Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.


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); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through Day 56); 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)
B: Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 7); Number of Subjects With Abnormal Biochemical Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 7); Number of Subjects With Abnormal Haematological Laboratory Values. (At Day 30); Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading (From Day 7 up to Day 30); Number of Subjects With Haematology Change From Baseline by Maximum Grade (From Day 7 up to Day 30); Number of Subjects With Solicited Local Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Solicited General Symptoms (During a 7-day follow-up period (from Day 0 to Day 6) after vaccination); Number of Subjects With Unsolicited Adverse Events (AEs) (During a 30-day follow-up period (from Day 0 to Day 29) after vaccination); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination (Day 0) up to study end (Day 30))
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: 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: C