Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.


Options:
A: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
B: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
C: Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to the Vaccine. (Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study))
D: Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers (At Day 57); Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers (At Day 57); Number of Subjects With Any Solicited Local Symptoms (Within 30 minutes after each vaccination); Number of Subjects With Any Solicited Local Symptoms (From Day 1 (6 hour) through Day 3 after each vaccination); Number of Subjects With Any Solicited Local Symptoms (From Day 4 through Day 7 after each vaccination); Number of Subjects With Any Solicited Local Symptoms (From Day 1 (6 hours) to Day 7 after each vaccination); Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity (Within 30 minutes after each vaccination); Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity (From Day 1 (6 hours) through Day 3 after each vaccination); Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity (From Day 4 through Day 7 after each vaccination); Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity (From Day 1 (6 hours) to Day 7 after each vaccination); Number of Subjects With Unsolicited Adverse Events (AEs) (From Day 1 to Day 28 after each vaccination); Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s) (From study start (Day 1) until study completion (Day 394))

Answer: D