A Phase 2 interventional study of V114-A and V114-B in Pneumococcal Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Prevention
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants
≥50 years of age in good health.
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 690 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
Biological: V114-A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1
Biological: V114-B
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1
Biological: Prevnar 13®
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).
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).
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.
Percentage of Participants With an Adverse Event (AE)
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.
Time frame: Up to 14 days after vaccination
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Time frame: Up to 14 days after vaccination
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Time frame: Up to 14 days after vaccination
Percentage of Participants With a Serious Adverse Event (SAE)
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Time frame: Up to 30 days after vaccination
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Time frame: Up to 30 days after vaccination
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
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).
Time frame: Day 30 (one month after vaccination)
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
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).
Time frame: Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
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.
Time frame: Baseline and Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
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.
Time frame: Baseline and Day 30 (one month after vaccination)
Healthy, pneumococcal vaccine-naïve adults ≥50 years of age were recruited at 23 sites in the United States.
| Milestone | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Started | 231 | 231 | 228 |
| Vaccinated | 231 | 231 | 227 |
| Completed | 228 | 226 | 224 |
| Not completed | 3 | 5 | 4 |
| Withdrew: Lost to follow-up | 3 | 1 | 1 |
| Withdrew: Not vaccinated | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 4 | 2 |
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.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Percentage of Participants With an Adverse Event (AE) | 74.9 | 72.3 | 67.4 |
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Erythema | 8.7 | 11.3 | 10.1 |
| Pain | 62.3 | 60.2 | 52.4 |
| Swelling | 11.7 | 16.5 | 12.3 |
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Arthralgia | 9.5 | 7.4 | 6.2 |
| Myalgia | 22.9 | 18.6 | 14.1 |
| Headache | 12.1 | 12.6 | 16.7 |
| Fatigue | 24.2 | 17.7 | 22.5 |
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Percentage of Participants With a Serious Adverse Event (SAE) | 0.4 | 0.9 | 0.0 |
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) | 0.0 | 0.0 | 0.0 |
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).
| Titers | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| CS1 | 196.79 (145.49 to 266.17) | 144.01 (106.06 to 195.54) | 127.19 (93.19 to 173.60) |
| CS3 | 104.78 (83.69 to 131.18) | 61.41 (48.99 to 76.97) | 33.10 (25.41 to 43.12) |
| CS4 | 1314.31 (1050.53 to 1644.31) | 929.53 (722.68 to 1195.57) | 1195.73 (931.75 to 1534.49) |
| CS5 | 273.79 (201.52 to 372.00) | 269.14 (197.57 to 366.63) | 283.83 (209.93 to 383.74) |
| CS6A | 3849.02 (2937.54 to 5043.31) | 4690.40 (3688.20 to 5964.93) | 4932.72 (3771.98 to 6450.62) |
| CS6B | 4552.54 (3680.12 to 5631.79) | 5082.56 (3984.20 to 6483.72) | 3909.05 (3005.43 to 5084.36) |
| CS7F | 2672.91 (2213.60 to 3227.51) | 2845.64 (2374.74 to 3409.92) | 3659.86 (3036.53 to 4411.14) |
| CS9V | 2514.21 (2014.06 to 3138.57) | 1962.09 (1558.28 to 2470.55) | 2112.91 (1685.97 to 2647.96) |
| CS14 | 3496.71 (2776.80 to 4403.25) | 2664.63 (2206.92 to 3217.26) | 3111.50 (2560.29 to 3781.38) |
| CS18C | 1896.14 (1540.37 to 2334.08) | 2687.10 (2169.85 to 3327.65) | 1528.79 (1208.83 to 1933.45) |
| CS19A | 1910.75 (1587.43 to 2299.92) | 2477.75 (2043.94 to 3003.63) | 2045.57 (1692.29 to 2472.59) |
| CS19F | 799.86 (636.72 to 1004.80) | 1084.99 (855.50 to 1376.04) | 810.05 (640.41 to 1024.61) |
| CS23F | 1233.60 (943.88 to 1612.25) | 2198.15 (1702.57 to 2837.99) | 1561.04 (1171.58 to 2079.96) |
| VS22F | 4743.78 (3737.99 to 6020.21) | 3976.66 (3141.02 to 5034.61) | 68.47 (48.39 to 96.88) |
| VS33F | 12457.52 (10076.61 to 15401.00) | 12614.22 (10236.84 to 15543.72) | 2111.66 (1681.43 to 2651.97) |
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).
