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Designing an adaptive phase II/III trial to evaluate efficacy, safety and immune correlates of new TB vaccines in young adults and adolescents

Abstract:

This article summarises the consensus arrived at a meeting of South African and international stakeholders on specific late phase clinical trial design issues integrating the investigation of immune correlates as an integral part of a phase III protocol for a preventative TB vaccine in an adolescent/adult population. The challenge ahead is to optimize the planning for phase 3 TB vaccine preventative trials, under resource constraints, given that there are no known correlates of protection to ...

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Publisher copy:
10.1016/j.tube.2012.11.005

Authors


Rustomjee, R More by this author
McClain, B More by this author
Brennan, MJ More by this author
Chetty-Makkan, CM More by this author
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Journal:
Tuberculosis
Volume:
93
Issue:
2
Pages:
136-142
Publication date:
2013-03-05
DOI:
EISSN:
1873-281X
ISSN:
1472-9792
URN:
uuid:ee1fc461-a73e-45e7-b775-f353db130c44
Source identifiers:
394120
Local pid:
pubs:394120

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