Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
NCT ID:
NCT02075203
Group ID:
EG000
Title:
AERAS-404 (15 mcgH4/500 Nmol IC31)
Description:
2 doses on Study Days 0 and 56
AERAS-404: The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK \& a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 \& saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
330
Other Number Affected:
118
Other Number At Risk:
330
Study:
NCT02075203
Results Section:
NCT02075203
Adverse Events Module:
NCT02075203