| µg/mL | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| CS1 | 5.04 (4.10 to 6.19) | 4.00 (3.34 to 4.79) | 4.15 (3.40 to 5.07) |
| CS3 | 0.94 (0.78 to 1.12) | 0.61 (0.51 to 0.72) | 0.48 (0.39 to 0.58) |
| CS4 | 1.30 (1.07 to 1.58) | 0.96 (0.79 to 1.16) | 1.39 (1.12 to 1.73) |
| CS5 | 3.93 (3.08 to 5.02) | 3.40 (2.66 to 4.34) | 3.37 (2.66 to 4.28) |
| CS6A | 3.88 (2.98 to 5.06) | 4.56 (3.49 to 5.96) | 4.40 (3.29 to 5.88) |
| CS6B | 3.58 (2.78 to 4.63) | 4.71 (3.58 to 6.20) | 3.63 (2.72 to 4.85) |
| CS7F | 4.19 (3.41 to 5.15) | 4.43 (3.59 to 5.47) | 4.69 (3.78 to 5.84) |
| CS9V | 4.17 (3.39 to 5.12) | 3.73 (3.04 to 4.56) | 3.40 (2.74 to 4.22) |
| CS14 | 10.54 (8.36 to 13.30) | 6.51 (5.23 to 8.11) | 7.31 (5.79 to 9.22) |
| CS18C | 6.45 (5.21 to 7.98) | 6.51 (5.23 to 8.11) | 7.31 (5.79 to 9.22) |
| CS19A | 8.12 (6.63 to 9.94) | 14.89 (12.20 to 18.18) | 10.42 (8.66 to 12.52) |
| CS19F | 3.96 (3.14 to 4.98) | 7.17 (5.67 to 9.05) | 4.65 (3.81 to 5.68) |
| CS23F | 3.88 (3.03 to 4.97) | 5.49 (4.25 to 7.09) | 4.27 (3.27 to 5.57) |
| VS22F | 3.05 (2.48 to 3.75) | 2.75 (2.25 to 3.36) | 0.25 (0.20 to 0.30) |
| VS33F | 10.28 (8.33 to 12.67) | 7.46 (6.01 to 9.26) | 0.76 (0.60 to 0.96) |
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.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| CS1 | 70.9 (64.17 to 77.08) | 66.3 (59.31 to 72.86) | 61.7 (54.59 to 68.44) |
| CS3 | 71.8 (65.04 to 77.87) | 64.2 (57.13 to 70.80) | 44.1 (37.01 to 51.37) |
| CS4 | 84.8 (78.93 to 89.59) | 78.9 (72.19 to 84.61) | 81.6 (75.28 to 86.92) |
| CS5 | 68.2 (61.17 to 74.67) | 70.6 (63.67 to 76.93) | 67.2 (60.16 to 73.66) |
| CS6A | 85.1 (79.38 to 89.70) | 82.9 (76.95 to 87.87) | 82.9 (76.95 to 87.87) |
| CS6B | 87.0 (81.31 to 91.51) | 87.3 (81.55 to 91.77) | 84.2 (78.04 to 89.12) |
| CS7F | 67.9 (60.71 to 74.54) | 74.3 (67.54 to 80.38) | 75.0 (68.18 to 81.02) |
| CS9V | 64.6 (57.46 to 71.31) | 59.6 (52.19 to 66.65) | 60.5 (53.19 to 67.53) |
| CS14 | 61.6 (54.46 to 68.42) | 50.3 (43.06 to 57.44) | 48.3 (41.28 to 55.36) |
| CS18C | 74.9 (68.10 to 80.85) | 73.0 (65.97 to 79.23) | 64.3 (56.96 to 71.22) |
| CS19A | 74.9 (68.02 to 80.91) | 73.0 (66.17 to 79.04) | 71.1 (64.19 to 77.29) |
| CS19F | 74.2 (67.59 to 80.18) | 72.1 (65.40 to 78.22) | 75.5 (68.94 to 81.29) |
| CS22F | 76.6 (69.20 to 82.94) | 71.1 (63.55 to 77.85) | 14.5 (9.55 to 20.87) |
| VS23F | 76.3 (69.67 to 82.09) | 81.1 (74.68 to 86.45) | 78.9 (72.46 to 84.51) |
| VS33F | 53.5 (46.05 to 60.79) | 58.8 (51.27 to 66.02) | 8.8 (4.99 to 14.06) |
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.
