Trial Outcomes & Findings for Gene Signatures of Influenza Vaccine Responses in Older Adults (NCT NCT03603509)

NCT ID: NCT03603509

Last Updated: 2023-05-16

Results Overview

Cytokine secretion (interferon alpha 2a) after in vitro stimulation with influenza virus

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

241 participants

Primary outcome timeframe

Baseline, Day 1

Results posted on

2023-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Fluad Vaccine Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Overall Study STARTED	120	121
Overall Study COMPLETED	117	117
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluad Vaccine Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Gene Signatures of Influenza Vaccine Responses in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluad Vaccine n=120 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=121 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.	Total n=241 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	119 Participants n=99 Participants	121 Participants n=107 Participants	240 Participants n=206 Participants
Age, Continuous	71.7 years n=99 Participants	71.4 years n=107 Participants	71.5 years n=206 Participants
Sex: Female, Male Female	78 Participants n=99 Participants	74 Participants n=107 Participants	152 Participants n=206 Participants
Sex: Female, Male Male	42 Participants n=99 Participants	47 Participants n=107 Participants	89 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=99 Participants	119 Participants n=107 Participants	237 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	120 participants n=99 Participants	121 participants n=107 Participants	241 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: The number of samples analyzed is less than the study cohort total because some of the serum samples failed in the assay. These failures were either: results did not meet QC, sample degraded and failed to function in the assay properly.

Cytokine secretion (interferon alpha 2a) after in vitro stimulation with influenza virus

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=106 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=112 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Innate Cell IFNa2a Production Day 0 Stimulated	112.3650 pg/mL Interval 67.6193 to 181.9535	131.4214 pg/mL Interval 87.0718 to 187.8301
Innate Cell IFNa2a Production Day 1 Stimulated	107.5846 pg/mL Interval 67.6607 to 189.9629	134.9071 pg/mL Interval 90.1967 to 196.628

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: The number of samples analyzed is less than the study cohort total because some of the serum samples failed in the HAI assay. These failures were either: results did not meet QC, sample degraded and failed to function in the assay properly.

Reciprocal of the serum dilution exhibiting no hemagglutination (the larger the number, the more agglutinating antibodies the subject has. A titer of equal to more than 1:40 and above is considered a protective antibody titer)

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=117 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=117 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Hemagglutination Inhibition Ab Titer Day 0	40 Titer Interval 20.0 to 60.0	40 Titer Interval 20.0 to 80.0
Hemagglutination Inhibition Ab Titer Day 8	40 Titer Interval 40.0 to 80.0	80 Titer Interval 40.0 to 160.0
Hemagglutination Inhibition Ab Titer Day 28	80 Titer Interval 40.0 to 160.0	80 Titer Interval 40.0 to 160.0

PRIMARY outcome

Timeframe: Baseline, Day 28

Gene expression counts. The number shown is the total number of RNA molecules whose sequence matches a human gene. This is a measure of how much gene expression is occurring in the cells in each subject's blood sample.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=109 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=110 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
T Cell Gene Expression Day 0	36019037 Total gene counts Interval 32656120.0 to 39665767.0	36566557 Total gene counts Interval 33316917.25 to 39356142.75
T Cell Gene Expression Day 28	34319023 Total gene counts Interval 31763324.0 to 38266331.0	35360483 Total gene counts Interval 33032560.5 to 39424114.25

PRIMARY outcome

Timeframe: Baseline, Day 8, Day 28

Population: Data was not collected or analyzed

Next generation sequencing of purified T cells' miRNA

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Day 8

IFNAR1 gene counts (the number of molecules of RNA whose sequence matches the interferon alpha receptor 1 gene that were present in the subject's blood sample).

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=109 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=110 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Innate IFNAR1 Cell Gene Expression Baseline	1516 Gene counts Interval 1263.0 to 1748.0	1572.5 Gene counts Interval 1275.5 to 1845.75
Innate IFNAR1 Cell Gene Expression Day 8	1450 Gene counts Interval 1201.0 to 1751.0	1562 Gene counts Interval 1327.25 to 1815.75

PRIMARY outcome

Timeframe: Baseline, Day 1, Day 8

Population: Data was not collected or analyzed

Next generation sequencing of purified innate cells' miRNA

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 28

Population: A subset of the total participants' samples were tested to determine the scientific value of this outcome. Based on pre-specified optimization analyses the assay results were highly variable and would not be informative, therefore the assay was not run on all participant samples. Results are reported for the participants' samples that were tested for optimization analyses.

