A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.

Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported.

Seroconversion was defined for each of the 4 influenza vaccine strains as 1) HI titer greater than or equal to (>=) 1:40 in participants with a pre-vaccination HI titer of less than (<) 1:10, or 2) a >=4-fold HI titer increase in participants with a pre-vaccination HI titer of >=1:10.

Seroprotection was defined for each of the 4 influenza vaccine strains as HI titer >=1:40 at 29 days after the administration of a HD quadrivalent seasonal influenza vaccine.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited local AEs were injection site pain or tenderness, erythema and swelling at the study vaccine injection site.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine and were pre-defined systemic events for which participants were to be specifically questioned and which were noted by participants in their participant diary for 14 days post vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs included fever (body temperature >=100.4 degree Fahrenheit), fatigue, headache, nausea, myalgia, and fever.

Percentage of participants with unsolicited AEs for 29 days after each vaccination was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccination.

Percentage of participants with SAEs from vaccination 1 to until 6 months after vaccination 2 was reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) and EPA as determined by multiplex ECL-based immunoassay were reported.

Opsonophagocytic antibody titers to vaccine O-serotype antigens O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 as determined by MOPA were reported.

Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by MOPA were reported.

Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.

Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by multiplex ECL-based immunoassay were reported.

Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.

Opsonophagocytic antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) in participants with and without history of UTI at enrollment as determined by MOPA were reported.