GLOW: mRNA-1010 influenza vaccine in older adults

• mRNA-1010

  Single dose of mRNA-1010 IM.

• Fluarix Quadrivalent

  Single dose of Fluarix Quadrivalent IM.

Primary

• Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)7 days post-vaccination

• Number of Participants With Unsolicited Adverse Events (AEs)Up to 28 days post-vaccination

• Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to DiscontinuationDay 1 through Day 361

• Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match14 days post-vaccination through Day 181

Secondary

• Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains With Similarity to Those Selected for the Seasonal Vaccine14 days post-vaccination through Day 181

• Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains Antigenically Matched to the Vaccine Strains14 days post-vaccination through Day 181

• Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains14 days post-vaccination through Day 181

• Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI14 days post-vaccination through Day 181

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29Day 29

• Percentage of Participants Reaching Seroconversion at Day 29Day 29

• Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29Day 29