Number of influenza-specific Ab producing memory B cells. Spot Forming Units (SFUs) are the frequency of Ab secreting B cells in an ELISPOT assay.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=6 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=6 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Memory B Cell ELISPOT	5.7 SFUs per 200,000 cells Interval 0.9 to 10.4	16.3 SFUs per 200,000 cells Interval 6.8 to 19.2

SECONDARY outcome

Timeframe: Day 28

influenza-specific, IFNg producing, memory T cells. Spot Forming Units (SFUs) are the frequency of IFN-g secreting T cells in an ELISPOT assay.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=4 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=4 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
T Cell ELISPOT Response	14.4 SFUs per 200,000 cells Interval 10.6 to 24.1	17.4 SFUs per 200,000 cells Interval 14.4 to 20.4

SECONDARY outcome

Timeframe: Day 28

Population: A subset of the total participants' samples were tested to determine the scientific value of this outcome. Based on pre-specified optimization analyses, it was determined that results did not capture vaccination-specific responses and would not be useful for the clinical trial, therefore the assay was not run on all participant samples. Results are reported for the participants' samples that were tested for optimization analyses.

Flow cytometry analysis of T cells. The results show the percentage of specific white blood cell types are present in each subject's blood sample. Reported as a % of the total peripheral blood mononuclear cells.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=5 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=4 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
T Cell Phenotype CD3+ T cells	44.31 Percentage Interval 39.88 to 47.76	42.5 Percentage Interval 38.22 to 46.22
T Cell Phenotype CD4+ T cells	18.41 Percentage Interval 17.49 to 20.49	17.98 Percentage Interval 15.55 to 21.71
T Cell Phenotype CD8+ T cells	8.73 Percentage Interval 6.02 to 9.92	10.28 Percentage Interval 7.55 to 12.03

SECONDARY outcome

Timeframe: Day 1 (stim)

Flow cytometry analysis of innate cells. The results show the percentage of classical monocytes in each subject's blood sample. The data are reported as a percentage of the peripheral blood mononuclear cells.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=3 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=3 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Innate Cell Phenotype	70.1 Percentage Interval 69.35 to 73.35	93.1 Percentage Interval 83.35 to 96.15

SECONDARY outcome

Timeframe: Baseline

Serum CMV-specific IgG level. Number reported as Sample Index (the optical density in an ELISA). The Sample Index is a semi-quantitative measure of how much CMV-specific IgG antibodies are in each subject's blood sample. The values range from 0 to 4. Values between 0 and 3 are relative measures of the amount of antibody (0 = no antibody, 1 = a low level of antibody, 3 = a high level of antibody). Values from 3-4 all reflect high levels of antibody but typically exceed the linear range of the assay and cannot be used to quantify exact amounts of antibody.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=117 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=117 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
CMV Serostatus	2.018 Sample Index Interval 0.129 to 3.784	2.709 Sample Index Interval 0.181 to 3.858

SECONDARY outcome

Timeframe: Day 28

Population: This outcome requires data from outcome #9. As outcome #9 was determined to be non-informative and was not run on the entire cohort, we do not have the necessary data to calculate this outcome on the entire cohort. Results are reported for the participants' samples for whom outcome #9 was reported from the optimization analyses.

Flow cytometry analysis of T cells. The results show the ratio of CD4+ T cells compared to CD8+ T cells present in each subject's PBMCs.

Outcome measures

Outcome measures
Measure	Fluad Vaccine n=5 Participants Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=4 Participants Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
CD4/CD8 Ratio	2.92 Ratio Interval 1.86 to 3.4	1.69 Ratio Interval 1.34 to 3.46

Adverse Events

Fluad Vaccine

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Fluzone Vaccine

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Richard Kennedy, PhD

Mayo Clinic

Phone: 507-284-0708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fluad Vaccine n=120 participants at risk Subjects receive a single dose of the Fluad influenza vaccine. Fluad Vaccine: FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.	Fluzone Vaccine n=121 participants at risk Subjects receive a single dose of the Fluzone High-Dose influenza vaccine. Fluzone High-Dose: FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
Musculoskeletal and connective tissue disorders Sore Arm	13.3% 16/120 • Number of events 16 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	9.1% 11/121 • Number of events 11 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Dizzy	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	1.7% 2/121 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Nervous system disorders Body Aches	4.2% 5/120 • Number of events 5 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Nervous system disorders Headache	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	2.5% 3/121 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Fatigue	5.8% 7/120 • Number of events 7 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	1.7% 2/121 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Trouble with blood draw	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Renal and urinary disorders Urinary Tract Infection	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Cold Symptoms	4.2% 5/120 • Number of events 5 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	2.5% 3/121 • Number of events 3 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Respiratory, thoracic and mediastinal disorders Cough	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	1.7% 2/121 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Swollen neck gland	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Allergies	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	1.7% 2/121 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Musculoskeletal and connective tissue disorders Foot Pain	1.7% 2/120 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
General disorders Bruised Arm	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Gastrointestinal disorders Diarrhea	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Gastrointestinal disorders Vomiting	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Gastrointestinal disorders Upset Stomach	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Nervous system disorders Bell's Palsy	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Cardiac disorders Stroke	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Gastrointestinal disorders GI Bleed	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Musculoskeletal and connective tissue disorders Diagnosis of Fibromyalgia	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Renal and urinary disorders Acute Kidney Failure	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/120 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.83% 1/121 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.
Cardiac disorders Elevated Blood Pressure	0.83% 1/120 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.	0.00% 0/121 • Adverse events were collected from baseline to end of study for a total of approximately 28 days on all participants.