Trial Outcomes & Findings for The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002) (NCT NCT01513551)

NCT ID: NCT01513551

Last Updated: 2018-12-13

Results Overview

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 692 participants
• Primary outcome timeframe: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination
• Results posted on: 2018-12-13

Participant Flow

This trial was conducted at 25 trial centers: 10 in the United States; 2 in Canada; 2 in Denmark; 2 in Israel; 2 in Norway, 3 in Poland, 2 in Spain and 2 in Sweden.

Participant milestones

Measure	V114 Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Overall Study STARTED	230	231	231
Overall Study Vaccinated	230	231	230
Overall Study COMPLETED	226	225	226
Overall Study NOT COMPLETED	4	6	5

Reasons for withdrawal

Measure	V114 Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Overall Study Death	0	1	0
Overall Study Lost to Follow-up	3	5	2
Overall Study Withdrawal by Subject	1	0	2
Overall Study Randomized but not vaccinated	0	0	1

Baseline Characteristics

The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

Baseline characteristics by cohort

Measure	V114 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=231 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.	Total n=691 Participants Total of all reporting groups
Age, Customized 50 to 64 years	79 Participants n=5 Participants	80 Participants n=7 Participants	80 Participants n=5 Participants	239 Participants n=4 Participants
Age, Customized 65 to 74 years	75 Participants n=5 Participants	76 Participants n=7 Participants	74 Participants n=5 Participants	225 Participants n=4 Participants
Age, Customized >= 75 years	76 Participants n=5 Participants	75 Participants n=7 Participants	76 Participants n=5 Participants	227 Participants n=4 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	123 Participants n=7 Participants	122 Participants n=5 Participants	367 Participants n=4 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	108 Participants n=7 Participants	108 Participants n=5 Participants	324 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	216 Participants n=5 Participants	211 Participants n=7 Participants	215 Participants n=5 Participants	642 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) White	212 Participants n=5 Participants	217 Participants n=7 Participants	212 Participants n=5 Participants	641 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination

Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

Outcome measures

Measure	V114 n=229 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Percentage of Participants With an Adverse Event	75.1 Percentage of Participants	68.3 Percentage of Participants	65.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.

Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.

Outcome measures

Measure	V114 n=229 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site swelling	20.1 Percentage of Participants	10.9 Percentage of Participants	18.3 Percentage of Participants
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site warmth	0.9 Percentage of Participants	0.0 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site erythema	14.8 Percentage of Participants	14.8 Percentage of Participants	13.0 Percentage of Participants
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site induration	14.8 Percentage of Participants	10.4 Percentage of Participants	12.6 Percentage of Participants
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site pain	60.3 Percentage of Participants	51.3 Percentage of Participants	53.0 Percentage of Participants
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups Injection site pruritus	3.1 Percentage of Participants	1.3 Percentage of Participants	2.2 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.

Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.

Outcome measures

Measure	V114 n=229 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups	48.5 Percentage of Participants	43.9 Percentage of Participants	45.6 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 6 months postvaccination

Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.

A serious adverse event (SAE) is an AE that results in death, is life threatening, 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.

Outcome measures

Measure	V114 n=229 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Percentage of Participants With a Serious Adverse Event	1.7 Percentage of Participants	3.0 Percentage of Participants	2.2 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 6 months postvaccination

Population: The analysis population consisted of those participants who received study vaccination and had safety follow-up.

A SAE is an AE that results in death, is life threatening, 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. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.

Outcome measures

Measure	V114 n=229 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Percentage of Participants With a Vaccine-related Serious Adverse Event	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: One month postvaccination

Population: The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.

