A Phase 2 interventional study of V114 Aluminum-adjuvanted and V114 Non-adjuvanted in Pneumococcal Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Prevention
This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 1,152 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; 132 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:
Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
Biological: V114 Aluminum-adjuvanted
Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
Biological: V114 Non-adjuvanted
Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.
Biological: Prevnar 13®
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 3
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 3
IgG GMCs for Postvaccination 4
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
Number of Participants With an Adverse Event (AE)
An 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.
Time frame: Up to Day 14 postvaccination
Number of Participants With an Injection-site AE
Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
Number of Participants With a Systemic AE
Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
Number of Participants With a Serious Adverse Event (SAE)
An 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.
Time frame: Up to one month after last dose of study vaccine
Number of Participants Who Discontinued the Study Due to an AE
An 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.
Time frame: Up to Day 14 postvaccination
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 3
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 3
OPA GMTs as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
This trial was conducted in 58 trial centers: 4 in Canada, 8 in Finland, 3 in Israel, 1 in Puerto Rico, 3 in Spain and 39 in the United States.
| Milestone | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Started | 378 | 386 | 378 |
| Completed | 320 | 327 | 326 |
| Not completed | 58 | 59 | 52 |
| Withdrew: Lost to follow-up | 22 | 22 | 16 |
| Withdrew: Adverse event | 1 | 1 | 3 |
| Withdrew: Physician decision | 2 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 32 | 34 | 31 |
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
| Percentage of Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 98.0 (95.7 to 99.3) | 96.2 (93.4 to 98.0) | 97.5 (95.1 to 98.9) |
| Serotype 3 | 93.3 (89.9 to 95.9) | 89.8 (86.0 to 92.9) | 69.2 (63.8 to 74.3) |
| Serotype 4 | 97.0 (94.4 to 98.6) | 94.0 (90.7 to 96.3) | 96.5 (93.8 to 98.2) |
| Serotype 5 | 95.7 (92.7 to 97.7) | 92.4 (88.9 to 95.1) | 96.2 (93.4 to 98.0) |
| Serotype 6A | 77.0 (71.8 to 81.6) | 78.4 (73.5 to 82.8) | 96.8 (94.2 to 98.5) |
| Serotype 6B | 73.7 (68.3 to 78.6) | 65.4 (59.9 to 70.6) | 87.6 (83.5 to 91.0) |
| Serotype 7F | 99.0 (97.1 to 100) | 99.4 (97.7 to 100) | 99.4 (97.7 to 100) |
| Serotype 9V | 95.0 (91.9 to 97.2) | 92.4 (88.9 to 95.1) | 97.5 (95.1 to 98.9) |
| Serotype 14 | 98.7 (96.6 to 100) | 98.4 (96.3 to 99.5) | 97.8 (95.5 to 99.1) |
| Serotype 18C | 96.7 (94.0 to 98.4) | 89.8 (86.0 to 92.9) | 97.5 (95.1 to 98.9) |
| Serotype 19A | 82.7 (77.9 to 86.8) | 84.4 (80.0 to 88.3) | 96.5 (93.8 to 98.2) |
