Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age
Brief Summary: This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.


Options:
A: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain (Day 21 (post-vaccination))
B: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (Up to Day 187 (7 days after injection/each injection)); Number of Participants with Unsolicited Adverse Events (AEs) (Up to Day 208 (28 days after dose/each dose)); Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) (Up to Day 751); Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19 (Day 57); Geometric Mean (GM) Value of the Serum Ab Level (Day 57); Seroresponse Rate (SRR) of Vaccine Recipients (Day 57); Number of Participants with AEs Leading to Discontinuation From Study Post BD (Up to Day 751); GM Value of the Serum Ab Level Against Ancestral Strain Post BD (BD-Day 29); SRR of Vaccine Recipients Against Ancestral Strain Post BD at BD-Day 29 (BD-Day 29); GM Value of the Serum Ab Level Against Ancestral Strain Post Dose 2 (Day 57); SRR of Vaccine Recipients Against Ancestral Strain Post Dose 2 (Day 57); Number of Participants with AEs Leading to Discontinuation from Study from Dose 1 (Up to Day 361); GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against SARS-CoV-2 Omicron Variant (Day 29); GM Value of the Serum Ab Level After mRNA-1273.222 Vaccine Administration Against Ancestral Strain (Day 29)
C: Adverse reactions/events rate (7 days after vaccination); Adverse reactions/events rate (28 days after vaccination); Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) (14 days after the second vaccination); Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) (28 days after the second vaccination); Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) (14 days after the second vaccination); Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) (28 days after the second vaccination)
D: Participants with Solicited Adverse Events (AEs) - Phase 1 (28 days); Safety Laboratory Values (Serum Chemistry, Hematology) - Phase 1 (28 days); Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) - Phase 1 (21 days); Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) - Phase 1 (35 days); Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) - Phase 1 (35 days); Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) - Phase 1 (35 days); Serum IgG Antibody Levels Expressed as GMEUs - Phase 2 (Day 35); Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 (Day 35); Serum IgG Antibody Levels Expressed as SCRs - Phase 2 (Day 35); Participants with Solicited Adverse Events (AEs) - Phase 2 (28 days); Participants with Unsolicited AEs - Phase 2 (35 days)

Answer: A