Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5) (NCT NCT05526716)

Last Updated: 2025-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1080 participants

Primary outcome timeframe

Up to 5 days post-vaccination

Results posted on

2025-10-29

Participant Flow

This study was conducted at 56 centers in the United States.

Participant milestones

Participant milestones
Measure	Concomitant Group (V116 + QIV Followed by Placebo) Participants received a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of quadrivalent influenza vaccine (QIV) on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Overall Study STARTED	540	540
Overall Study Vaccinated at Visit 1	0	535
Overall Study Vaccinated at Visit 3	0	518
Overall Study COMPLETED	510	507
Overall Study NOT COMPLETED	30	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Concomitant Group (V116 + QIV Followed by Placebo) Participants received a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of quadrivalent influenza vaccine (QIV) on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Overall Study Death	1	2
Overall Study Lost to Follow-up	17	15
Overall Study Physician Decision	0	1
Overall Study Randomized by mistake without study treatment	0	1
Overall Study Withdrawal by Subject	12	12
Overall Study Not reported	0	2

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.	Total n=1072 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 8.4 • n=5 Participants	64.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	64.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	297 Participants n=5 Participants	287 Participants n=7 Participants	584 Participants n=5 Participants
Sex: Female, Male Male	239 Participants n=5 Participants	249 Participants n=7 Participants	488 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	127 Participants n=5 Participants	125 Participants n=7 Participants	252 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	403 Participants n=5 Participants	409 Participants n=7 Participants	812 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	107 Participants n=5 Participants	101 Participants n=7 Participants	208 Participants n=5 Participants
Race (NIH/OMB) White	410 Participants n=5 Participants	412 Participants n=7 Participants	822 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

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

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=534 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=535 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Number of Participants With Solicited Injection-site Adverse Events (AEs)	317 Participants	314 Participants

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

Population: 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.

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=534 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=535 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Number of Participants With Solicited Systemic AEs	219 Participants	224 Participants

PRIMARY outcome

Timeframe: Up to ~6 months postvaccination with V116

Population: 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.

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=534 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=535 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)

Population: 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.

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.

Outcome measures

PRIMARY outcome

Timeframe: Day 30

Population: 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.

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

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) A/H1N1	268.23 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	325.06 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) A/H3N2	128.07 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	163.06 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) B/Victoria	70.02 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	85.66 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) B/Yamagata	31.80 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	35.86 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.

SECONDARY outcome

Timeframe: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)

Population: 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.

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

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 15C	25.0 Ratio Interval 20.5 to 30.4	30.2 Ratio Interval 24.5 to 37.3
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 16F	9.9 Ratio Interval 8.6 to 11.4	11.9 Ratio Interval 10.3 to 13.7
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 3	5.2 Ratio Interval 4.6 to 5.9	6.7 Ratio Interval 5.9 to 7.6
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 6A	9.4 Ratio Interval 8.0 to 11.1	13.2 Ratio Interval 11.0 to 15.8
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 7F	8.1 Ratio Interval 6.8 to 9.6	9.8 Ratio Interval 8.1 to 11.9
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 8	9.6 Ratio Interval 8.0 to 11.6	10.9 Ratio Interval 9.0 to 13.3
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 9N	6.2 Ratio Interval 5.3 to 7.4	8.2 Ratio Interval 6.9 to 9.6
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 10A	10.4 Ratio Interval 8.7 to 12.6	11.1 Ratio Interval 9.2 to 13.4
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 11A	13.0 Ratio Interval 10.7 to 15.9	15.2 Ratio Interval 12.4 to 18.7
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 12F	37.4 Ratio Interval 30.8 to 45.5	46.8 Ratio Interval 37.7 to 58.0
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 15A	7.6 Ratio Interval 6.4 to 9.1	8.9 Ratio Interval 7.3 to 11.0
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 17F	10.4 Ratio Interval 8.8 to 12.4	15.1 Ratio Interval 12.8 to 18.0
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 19A	3.6 Ratio Interval 3.2 to 4.2	5.2 Ratio Interval 4.5 to 6.1
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 20A	6.7 Ratio Interval 5.7 to 7.7	8.5 Ratio Interval 7.3 to 9.9
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 22F	13.7 Ratio Interval 11.2 to 16.8	16.9 Ratio Interval 13.6 to 20.9
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 23A	17.0 Ratio Interval 14.0 to 20.8	25.5 Ratio Interval 20.4 to 31.8
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 23B	42.9 Ratio Interval 35.4 to 52.0	60.9 Ratio Interval 48.9 to 75.9
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 24F	31.6 Ratio Interval 26.1 to 38.3	33.2 Ratio Interval 27.3 to 40.5
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 31	29.8 Ratio Interval 24.5 to 36.2	40.3 Ratio Interval 32.5 to 49.9
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 33F	5.5 Ratio Interval 4.7 to 6.4	6.3 Ratio Interval 5.3 to 7.4
Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA 35B	5.5 Ratio Interval 4.7 to 6.4	6.3 Ratio Interval 5.3 to 7.4

