An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling.

All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.

All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.

A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.

All randomized participants who received at least 1 dose of study vaccination and received QIV are included, according to actual vaccination received.

OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.

All randomized participants without deviations from the protocol that may substantially affect immunogenicity. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.

GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.

All randomized participants without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.

The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay.

All randomized participants without protocol deviations that may substantially affect the results of theimmunogenicity endpoint are included. Overall participants analyzed were the number of participantsrandomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available forthe respective serotype.

OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

All randomized participants without protocol deviations that may substantially affect the results of the immunogenicity endpoint and have all data available are included. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.

GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL.

All randomized participants without protocol deviations that may substantially affect the results of the immunogenicity endpoint and have all data available are included. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of those overall participants analyzed without protocol deviation and with data available for the respective serotype.

Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

All randomized participants without deviations from the protocol that may substantially affect immunogenicity, and who have both baseline and Day 30 data, are included. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.

The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay.

All randomized participants without deviations from the protocol that may substantially affect immunogenicity, and who have both baseline and Day 30 data, are included. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.