Healthy Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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