Outcome measures

Measure	V114 n=210 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=207 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=212 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 1	3.76 µg/mL Interval 3.05 to 4.65	3.30 µg/mL Interval 2.68 to 4.07	3.12 µg/mL Interval 2.54 to 3.82
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 3	1.13 µg/mL Interval 0.96 to 1.35	0.57 µg/mL Interval 0.47 to 0.68	0.56 µg/mL Interval 0.47 to 0.66
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 4	1.96 µg/mL Interval 1.59 to 2.41	1.03 µg/mL Interval 0.83 to 1.27	2.09 µg/mL Interval 1.7 to 2.56
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 5	3.99 µg/mL Interval 3.23 to 4.92	2.70 µg/mL Interval 2.21 to 3.3	2.76 µg/mL Interval 2.21 to 3.44
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 6A	4.88 µg/mL Interval 3.73 to 6.39	1.14 µg/mL Interval 0.9 to 1.43	4.86 µg/mL Interval 3.86 to 6.13
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 6B	5.43 µg/mL Interval 4.11 to 7.17	2.01 µg/mL Interval 1.58 to 2.57	2.81 µg/mL Interval 2.19 to 3.62
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 7F	4.59 µg/mL Interval 3.72 to 5.66	3.74 µg/mL Interval 3.0 to 4.65	6.06 µg/mL Interval 4.91 to 7.48
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 9V	4.05 µg/mL Interval 3.32 to 4.93	2.72 µg/mL Interval 2.21 to 3.36	3.41 µg/mL Interval 2.77 to 4.2
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 14	8.56 µg/mL Interval 6.86 to 10.69	8.13 µg/mL Interval 6.38 to 10.36	8.90 µg/mL Interval 7.08 to 11.18
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 18C	8.00 µg/mL Interval 6.62 to 9.68	4.66 µg/mL Interval 3.73 to 5.82	6.83 µg/mL Interval 5.68 to 8.2
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 19A	9.36 µg/mL Interval 7.66 to 11.44	6.99 µg/mL Interval 5.67 to 8.61	11.36 µg/mL Interval 9.28 to 13.92
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 19F	3.35 µg/mL Interval 2.67 to 4.21	4.17 µg/mL Interval 3.32 to 5.24	4.80 µg/mL Interval 3.81 to 6.04
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 22F	5.21 µg/mL Interval 4.25 to 6.39	1.98 µg/mL Interval 1.61 to 2.44	0.38 µg/mL Interval 0.32 to 0.44
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 23F	5.55 µg/mL Interval 4.33 to 7.12	1.82 µg/mL Interval 1.44 to 2.3	3.41 µg/mL Interval 2.62 to 4.43
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Serotype 33F	11.56 µg/mL Interval 9.27 to 14.4	8.26 µg/mL Interval 6.52 to 10.47	0.85 µg/mL Interval 0.7 to 1.03

SECONDARY outcome

Timeframe: One month postvaccination

Population: The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.

OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)