SECONDARY outcome

Timeframe: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

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

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
GMFR Ratio of Serotype-specific IgG 3	3.6 Ratio Interval 3.3 to 4.0	4.1 Ratio Interval 3.7 to 4.6
GMFR Ratio of Serotype-specific IgG 6A	7.8 Ratio Interval 6.9 to 8.9	8.4 Ratio Interval 7.3 to 9.7
GMFR Ratio of Serotype-specific IgG 7F	5.6 Ratio Interval 5.0 to 6.4	7.2 Ratio Interval 6.3 to 8.2
GMFR Ratio of Serotype-specific IgG 8	7.1 Ratio Interval 6.2 to 8.1	8.7 Ratio Interval 7.5 to 10.1
GMFR Ratio of Serotype-specific IgG 9N	8.0 Ratio Interval 6.9 to 9.2	9.0 Ratio Interval 7.8 to 10.5
GMFR Ratio of Serotype-specific IgG 10A	9.3 Ratio Interval 8.1 to 10.6	11.4 Ratio Interval 9.9 to 13.1
GMFR Ratio of Serotype-specific IgG 11A	5.7 Ratio Interval 5.1 to 6.4	7.2 Ratio Interval 6.3 to 8.1
GMFR Ratio of Serotype-specific IgG 12F	6.9 Ratio Interval 6.0 to 8.0	7.9 Ratio Interval 6.8 to 9.1
GMFR Ratio of Serotype-specific IgG 15A	14.2 Ratio Interval 12.3 to 16.4	19.5 Ratio Interval 16.8 to 22.5
GMFR Ratio of Serotype-specific IgG 15C	11.0 Ratio Interval 9.6 to 12.6	12.3 Ratio Interval 10.6 to 14.2
GMFR Ratio of Serotype-specific IgG 16F	11.1 Ratio Interval 9.8 to 12.6	13.4 Ratio Interval 11.8 to 15.2
GMFR Ratio of Serotype-specific IgG 17F	10.9 Ratio Interval 9.5 to 12.5	13.2 Ratio Interval 11.5 to 15.3
GMFR Ratio of Serotype-specific IgG 19A	3.0 Ratio Interval 2.7 to 3.4	3.9 Ratio Interval 3.5 to 4.5
GMFR Ratio of Serotype-specific IgG 20A	7.4 Ratio Interval 6.5 to 8.4	8.9 Ratio Interval 7.7 to 10.2
GMFR Ratio of Serotype-specific IgG 22F	8.2 Ratio Interval 7.1 to 9.4	9.0 Ratio Interval 7.8 to 10.3
GMFR Ratio of Serotype-specific IgG 23A	15.5 Ratio Interval 13.6 to 17.6	17.3 Ratio Interval 15.0 to 20.0
GMFR Ratio of Serotype-specific IgG 23B	10.2 Ratio Interval 8.9 to 11.6	10.9 Ratio Interval 9.4 to 12.6
GMFR Ratio of Serotype-specific IgG 24F	20.2 Ratio Interval 17.4 to 23.4	23.5 Ratio Interval 20.3 to 27.3
GMFR Ratio of Serotype-specific IgG 31	12.6 Ratio Interval 11.2 to 14.2	15.3 Ratio Interval 13.5 to 17.3
GMFR Ratio of Serotype-specific IgG 33F	5.1 Ratio Interval 4.5 to 5.7	6.2 Ratio Interval 5.4 to 7.1
GMFR Ratio of Serotype-specific IgG 35B	12.3 Ratio Interval 10.9 to 13.9	14.9 Ratio Interval 13.0 to 17.1

SECONDARY outcome

Timeframe: Day 1 (Baseline) and Day 30 (Postvaccination)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=484 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=482 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
GMFR in Influenza Strain-specific HAI A/H1N1	4.5 Ratio Interval 3.9 to 5.2	5.7 Ratio Interval 4.9 to 6.7
GMFR in Influenza Strain-specific HAI A/H3N2	5.6 Ratio Interval 5.0 to 6.3	7.1 Ratio Interval 6.3 to 8.1
GMFR in Influenza Strain-specific HAI B/Victoria	3.6 Ratio Interval 3.3 to 4.0	4.5 Ratio Interval 4.0 to 5.1
GMFR in Influenza Strain-specific HAI B/Yamagata	1.9 Ratio Interval 1.8 to 2.1	2.2 Ratio Interval 2.1 to 2.4

SECONDARY outcome

Timeframe: Day 30

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

Outcome measures

Outcome measures
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=484 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=482 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 A/H1N1	47.1 Percentage of Participants Interval 42.6 to 51.7	55.6 Percentage of Participants Interval 51.0 to 60.1
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 A/H3N2	63.8 Percentage of Participants Interval 59.4 to 68.1	68.3 Percentage of Participants Interval 63.9 to 72.4
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 B/Victoria	52.3 Percentage of Participants Interval 47.7 to 56.8	54.1 Percentage of Participants Interval 49.6 to 58.7
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 B/Yamagata	23.3 Percentage of Participants Interval 19.6 to 27.4	29.9 Percentage of Participants Interval 25.8 to 34.2

