Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) (NCT NCT02547649)
NCT ID: NCT02547649
Last Updated: 2019-04-16
Results Overview
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
690 participants
Primary outcome timeframe
Up to 14 days after vaccination
Results posted on
2019-04-16
Participant Flow
Healthy, pneumococcal vaccine-naïve adults ≥50 years of age were recruited at 23 sites in the United States.
Participant milestones
| Measure |
V114-A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
231
|
231
|
228
|
|
Overall Study
Vaccinated
|
231
|
231
|
227
|
|
Overall Study
COMPLETED
|
228
|
226
|
224
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
V114-A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
|
Overall Study
Not vaccinated
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
2
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
Baseline characteristics by cohort
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
Total
n=689 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.4 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
63.3 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All participants who received study vaccination are included.
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With an Adverse Event (AE)
|
74.9 Percentage of Participants
|
72.3 Percentage of Participants
|
67.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All participants who received study vaccination are included.
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Swelling
|
11.7 Percentage of Participants
|
16.5 Percentage of Participants
|
12.3 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Erythema
|
8.7 Percentage of Participants
|
11.3 Percentage of Participants
|
10.1 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Pain
|
62.3 Percentage of Participants
|
60.2 Percentage of Participants
|
52.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All participants who received study vaccination are included.
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Headache
|
12.1 Percentage of Participants
|
12.6 Percentage of Participants
|
16.7 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Fatigue
|
24.2 Percentage of Participants
|
17.7 Percentage of Participants
|
22.5 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Arthralgia
|
9.5 Percentage of Participants
|
7.4 Percentage of Participants
|
6.2 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Myalgia
|
22.9 Percentage of Participants
|
18.6 Percentage of Participants
|
14.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after vaccinationPopulation: All participants who received study vaccination are included.
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE)
|
0.4 Percentage of Participants
|
0.9 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after vaccinationPopulation: All participants who received study vaccination are included.
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 30 (one month after vaccination)Population: All vaccinated participants with data available are included.
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS1
|
196.79 Titers
Interval 145.49 to 266.17
|
144.01 Titers
Interval 106.06 to 195.54
|
127.19 Titers
Interval 93.19 to 173.6
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS3
|
104.78 Titers
Interval 83.69 to 131.18
|
61.41 Titers
Interval 48.99 to 76.97
|
33.10 Titers
Interval 25.41 to 43.12
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS4
|
1314.31 Titers
Interval 1050.53 to 1644.31
|
929.53 Titers
Interval 722.68 to 1195.57
|
1195.73 Titers
Interval 931.75 to 1534.49
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS5
|
273.79 Titers
Interval 201.52 to 372.0
|
269.14 Titers
Interval 197.57 to 366.63
|
283.83 Titers
Interval 209.93 to 383.74
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS6A
|
3849.02 Titers
Interval 2937.54 to 5043.31
|
4690.40 Titers
Interval 3688.2 to 5964.93
|
4932.72 Titers
Interval 3771.98 to 6450.62
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS9V
|
2514.21 Titers
Interval 2014.06 to 3138.57
|
1962.09 Titers
Interval 1558.28 to 2470.55
|
2112.91 Titers
Interval 1685.97 to 2647.96
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS19F
|
799.86 Titers
Interval 636.72 to 1004.8
|
1084.99 Titers
Interval 855.5 to 1376.04
|
810.05 Titers
Interval 640.41 to 1024.61
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS23F
|
1233.60 Titers
Interval 943.88 to 1612.25
|
2198.15 Titers
Interval 1702.57 to 2837.99
|
1561.04 Titers
Interval 1171.58 to 2079.96
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
VS22F
|
4743.78 Titers
Interval 3737.99 to 6020.21
|
3976.66 Titers
Interval 3141.02 to 5034.61
|
68.47 Titers
Interval 48.39 to 96.88
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
VS33F
|
12457.52 Titers
Interval 10076.61 to 15401.0
|
12614.22 Titers
Interval 10236.84 to 15543.72
|
2111.66 Titers
Interval 1681.43 to 2651.97
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS6B
|
4552.54 Titers
Interval 3680.12 to 5631.79
|
5082.56 Titers
Interval 3984.2 to 6483.72
|
3909.05 Titers
Interval 3005.43 to 5084.36
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS7F
|
2672.91 Titers
Interval 2213.6 to 3227.51
|
2845.64 Titers
Interval 2374.74 to 3409.92
|
3659.86 Titers
Interval 3036.53 to 4411.14
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS14
|
3496.71 Titers
Interval 2776.8 to 4403.25
|
2664.63 Titers
Interval 2206.92 to 3217.26
|
3111.50 Titers
Interval 2560.29 to 3781.38
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS18C
|
1896.14 Titers
Interval 1540.37 to 2334.08
|
2687.10 Titers
Interval 2169.85 to 3327.65
|
1528.79 Titers
Interval 1208.83 to 1933.45
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
CS19A
|
1910.75 Titers
Interval 1587.43 to 2299.92
|
2477.75 Titers
Interval 2043.94 to 3003.63
|
2045.57 Titers
Interval 1692.29 to 2472.59
|
SECONDARY outcome
Timeframe: Day 30 (one month after vaccination)Population: All vaccinated participants with data available are included.
