams).
• The infant is hospitalized outside of the study area before vaccination has been given (e.g. transferred to a hospital in Cape Town because of respiratory distress).

Sponsors & Collaborators

• University of Cape Town: lead
• Aeras: collaborator
• Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.: collaborator

Study Sites (1)

South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

• 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.

  PMID: 19008268 DERIVED

Related Links

• SATVI website

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Gregory Hussey, FCCH

  South African Tuberculosis Vaccine Initiative

  PRINCIPAL INVESTIGATOR

• Larry Geiter, PhD

  Aeras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 19, 2005
• Study Start: March 1, 2001
• Study Completion: August 1, 2006
• Last Updated: October 19, 2005

Record last verified: 2004-11

Locations

ZA (1)