Please select the outcome measures that correspond to the clinical trial below.
Title: Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"
Brief Summary: The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.


Options:
A: Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28); Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28); Frequency of vaccine-related lower respiratory illness (Measured through Day 56); Proportion of participants that develop 4-fold or greater rises in RSV-neutralizing antibody titer following vaccination (Measured through Day 56)
B: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) (Measured through Day 28); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through study follow-up period, up to 1 year after study entry)
C: Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination. (Day 0 to Day D+180); Counts and percentage of subjects with unsolicited (local and systemic) adverse events (AE), unscheduled medically-attended adverse events (MAEs), and serious adverse events (SAEs) through delivery and six (6) months thereafter. (Day 0 to Day D+180); Clinical safety laboratory assessments of select serum chemistry and hematology parameters through delivery. (Screening to Day 14); Counts and percentage of subjects with post-immunization onset of specific complications of third-trimester pregnancy and delivery (Day 0 to Day 28 - 42); Counts and percentage of term healthy infants appropriate for gestational age. (Day 28 - 42); Neonatal SAEs (including congenital anomalies, respiratory failure, fever/infection, and neonatal death or other adverse events/complications that necessitate extended hospitalization). (Birth to Day 365); Growth and development over one year (Birth to Day Day 365); Counts and proportion of infants with unsolicited adverse events (Birth to Day 365); Counts and proportions of infants with medically-attended RSV lower respiratory tract infection (LRTI), and age of onset of those infections. (Birth to Day 365)
D: 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)

Answer: D