The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS5
|
3.93 µg/mL
Interval 3.08 to 5.02
|
3.40 µg/mL
Interval 2.66 to 4.34
|
3.37 µg/mL
Interval 2.66 to 4.28
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS6A
|
3.88 µg/mL
Interval 2.98 to 5.06
|
4.56 µg/mL
Interval 3.49 to 5.96
|
4.40 µg/mL
Interval 3.29 to 5.88
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS6B
|
3.58 µg/mL
Interval 2.78 to 4.63
|
4.71 µg/mL
Interval 3.58 to 6.2
|
3.63 µg/mL
Interval 2.72 to 4.85
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS7F
|
4.19 µg/mL
Interval 3.41 to 5.15
|
4.43 µg/mL
Interval 3.59 to 5.47
|
4.69 µg/mL
Interval 3.78 to 5.84
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS9V
|
4.17 µg/mL
Interval 3.39 to 5.12
|
3.73 µg/mL
Interval 3.04 to 4.56
|
3.40 µg/mL
Interval 2.74 to 4.22
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS14
|
10.54 µg/mL
Interval 8.36 to 13.3
|
6.51 µg/mL
Interval 5.23 to 8.11
|
7.31 µg/mL
Interval 5.79 to 9.22
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS19A
|
8.12 µg/mL
Interval 6.63 to 9.94
|
14.89 µg/mL
Interval 12.2 to 18.18
|
10.42 µg/mL
Interval 8.66 to 12.52
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS19F
|
3.96 µg/mL
Interval 3.14 to 4.98
|
7.17 µg/mL
Interval 5.67 to 9.05
|
4.65 µg/mL
Interval 3.81 to 5.68
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS23F
|
3.88 µg/mL
Interval 3.03 to 4.97
|
5.49 µg/mL
Interval 4.25 to 7.09
|
4.27 µg/mL
Interval 3.27 to 5.57
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
VS22F
|
3.05 µg/mL
Interval 2.48 to 3.75
|
2.75 µg/mL
Interval 2.25 to 3.36
|
0.25 µg/mL
Interval 0.2 to 0.3
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS1
|
5.04 µg/mL
Interval 4.1 to 6.19
|
4.00 µg/mL
Interval 3.34 to 4.79
|
4.15 µg/mL
Interval 3.4 to 5.07
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS3
|
0.94 µg/mL
Interval 0.78 to 1.12
|
0.61 µg/mL
Interval 0.51 to 0.72
|
0.48 µg/mL
Interval 0.39 to 0.58
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS4
|
1.30 µg/mL
Interval 1.07 to 1.58
|
0.96 µg/mL
Interval 0.79 to 1.16
|
1.39 µg/mL
Interval 1.12 to 1.73
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
CS18C
|
6.45 µg/mL
Interval 5.21 to 7.98
|
6.51 µg/mL
Interval 5.23 to 8.11
|
7.31 µg/mL
Interval 5.79 to 9.22
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
VS33F
|
10.28 µg/mL
Interval 8.33 to 12.67
|
7.46 µg/mL
Interval 6.01 to 9.26
|
0.76 µg/mL
Interval 0.6 to 0.96
|
SECONDARY outcome
Timeframe: Baseline and Day 30 (one month after vaccination)Population: All vaccinated participants with data available are included.
