CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Bioject ID Pen +1 moredevice
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/NCT01742364
NCT01742364N/ACompleted
CompareCT.gov

A Randomized Clinical Trial in Adults and Newborns to Compare the Safety, Reactogenicity and Immunogenicity of BCG Administration Via a Disposable Syringe Jet Injector (DSJI) to BCG Administration Via Syringe and Needle

PATH·interventional·Posted Dec 5, 2012·Updated Feb 8, 2017

In Brief

A clinical study evaluating Bioject ID Pen and Needle and syringe for Tuberculosis. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The study is designed to test the hypothesis that BCG administration via jet injector will produce a comparable immune response and that there will be no significant differences in safety or reactogenicity between BCG administration via jet injector and needle and syringe. The primary objectives of this study are to... 1. Compare the safety and reactogenicity of BCG administered intradermally by a jet injector device in adults and infants, to BCG administered intradermally by needle and syringe; 2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet injector device to infants vaccinated with BCG via needle and syringe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa
CollaboratorsWorld Health Organization, University of Cape Town

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2012
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.6 years ago

Interventions

Bioject ID Pendevice

Participants in this arm will receive a standard dose of BCG via the Bioject ID needle-free jet injector device (investigational administration technique).

Needle and syringedevice

Participants in this arm will receive a standard dose of BCG via syringe and needle by the Mantoux technique (standard of care administration technique).