| Percentage of Participants | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| CS1 | 78.2 (72.14 to 83.55) | 69.8 (63.15 to 75.83) | 65.4 (58.63 to 71.77) |
| CS3 | 58.3 (51.45 to 64.98) | 46.5 (39.70 to 53.42) | 31.3 (25.16 to 37.98) |
| CS4 | 71.8 (65.25 to 77.66) | 63.7 (56.91 to 70.15) | 62.1 (55.29 to 68.67) |
| CS5 | 52.3 (45.43 to 59.13) | 47.0 (40.16 to 53.88) | 48.1 (41.27 to 55.04) |
| CS6A | 73.6 (67.20 to 79.36) | 77.2 (71.01 to 82.64) | 77.1 (70.88 to 82.55) |
| CS6B | 75.5 (69.17 to 81.05) | 77.2 (71.01 to 82.64) | 66.4 (59.60 to 72.65) |
| CS7F | 69.4 (62.83 to 75.51) | 72.6 (66.08 to 78.41) | 69.6 (62.99 to 75.71) |
| CS9V | 73.1 (64.77 to 77.23) | 71.6 (65.10 to 77.55) | 65.0 (58.15 to 71.33) |
| CS14 | 57.9 (50.98 to 64.54) | 48.8 (41.98 to 55.73) | 49.1 (42.19 to 55.97) |
| CS18C | 71.8 (65.25 to 77.66) | 77.7 (71.51 to 83.06) | 70.6 (63.96 to 76.58) |
| CS19A | 65.3 (58.52 to 71.61) | 67.9 (61.22 to 74.09) | 64.5 (57.67 to 70.89) |
| CS19F | 59.7 (52.85 to 66.32) | 71.6 (65.10 to 77.55) | 62.6 (55.76 to 69.12) |
| CS22F | 71.3 (64.77 to 77.23) | 71.2 (64.61 to 77.12) | 1.9 (0.51 to 4.72) |
| VS23F | 72.2 (65.74 to 78.08) | 77.2 (71.01 to 82.64) | 71.5 (64.94 to 77.44) |
| VS33F | 72.7 (66.23 to 78.51) | 65.6 (58.82 to 71.91) | 0.9 (0.11 to 3.34) |
Collected over Up to 30 days after vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V114-A | 0/231 (0%) | 1/231 (0.4%) | 169/231 (73.2%) |
| V114-B | 0/231 (0%) | 2/231 (0.9%) | 163/231 (70.6%) |
| Prevnar 13® | 0/227 (0%) | 0/227 (0%) | 148/227 (65.2%) |
| Event | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 0/231 | 1/231 | 0/227 |
| OsteomyelitisInfections and infestations | 1/231 | 0/231 | 0/227 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/231 | 1/231 | 0/227 |
| Event | V114-A | V114-B | Prevnar 13® |
|---|---|---|---|
| Injection site painGeneral disorders | 145/231 | 140/231 | 124/227 |
| FatigueGeneral disorders | 56/231 | 41/231 | 51/227 |
| MyalgiaMusculoskeletal and connective tissue disorders | 53/231 | 43/231 | 32/227 |
| HeadacheNervous system disorders | 28/231 | 29/231 | 38/227 |
| Injection site swellingGeneral disorders | 29/231 | 38/231 | 29/227 |
| Injection site erythemaGeneral disorders | 22/231 | 29/231 | 24/227 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 22/231 | 17/231 | 14/227 |
The Baseline Analysis Population consists of all vaccinated participants.
| Age, Continuous(Years) | V114-A | V114-B | Prevnar 13® | Total |
|---|---|---|---|---|
| Mean | 63.4 ± 8.3 | 63.4 ± 8.3 | 63.1 ± 8.1 | 63.3 ± 8.2 |
| Sex: Female, Male(Participants) | V114-A | V114-B | Prevnar 13® | Total |
|---|---|---|---|---|
| Female | 126 | 126 | 133 | 385 |
| Male | 105 | 105 | 94 | 304 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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