The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS1
|
70.9 Percentage of Participants
Interval 64.17 to 77.08
|
66.3 Percentage of Participants
Interval 59.31 to 72.86
|
61.7 Percentage of Participants
Interval 54.59 to 68.44
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS3
|
71.8 Percentage of Participants
Interval 65.04 to 77.87
|
64.2 Percentage of Participants
Interval 57.13 to 70.8
|
44.1 Percentage of Participants
Interval 37.01 to 51.37
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS4
|
84.8 Percentage of Participants
Interval 78.93 to 89.59
|
78.9 Percentage of Participants
Interval 72.19 to 84.61
|
81.6 Percentage of Participants
Interval 75.28 to 86.92
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS5
|
68.2 Percentage of Participants
Interval 61.17 to 74.67
|
70.6 Percentage of Participants
Interval 63.67 to 76.93
|
67.2 Percentage of Participants
Interval 60.16 to 73.66
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS6A
|
85.1 Percentage of Participants
Interval 79.38 to 89.7
|
82.9 Percentage of Participants
Interval 76.95 to 87.87
|
82.9 Percentage of Participants
Interval 76.95 to 87.87
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS6B
|
87.0 Percentage of Participants
Interval 81.31 to 91.51
|
87.3 Percentage of Participants
Interval 81.55 to 91.77
|
84.2 Percentage of Participants
Interval 78.04 to 89.12
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS7F
|
67.9 Percentage of Participants
Interval 60.71 to 74.54
|
74.3 Percentage of Participants
Interval 67.54 to 80.38
|
75.0 Percentage of Participants
Interval 68.18 to 81.02
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS18C
|
74.9 Percentage of Participants
Interval 68.1 to 80.85
|
73.0 Percentage of Participants
Interval 65.97 to 79.23
|
64.3 Percentage of Participants
Interval 56.96 to 71.22
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS19A
|
74.9 Percentage of Participants
Interval 68.02 to 80.91
|
73.0 Percentage of Participants
Interval 66.17 to 79.04
|
71.1 Percentage of Participants
Interval 64.19 to 77.29
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS19F
|
74.2 Percentage of Participants
Interval 67.59 to 80.18
|
72.1 Percentage of Participants
Interval 65.4 to 78.22
|
75.5 Percentage of Participants
Interval 68.94 to 81.29
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS22F
|
76.6 Percentage of Participants
Interval 69.2 to 82.94
|
71.1 Percentage of Participants
Interval 63.55 to 77.85
|
14.5 Percentage of Participants
Interval 9.55 to 20.87
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
VS33F
|
53.5 Percentage of Participants
Interval 46.05 to 60.79
|
58.8 Percentage of Participants
Interval 51.27 to 66.02
|
8.8 Percentage of Participants
Interval 4.99 to 14.06
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS9V
|
64.6 Percentage of Participants
Interval 57.46 to 71.31
|
59.6 Percentage of Participants
Interval 52.19 to 66.65
|
60.5 Percentage of Participants
Interval 53.19 to 67.53
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
CS14
|
61.6 Percentage of Participants
Interval 54.46 to 68.42
|
50.3 Percentage of Participants
Interval 43.06 to 57.44
|
48.3 Percentage of Participants
Interval 41.28 to 55.36
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
VS23F
|
76.3 Percentage of Participants
Interval 69.67 to 82.09
|
81.1 Percentage of Participants
Interval 74.68 to 86.45
|
78.9 Percentage of Participants
Interval 72.46 to 84.51
|
SECONDARY outcome
Timeframe: Baseline and Day 30 (one month after vaccination)Population: All vaccinated participants with data available are included.
The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.
