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 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 2:09 PM
NCT ID:
NCT04645966
Group ID:
EG004
Title:
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)
Description:
Infant participants aged 2 months were administered a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh at Day 1 (primary vaccination 1) and Month 2 (primary vaccination 2). PLP was administered orally with 3 required doses, the first dose starting 30 minutes before vaccination at Day 1 and Month 2. Participants received a single intramuscular injection of 0.5 mL of bivalent rLP2086 (120 mcg) into the left thigh and 0.5 mL of Nimenrix into the right thigh approximately 10 months after vaccination 1 (booster vaccination). All participants received a single intramuscular injection of Prevenar 13 and Vaxelis into the right thigh at 2 and 4 months of age.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
53
Other Number Affected:
53
Other Number At Risk:
53
Study:
NCT04645966
Results Section:
NCT04645966
Adverse Events Module:
NCT04645966