Adverse Events

Concomitant Group (V116 + QIV Followed by Placebo)

Serious events: 10 serious events

Other events: 362 other events

Deaths: 1 deaths

Sequential Group (Placebo + QIV Followed by V116)

Serious events: 17 serious events

Other events: 348 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=534 participants at risk Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=535 participants at risk Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
General disorders Fatigue	30.3% 162/534 • Number of events 191 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	32.7% 175/535 • Number of events 218 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
General disorders Injection site erythema	11.8% 63/534 • Number of events 75 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	11.2% 60/535 • Number of events 68 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
General disorders Injection site pain	58.1% 310/534 • Number of events 481 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	56.6% 303/535 • Number of events 465 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
General disorders Injection site swelling	12.7% 68/534 • Number of events 83 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	12.3% 66/535 • Number of events 74 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Musculoskeletal and connective tissue disorders Myalgia	13.9% 74/534 • Number of events 79 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	15.0% 80/535 • Number of events 86 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Nervous system disorders Headache	20.4% 109/534 • Number of events 128 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	22.4% 120/535 • Number of events 142 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 7F	2399.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	3275.4 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 10A	3033.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	3966.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 12F	1869.9 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2449.5 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 15A	4670.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	6559.7 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 19A	1830.1 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2453.3 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 20A	5172.8 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	6986.9 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 23A	3358.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4319.9 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 3	209.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	250.1 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 6A	2056.4 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2608.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 8	1508.9 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2135.7 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 9N	5075.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	7566.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 11A	2576.3 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4051.1 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 15C	3426.0 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4832.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 16F	5371.5 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	7757.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 17F	5783.8 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	7924.3 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 22F	3194.9 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4158.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 23B	934.3 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	1664.5 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 24F	2996.5 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4143.1 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 31	2997.4 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4390.6 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 33F	9032.5 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	10765.1 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses 35B	7701.4 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.	9940.2 Titers Per protocol, within group CIs, or any other measures of dispersion, were not determined.

Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=536 Participants Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=536 Participants Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 3	0.60 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.66 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 24F	5.72 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	6.71 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 31	2.50 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2.96 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 6A	3.34 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	3.58 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 7F	3.91 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.01 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 8	6.84 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	8.38 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 9N	4.99 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.64 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 10A	8.45 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	10.70 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 11A	4.83 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.84 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 12F	1.10 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	1.31 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 15A	8.83 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	11.77 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 15C	7.13 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	8.39 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 16F	1.93 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	2.32 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 17F	9.69 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	11.44 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 19A	6.41 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	7.91 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 20A	13.57 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	16.52 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 22F	3.13 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	3.34 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 23A	3.30 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	3.87 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 23B	4.24 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	4.94 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 33F	9.09 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	11.26 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 35B	15.73 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.	18.57 µg/mL Per protocol, within group CIs, or any other measures of dispersion, were not determined.

Measure	Concomitant Group (V116 + QIV Followed by Placebo) n=534 participants at risk Participants received a single 0.5 mL IM injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30.	Sequential Group (Placebo + QIV Followed by V116) n=535 participants at risk Participants received a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30.
Blood and lymphatic system disorders Blood loss anaemia	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Cardiac disorders Atrial fibrillation	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Cardiac disorders Cardiac failure congestive	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Eye disorders Retinal detachment	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Gastrointestinal disorders Pancreatitis	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Gastrointestinal disorders Small intestinal ulcer haemorrhage	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
General disorders Chest pain	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Complicated appendicitis	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Diverticulitis	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Douglas' abscess	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Influenza	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Pneumonia	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Sepsis	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Septic shock	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Urosepsis	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Infections and infestations Wound infection	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Injury, poisoning and procedural complications Ankle fracture	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Injury, poisoning and procedural complications Scrotal injury	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Metabolism and nutrition disorders Hypokalaemia	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Metabolism and nutrition disorders Hyponatraemia	0.19% 1/534 • Number of events 2 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Musculoskeletal and connective tissue disorders Muscle spasms	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign fallopian tube neoplasm	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Nervous system disorders Haemorrhage intracranial	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 2/534 • Number of events 2 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Social circumstances Victim of homicide	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Vascular disorders Orthostatic hypotension	0.00% 0/534 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.19% 1/535 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.
Vascular disorders Peripheral ischaemia	0.19% 1/534 • Number of events 1 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.	0.00% 0/535 • Up to ~6 months postvaccination with V116 All-cause mortality is assessed in all randomized participants. Adverse events (AEs) and serious adverse events (SAEs) are reported for all participants as treated.