Safety and Immunogenicity of V114 in Healthy Adults (V114... | NCT03950622

ID	Type	Description
2018-004316-22	Other Identifier	EudraCT Number
V114-019	Other Identifier	Merck
194845	Registry Identifier	Japic-CTI

Status Module

Label	Type	Description	Intervention Names
V114	Experimental	Single intramuscular (IM) dose at 0.5 mL of V114 pneumococcal conjugate vaccine at Visit 1 (Day 1)	Biological: V114
Prevnar 13™	Active Comparator	Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)	Biological: Prevnar 13®

Name	Type	Description	Arm Group Labels	Other Names
V114	Biological	15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.	V114

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 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 consist of redness/erythema, swelling, and tenderness/pain.	Up to Day 5 postvaccination
Percentage of Participants With Solicited Systemic Adverse Events	An 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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.	Up to Day 14 postvaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event	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 are reported to be at least possibly related by the investigator to study vaccination will be summarized.	Up to Month 6
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30	Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% CIs and 1-sided p-values 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. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) were determined using a multiplexed opsonophagocytic assay (MOPA). The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.

Secondary Outcomes

Measure	Description	Time Frame
GMT of Serotype-specific OPA for Serotype 3 at Day 30	Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a 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. OPA for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.
Male or female ≥50 years of age at the time of signing the informed consent. (For Japan only: Is male or female ≥65 years of age at the time of signing the informed consent)
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.
Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

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 of Visit 1 (Day 1).
Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.
Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
Coagulation disorder contraindicating intramuscular (IM) vaccinations.
Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.
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).
Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
Has 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.)
Is 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.
Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)
Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine.
Has 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.
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.
In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.
History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.
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
Synexus ( Site 1001)		Mesa	Arizona	85206	United States
Artemis Institute for Clinical Research ( Site 1012)

PubMed Identifier	Type	Citation	Retractions
34507861	Derived	Platt HL, Cardona JF, Haranaka M, Schwartz HI, Narejos Perez S, Dowell A, Chang CJ, Dagan R, Tamms GM, Sterling T, Morgan L, Shi Y, Pedley A, Musey LK, Buchwald UK. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine. 2022 Jan 3;40(1):162-172. doi: 10.1016/j.vaccine.2021.08.049. Epub 2021 Sep 8.

ID	Title	Description
FG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
FG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

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	Feb 13, 2020

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 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 consist of redness/erythema, swelling, and tenderness/pain.

The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.

Posted

Number

Percentage of Participants

Up to Day 5 postvaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants	OG000602 OG001600

Title

Denominators

Categories

Injection site erythema

Title	Measurements
	OG0009.0 OG00111.3

Injection site pain

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 redness/erythema	Miettinen & Nurminen		0.175		Difference in Percent	-2.4			2-Sided	95	-5.8	1.1					Other	Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

Primary

Percentage of Participants With Solicited Systemic Adverse Events

An 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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.

The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.

Posted

Number

Percentage of Participants

Up to Day 14 postvaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Primary

Percentage of Participants With a Vaccine-related Serious Adverse Event

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 are reported to be at least possibly related by the investigator to study vaccination will be summarized.

The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.

Posted

Number

Percentage of Participants

Up to Month 6

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Primary

Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30

Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% CIs and 1-sided p-values 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. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) were determined using a multiplexed opsonophagocytic assay (MOPA). The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

Titers

Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Primary

Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes

Activity for the serotypes contained in Prevnar 13™ and V114 was determined using a multiplexed opsonophagocytic assay (MOPA). The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline (Day 1) to 30 days postvaccination (Day 30) for OPA responses for the 2 unique serotypes in V114. The observed response percentage (m/n) included: m=the number of participants with the indicated response divided by n=the number of participants contributing to the analysis. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

Percentage of Participants

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Secondary

GMT of Serotype-specific OPA for Serotype 3 at Day 30

Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a 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. OPA for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

Titers

Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Secondary

Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses

Activity for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The observed response percentage of participants (m/n) who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. n=Number of participants contributing to the analysis; m=Number of participants with the indicated response. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

Percentage of Participants

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Secondary

Geometric Mean Concentration of Serotype-specific IgG at Day 30

Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a cLDA model 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. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The measure type of "number" presented in the data table below for serotype-specific IgG concentration is the geometric mean.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

µg/mL

Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Secondary

Geometric Mean Fold Rise in Serotype-specific OPA

Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Secondary

Geometric Mean Fold Rise in Serotype-specific IgG

Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer

Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration

Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination.

The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 1 (Baseline) and Day 30

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Angina unstable	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Arrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected602 at risk EG0010 events0 affected600 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected602 at risk EG0011 events1 affected600 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG000144 events105 affected602 at risk EG001140 events104 affected600 at risk
Injection site erythema	General disorders	MedDRA 23.0	Systematic Assessment	EG00062 events60 affected602 at risk EG00177 events73 affected600 at risk
Injection site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG000367 events327 affected602 at risk EG001294 events257 affected600 at risk
Injection site swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG00079 events76 affected602 at risk EG00178 events73 affected600 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00038 events32 affected602 at risk EG00139 events33 affected600 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG000111 events93 affected602 at risk EG00185 events72 affected600 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00093 events70 affected602 at risk EG001105 events78 affected600 at risk

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

ID	Title	Description
BG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
BG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
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	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.	1	604	9	602	395	602
EG001	PCV13	Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.	1	601	13	600	336	600