Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
Brief Summary: The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially.

Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points.


Options:
A: 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)
B: Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event (7 days post each dose / 57 days post prime)
C: Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the first product administration (Day 7)); Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the second product administration (Day 91)); Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the first product administration (Day 7)); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after the second product administration (Day 91)); Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant (7 days after each product administration); Number of Subjects With Abnormal Laboratory Measures of Safety (Day 0 through Day 308); Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) (Day 0 through Day 28 after product administration); Number of Subjects With Serious Adverse Events (SAEs) (Day 0 through Day 308); Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration (Day 0 through Day 308)
D: 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)

Answer: B