Outcome measures

Measure	V114 n=210 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=207 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=212 Participants Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 33F	31116.90 Titer Interval 24612.69 to 39339.94	27560.15 Titer Interval 21471.19 to 35375.88	3129.94 Titer Interval 2441.58 to 4012.38
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 1	208.03 Titer Interval 156.36 to 276.78	117.87 Titer Interval 87.11 to 159.49	115.75 Titer Interval 85.72 to 156.31
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 3	595.16 Titer Interval 498.23 to 710.95	313.83 Titer Interval 256.64 to 383.76	256.76 Titer Interval 212.08 to 310.85
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 4	2875.79 Titer Interval 2215.61 to 3732.69	1099.88 Titer Interval 804.01 to 1504.63	3001.63 Titer Interval 2380.57 to 3784.72
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 5	712.21 Titer Interval 537.78 to 943.22	288.41 Titer Interval 210.03 to 396.06	372.35 Titer Interval 271.76 to 510.19
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 6A	4216.34 Titer Interval 2977.07 to 5971.49	490.60 Titer Interval 325.94 to 738.44	5251.47 Titer Interval 4114.87 to 6702.0
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 6B	6469.99 Titer Interval 4775.27 to 8766.16	1630.20 Titer Interval 1174.34 to 2263.03	4207.86 Titer Interval 3212.46 to 5511.7
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 7F	5148.66 Titer Interval 4170.62 to 6356.06	3665.62 Titer Interval 2722.58 to 4935.3	7816.74 Titer Interval 6358.89 to 9608.81
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 9V	3024.34 Titer Interval 2338.72 to 3910.96	1674.44 Titer Interval 1252.72 to 2238.12	2471.10 Titer Interval 1882.58 to 3243.6
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 14	4352.27 Titer Interval 3374.62 to 5613.15	3572.27 Titer Interval 2667.12 to 4784.61	4478.38 Titer Interval 3647.04 to 5499.22
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 18C	4631.86 Titer Interval 3730.53 to 5750.96	2438.57 Titer Interval 1839.33 to 3233.04	3358.41 Titer Interval 2665.75 to 4231.06
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 19A	3391.18 Titer Interval 2755.18 to 4174.0	2682.65 Titer Interval 2095.62 to 3434.12	4186.28 Titer Interval 3421.2 to 5122.46
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 19F	1201.17 Titer Interval 906.2 to 1592.15	1581.60 Titer Interval 1211.55 to 2064.67	1946.04 Titer Interval 1547.41 to 2447.35
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 22F	8329.52 Titer Interval 6542.87 to 10604.06	4382.78 Titer Interval 3359.6 to 5717.58	57.45 Titer Interval 37.29 to 88.5
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies Serotype 23F	2217.18 Titer Interval 1588.99 to 3093.71	378.41 Titer Interval 262.42 to 545.67	1197.80 Titer Interval 836.8 to 1714.53

Adverse Events

V114

Serious events: 4 serious events

Other events: 167 other events

Deaths: 0 deaths

PNEUMOVAX® 23

Serious events: 7 serious events

Other events: 149 other events

Deaths: 1 deaths

PREVNAR 13®

Serious events: 5 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Measure	V114 n=229 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Cardiac disorders Cardiac failure	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Cardiac disorders Coronary artery occlusion	0.44% 1/229 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Cardiac disorders Myocardial infarction	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Ear and labyrinth disorders Vertigo	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
General disorders Death	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Hepatobiliary disorders Cholecystitis	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Infections and infestations Appendicitis	0.44% 1/229 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.44% 1/229 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign urinary tract neoplasm	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/229 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.43% 1/230 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Psychiatric disorders Anxiety	0.44% 1/229 • Number of events 1 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	0.00% 0/230 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.

Other adverse events

Measure	V114 n=229 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.	PNEUMOVAX® 23 n=230 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.	PREVNAR 13® n=230 participants at risk Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
General disorders Fatigue	24.9% 57/229 • Number of events 68 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	27.4% 63/230 • Number of events 89 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	23.9% 55/230 • Number of events 75 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
General disorders Injection site erythema	14.8% 34/229 • Number of events 37 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	14.8% 34/230 • Number of events 34 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	13.0% 30/230 • Number of events 31 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
General disorders Injection site induration	14.8% 34/229 • Number of events 35 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	10.4% 24/230 • Number of events 24 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	12.6% 29/230 • Number of events 29 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
General disorders Injection site pain	60.3% 138/229 • Number of events 145 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	51.3% 118/230 • Number of events 126 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	53.0% 122/230 • Number of events 137 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
General disorders Injection site swelling	20.1% 46/229 • Number of events 48 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	10.9% 25/230 • Number of events 26 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	18.3% 42/230 • Number of events 42 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 41/229 • Number of events 45 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	11.3% 26/230 • Number of events 37 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	12.6% 29/230 • Number of events 41 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Musculoskeletal and connective tissue disorders Myalgia	30.1% 69/229 • Number of events 74 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	26.1% 60/230 • Number of events 72 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	21.7% 50/230 • Number of events 60 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
Nervous system disorders Headache	17.5% 40/229 • Number of events 43 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	17.8% 41/230 • Number of events 55 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.	18.3% 42/230 • Number of events 53 • Up to 6 months postvaccination The at-risk population consisted of all participants who received study vaccination and had safety follow-up.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER