Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT02748967
Brief Summary:
The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to \[\> =\] 20 years of age.
Detailed Description:
This is a Phase 1 double-blind (neither the Investigator nor the participant know the treatment), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) parallel group, single center study in healthy Japanese participants aged greater than or equal to \[\> =\] 20 years. A target of approximately 48 participants will be enrolled that are stratified according to their age in 2 groups: 24 participants \> = 20 to less than \[\<\] 50 years of age and 24 participants \> = 50 years of age. Both groups will be randomized to a single vaccination with 1 of the 3 study dose levels of ExPEC4V or placebo (vaccine buffer). Participants will be enrolled in a dose ascending approach. Blood samples will be drawn on Days 1 (prevaccination), 15 and 30 for the assessment of immunogenicity. The study duration per participant will be approximately 38 days (Screening period and postvaccination follow-up included). Participants' safety will be monitored throughout the study.
Study:
NCT02748967
Study Brief:
Protocol Section:
NCT02748967