Please select the outcome measures that correspond to the clinical trial below.
Title: An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Brief Summary: The purpose of this study is to assess the safety and reactogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.


Options:
A: 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)
B: Grades of study product-related solicited adverse events (AEs) (Measured through Day 28); Grades of study product-related unsolicited AEs (Measured through Day 28); Grades of study product-related serious adverse events (SAEs) (Measured through Day 56); Number of participants with infection with vaccine virus (Measured through Day 56); Peak titer of vaccine virus shed (Measured through Day 28); Duration of vaccine virus shedding in nasal washes measured by culture (Measured through Day 28); Duration of vaccine virus shedding in nasal washes measured by RT-PCR (Measured through Day 28); Frequency of a greater than or equal to 4-fold rise in RSV-neutralizing antibody titer (Measured through Day 56); Antibody responses to RSV F glycoprotein as assessed by enzyme-linked immunosorbent assay (ELISA) (Measured through Day 56)
C: 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))
D: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)

Answer: C