Outcome measures
| Measure |
V114-A
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 Participants
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 Participants
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS1
|
78.2 Percentage of Participants
Interval 72.14 to 83.55
|
69.8 Percentage of Participants
Interval 63.15 to 75.83
|
65.4 Percentage of Participants
Interval 58.63 to 71.77
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS3
|
58.3 Percentage of Participants
Interval 51.45 to 64.98
|
46.5 Percentage of Participants
Interval 39.7 to 53.42
|
31.3 Percentage of Participants
Interval 25.16 to 37.98
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS4
|
71.8 Percentage of Participants
Interval 65.25 to 77.66
|
63.7 Percentage of Participants
Interval 56.91 to 70.15
|
62.1 Percentage of Participants
Interval 55.29 to 68.67
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS5
|
52.3 Percentage of Participants
Interval 45.43 to 59.13
|
47.0 Percentage of Participants
Interval 40.16 to 53.88
|
48.1 Percentage of Participants
Interval 41.27 to 55.04
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS6A
|
73.6 Percentage of Participants
Interval 67.2 to 79.36
|
77.2 Percentage of Participants
Interval 71.01 to 82.64
|
77.1 Percentage of Participants
Interval 70.88 to 82.55
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS6B
|
75.5 Percentage of Participants
Interval 69.17 to 81.05
|
77.2 Percentage of Participants
Interval 71.01 to 82.64
|
66.4 Percentage of Participants
Interval 59.6 to 72.65
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS7F
|
69.4 Percentage of Participants
Interval 62.83 to 75.51
|
72.6 Percentage of Participants
Interval 66.08 to 78.41
|
69.6 Percentage of Participants
Interval 62.99 to 75.71
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS9V
|
73.1 Percentage of Participants
Interval 64.77 to 77.23
|
71.6 Percentage of Participants
Interval 65.1 to 77.55
|
65.0 Percentage of Participants
Interval 58.15 to 71.33
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS18C
|
71.8 Percentage of Participants
Interval 65.25 to 77.66
|
77.7 Percentage of Participants
Interval 71.51 to 83.06
|
70.6 Percentage of Participants
Interval 63.96 to 76.58
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS14
|
57.9 Percentage of Participants
Interval 50.98 to 64.54
|
48.8 Percentage of Participants
Interval 41.98 to 55.73
|
49.1 Percentage of Participants
Interval 42.19 to 55.97
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS19A
|
65.3 Percentage of Participants
Interval 58.52 to 71.61
|
67.9 Percentage of Participants
Interval 61.22 to 74.09
|
64.5 Percentage of Participants
Interval 57.67 to 70.89
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS19F
|
59.7 Percentage of Participants
Interval 52.85 to 66.32
|
71.6 Percentage of Participants
Interval 65.1 to 77.55
|
62.6 Percentage of Participants
Interval 55.76 to 69.12
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
CS22F
|
71.3 Percentage of Participants
Interval 64.77 to 77.23
|
71.2 Percentage of Participants
Interval 64.61 to 77.12
|
1.9 Percentage of Participants
Interval 0.51 to 4.72
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
VS23F
|
72.2 Percentage of Participants
Interval 65.74 to 78.08
|
77.2 Percentage of Participants
Interval 71.01 to 82.64
|
71.5 Percentage of Participants
Interval 64.94 to 77.44
|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
VS33F
|
72.7 Percentage of Participants
Interval 66.23 to 78.51
|
65.6 Percentage of Participants
Interval 58.82 to 71.91
|
0.9 Percentage of Participants
Interval 0.11 to 3.34
|
Adverse Events
V114-A
Serious events: 1 serious events
Other events: 169 other events
Deaths: 0 deaths
V114-B
Serious events: 2 serious events
Other events: 163 other events
Deaths: 0 deaths
Prevnar 13®
Serious events: 0 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114-A
n=231 participants at risk
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 participants at risk
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 participants at risk
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/231 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.43%
1/231 • Number of events 1 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.00%
0/227 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
Infections and infestations
Osteomyelitis
|
0.43%
1/231 • Number of events 1 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.00%
0/231 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.00%
0/227 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/231 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.43%
1/231 • Number of events 1 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
0.00%
0/227 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
Other adverse events
| Measure |
V114-A
n=231 participants at risk
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
|
V114-B
n=231 participants at risk
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
|
Prevnar 13®
n=227 participants at risk
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|---|
|
General disorders
Fatigue
|
24.2%
56/231 • Number of events 62 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
17.7%
41/231 • Number of events 44 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
22.5%
51/227 • Number of events 57 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
General disorders
Injection site erythema
|
9.5%
22/231 • Number of events 22 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
12.6%
29/231 • Number of events 30 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
10.6%
24/227 • Number of events 24 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
General disorders
Injection site pain
|
62.8%
145/231 • Number of events 159 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
60.6%
140/231 • Number of events 149 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
54.6%
124/227 • Number of events 134 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
General disorders
Injection site swelling
|
12.6%
29/231 • Number of events 29 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
16.5%
38/231 • Number of events 38 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
12.8%
29/227 • Number of events 29 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
22/231 • Number of events 22 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
7.4%
17/231 • Number of events 17 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
6.2%
14/227 • Number of events 17 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.9%
53/231 • Number of events 53 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
18.6%
43/231 • Number of events 45 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
14.1%
32/227 • Number of events 35 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
|
Nervous system disorders
Headache
|
12.1%
28/231 • Number of events 34 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
12.6%
29/231 • Number of events 35 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
16.7%
38/227 • Number of events 41 • Up to 30 days after vaccination
All participants who received study vaccination are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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 trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER