A Study to Evaluate the Safety, Tolerability, and Immunog... | NCT03615482

ID	Type	Description	Link
V114-021	Other Identifier	Merck Protocol Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Concomitant Vaccination	Experimental	Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 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	Biological: V114 Biological: QIV Biological: Matching Placebo for V114
Non-concomitant Vaccination	Experimental	Participants will receive 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 V114 on Day 30	Biological: V114 Biological: QIV Biological: Matching Placebo for V114

Name	Type	Description	Arm Group Labels	Other Names
V114	Biological	Single 0.5 mL injection	Concomitant Vaccination Non-concomitant Vaccination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Solicited Injection-site Adverse Event	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tenderness, swelling.	Up to Day 5 after vaccination
Percentage of Participants With a Solicited Systemic Adverse Event	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs included myalgia/muscle pain, arthralgia/joint pain, headache, and fatigue/tiredness.	Up to Day 14 after any vaccination
Percentage of Participants With a Vaccine-Related Serious Adverse Event	A serious adverse event (SAE) is an AE that results in death, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.	Up to 7 months
Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)	Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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.

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG)	Serotype-specific IgG GMC ratios (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In good health. Any underlying chronic illness must be documented to be in stable condition.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive methods as defined in the protocol during the treatment period and for at least 6 weeks after the last dose of study intervention.

Exclusion Criteria:

History of invasive pneumococcal disease (IPD, positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years before Visit 1 (Day 1)
Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
Known hypersensitivity to any component of influenza vaccines, including egg protein, or following a previous dose of any influenza vaccine.
Known or suspected impairment of immunological function
Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza vaccination
Coagulation disorder contraindicating intramuscular vaccinations.
History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
Prior administration of any PCV (e.g., Prevnar 13®) or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
Prior administration of PNEUMOVAX®23 ≤12 months before Visit 1 (Note: individuals who received PNEUMOVAX®23 >12 months prior to Visit 1 are eligible for this study.)
Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to receive any influenza vaccine during the study outside of the protocol
Received systemic corticosteroids (≥20 mg/day prednisone equivalent) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted).
Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received a blood transfusion or blood products, including immunoglobulin within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Achieve Clinical Research, LLC ( Site 0046)		Birmingham	Alabama	35216	United States
Synexus Clinical Research US, Inc. ( Site 0039)

PubMed Identifier	Type	Citation	Retractions
34726574	Background	Severance R, Schwartz H, Dagan R, Connor L, Li J, Pedley A, Hartzel J, Sterling TM, Nolan KM, Tamms GM, Musey LK, Buchwald UK. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged >/=50 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 10.1080/21645515.2021.1976581. Epub 2021 Nov 2.

ID	Title	Description
FG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
FG001	Non-Concomitant Group

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 1, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a Solicited Injection-site Adverse Event

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tenderness, swelling.

All randomized participants who received at least 1 dose of study vaccination were included. Of the 598 randomized to non-concomitant group, 1 received vaccination with concomitant group and was included (concomitant=600); 1 received 2 doses and was excluded (non-concomitant=596).

Posted

Number

Percentage of Participants

Up to Day 5 after vaccination

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Units	Counts
Participants	OG000600 OG001596

Title

Denominators

Categories

Injection-Site Erythema /Redness

Title	Measurements
	OG00010.7 OG00111.6

Injection-Site Pain /Tenderness

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Injection-Site Erythema	Miettinen & Nurminen	Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen & Nurminen method.	0.617		Difference in Percent	-0.9			2-Sided	95	-4.5	2.7					Other	Difference in Percent vs. Non-concomitant Group

Primary

Percentage of Participants With a Solicited Systemic Adverse Event

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs included myalgia/muscle pain, arthralgia/joint pain, headache, and fatigue/tiredness.

Posted

Number

Percentage of Participants

Up to Day 14 after any vaccination

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Primary

Percentage of Participants With a Vaccine-Related Serious Adverse Event

A serious adverse event (SAE) is an AE that results in death, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.

Posted

Number

Percentage of Participants

Up to 7 months

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Primary

Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)

Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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.

The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint.

Posted

Number

Titers

30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Primary

GMT of Influenza Strain-Specific Hemagglutination Inhibition

Activity for the 4 strains contained in QIV vaccine was determined using an hemagglutination inhibition (HAI) assay. Serotype-specific HAI GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method 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.

Posted

Number

Titers

Day 30

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Secondary

Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG)

Serotype-specific IgG GMC ratios (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated.

Posted

Number

µg/mL

30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Secondary

Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA

Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Units	Counts

Secondary

GMFR in Pneumococcal Serotype-Specific IgG

Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Units	Counts
Participants

Secondary

Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA

Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR were calculated from baseline to postvaccination.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Secondary

Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG

Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR are calculated from baseline to postvaccination.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Secondary

GMFR of Influenza Strain-Specific HAI

Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline (Day 1) and Day 30

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Units	Counts
Participants

Secondary

Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40

Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion is defined as achieving a 4-fold rise from baseline to postvaccination among participants who are seropositive at baseline (HAI titer ≥ 1:10) or a titer of ≥ 1:40 at postvaccination among participants who are seronegative at baseline (HAI titer < 1:10).

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 30

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Units	Counts

Secondary

Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI

Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion for HAI responses is defined as achieving either 1) a 4-fold rise in influenza strain-specific HAI titer from Baseline to Day 30 among participants who are seropositive at Baseline (HAI titer ≥1:10) or 2) a influenza strain-specific HAI titer of ≥1:40 at Day 30 among participants who are seronegative at Baseline (HAI titer <1:10).

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline (Day 1) and Day 30

ID	Title	Description
OG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
OG001	Non-Concomitant Group	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 V114 on Day 30.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0004 events3 affected600 at risk EG0010 events0 affected596 at risk
Coronary artery disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected600 at risk EG0011 events1 affected596 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected600 at risk EG0010 events0 affected596 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0012 events2 affected596 at risk
Chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Incarcerated hernia	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Encephalitis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Staphylococcal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0012 events2 affected596 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected600 at risk EG0011 events1 affected596 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0011 events1 affected596 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected600 at risk EG0011 events1 affected596 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk
Aortic stenosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected600 at risk EG0010 events0 affected596 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 22.1	Systematic Assessment	EG000242 events163 affected600 at risk EG001274 events179 affected596 at risk
Injection site erythema	General disorders	MedDRA 22.1	Systematic Assessment	EG00094 events65 affected600 at risk EG00187 events70 affected596 at risk
Injection site pain	General disorders	MedDRA 22.1	Systematic Assessment	EG000684 events413 affected600 at risk EG001710 events424 affected596 at risk
Injection site swelling	General disorders	MedDRA 22.1	Systematic Assessment	EG000124 events86 affected600 at risk EG001128 events99 affected596 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00069 events56 affected600 at risk EG00188 events69 affected596 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG000180 events142 affected600 at risk EG001154 events127 affected596 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG000183 events129 affected600 at risk EG001215 events143 affected596 at risk

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	Concomitant Group	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.
BG001	Non-Concomitant Group	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 V114 on Day 30.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Concomitant Group (V114, QIV, Placebo)	Participants received a single 0.5 mL intramuscular (IM) injection of V114 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.	1	600	22	600	458	600
EG001	Noncomitant Group (Placebo, QIV, V114)	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 V114 on Day 30.	0	600	14	596	473	596