| Serotype 19F | 91.3 (87.6 to 94.3) | 91.1 (87.4 to 94.0) | 99.4 (97.7 to 100) |
| Serotype 22F (non-PREVNAR 13® serotype) | 99.0 (97.1 to 100) | 99.4 (97.7 to 100) | 1.9 (0.7 to 4.1) |
| Serotype 23F | 87.7 (83.4 to 91.2) | 81.6 (76.9 to 85.7) | 90.8 (87.0 to 93.7) |
| Serotype 33F (non-PREVNAR 13® serotype) | 83.3 (78.6 to 87.4) | 84.8 (80.3 to 88.5) | 1.0 (0 to 2.8) |
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
| µg/mL | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 1.34 (1.24 to 1.45) | 1.38 (1.27 to 1.51) | 1.84 (1.69 to 2.01) |
| Serotype 3 | 0.95 (0.88 to 1.03) | 0.88 (0.81 to 0.96) | 0.50 (0.46 to 0.55) |
| Serotype 4 | 1.28 (1.18 to 1.39) | 1.26 (1.16 to 1.37) | 1.32 (1.22 to 1.43) |
| Serotype 5 | 1.61 (1.46 to 1.77) | 1.53 (1.38 to 1.71) | 1.83 (1.65 to 2.02) |
| Serotype 6A | 0.93 (0.80 to 1.08) | 0.93 (0.80 to 1.07) | 2.91 (2.62 to 3.24) |
| Serotype 6B | 0.95 (0.78 to 1.15) | 0.69 (0.57 to 0.84) | 1.47 (1.27 to 1.69) |
| Serotype 7F | 2.63 (2.41 to 2.87) | 2.66 (2.44 to 2.90) | 3.67 (3.40 to 3.97) |
| Serotype 9V | 1.49 (1.35 to 1.64) | 1.29 (1.16 to 1.44) | 1.79 (1.63 to 1.97) |
| Serotype 14 | 4.17 (3.76 to 4.63) | 3.84 (3.43 to 4.29) | 5.62 (5.02 to 6.28) |
| Serotype 18C | 1.27 (1.17 to 1.39) | 1.08 (0.97 to 1.20) | 1.99 (1.81 to 2.19) |
| Serotype 19A | 0.90 (0.80 to 1.00) | 0.94 (0.84 to 1.05) | 2.05 (1.85 to 2.27) |
| Serotype 19F | 1.50 (1.33 to 1.69) | 1.71 (1.52 to 1.93) | 2.54 (2.35 to 2.75) |
| Serotype 22F (non-PREVNAR 13® serotype) | 5.24 (4.74 to 5.79) | 4.86 (4.40 to 5.37) | 0.07 (0.06 to 0.07) |
| Serotype 23F | 1.05 (0.94 to 1.17) | 0.79 (0.69 to 0.89) | 1.41 (1.25 to 1.58) |
| Serotype 33F (non-PREVNAR 13® serotype) | 1.47 (1.24 to 1.73) | 1.50 (1.29 to 1.74) | 0.06 (0.06 to 0.07) |
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
| µg/mL | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 1.91 (1.73 to 2.10) | 1.81 (1.65 to 2.00) | 2.18 (1.99 to 2.38) |
| Serotype 3 | 1.26 (1.15 to 1.39) | 1.12 (1.04 to 1.22) | 0.69 (0.63 to 0.75) |
| Serotype 4 | 1.46 (1.30 to 1.65) | 1.40 (1.27 to 1.53) | 1.68 (1.52 to 1.86) |
| Serotype 5 | 1.93 (1.74 to 2.14) | 1.79 (1.63 to 1.97) | 2.53 (2.28 to 2.81) |
| Serotype 6A | 3.78 (3.37 to 4.26) | 3.17 (2.81 to 3.57) | 6.55 (5.89 to 7.28) |
| Serotype 6B | 5.24 (4.68 to 5.86) | 3.98 (3.52 to 4.51) | 5.51 (4.90 to 6.20) |
| Serotype 7F | 4.18 (3.76 to 4.64) | 3.43 (3.14 to 3.75) | 5.73 (5.24 to 6.28) |
| Serotype 9V | 2.82 (2.52 to 3.15) | 2.50 (2.28 to 2.75) | 3.37 (3.04 to 3.72) |
| Serotype 14 | 6.05 (5.37 to 6.82) | 5.55 (4.99 to 6.17) | 7.57 (6.81 to 8.42) |
| Serotype 18C | 2.14 (1.94 to 2.37) | 1.68 (1.54 to 1.83) | 3.37 (3.06 to 3.71) |
| Serotype 19A | 3.04 (2.72 to 3.40) | 3.42 (3.03 to 3.87) | 6.14 (5.57 to 6.78) |
| Serotype 19F | 5.56 (4.99 to 6.20) | 6.35 (5.68 to 7.09) | 4.51 (4.07 to 5.00) |
| Serotype 22F (non-PREVNAR 13® serotype) | 9.64 (8.74 to 10.62) | 7.73 (7.08 to 8.45) | 0.12 (0.11 to 0.14) |
| Serotype 23F | 1.99 (1.75 to 2.26) | 1.61 (1.43 to 1.80) | 3.14 (2.78 to 3.54) |
| Serotype 33F (non-PREVNAR 13® serotype) | 6.29 (5.62 to 7.05) | 4.95 (4.46 to 5.51) | 0.08 (0.08 to 0.09) |
An 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.
| Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Number of Participants With an Adverse Event (AE) | 349 | 359 | 354 |
Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
| Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Number of Participants With an Injection-site AE | 307 | 302 | 304 |
Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
| Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Number of Participants With a Systemic AE | 342 | 352 | 347 |
An 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.
| Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Number of Participants With a Serious Adverse Event (SAE) | 25 | 27 | 29 |
An 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.
| Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Number of Participants Who Discontinued the Study Due to an AE | 1 | 1 | 2 |
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
| Percentage of Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 80.0 (71.7 to 86.7) | 73.3 (64.5 to 81.0) | 77.7 (69.2 to 84.8) |
| Serotype 3 | 99.2 (95.4 to 100) | 100.0 (97.0 to 100) | 100.0 (97.0 to 100) |
| Serotype 4 | 100.0 (97.0 to 100) | 100.0 (96.9 to 100) | 100.0 (97.0 to 100) |
| Serotype 5 | 99.2 (95.4 to 100) | 95.8 (90.5 to 98.6) | 97.5 (93.0 to 99.5) |
| Serotype 6A | 89.2 (82.2 to 94.1) | 85.8 (78.3 to 91.5) | 100.0 (97.0 to 100) |
| Serotype 6B | 84.0 (76.2 to 90.1) | 80.0 (71.7 to 86.7) | 96.7 (91.8 to 99.1) |
| Serotype 7F | 100.0 (97.0 to 100) | 100.0 (97.0 to 100) | 100.0 (97.0 to 100) |
| Serotype 9V | 100.0 (97.0 to 100) | 98.3 (94.1 to 100) | 99.2 (95.5 to 100) |
| Serotype 14 | 100.0 (97.0 to 100) | 99.2 (95.4 to 100) | 100.0 (97.0 to 100) |
| Serotype 18C | 99.2 (95.4 to 100) | 96.7 (91.7 to 99.1) | 100.0 (97.0 to 100) |
| Serotype 19A | 92.5 (86.2 to 96.5) | 95.0 (89.3 to 98.1) | 95.9 (90.7 to 98.7) |
| Serotype 19F | 95.0 (89.4 to 98.1) | 95.8 (90.5 to 98.6) | 99.2 (95.5 to 100) |
| Serotype 22F (non-PREVNAR 13® serotype) | 99.2 (95.4 to 100) | 100.0 (97.0 to 100) | 11.6 (6.5 to 18.7) |
| Serotype 23F | 97.5 (92.9 to 99.5) | 96.6 (91.6 to 99.1) | 96.7 (91.8 to 99.1) |
| Serotype 33F (non-PREVNAR 13® serotype) | 97.5 (92.9 to 99.5) | 99.2 (95.4 to 100) | 60.7 (51.4 to 69.4) |
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
| Percentage of Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 96.6 (88.1 to 100) | 94.9 (85.9 to 98.9) | 96.0 (86.3 to 100) |
| Serotype 3 | 100.0 (93.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 4 | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 5 | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 6A | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 6B | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 7F | 100.0 (93.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 9V | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 14 | 100.0 (93.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 18C | 98.3 (90.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 19A | 98.3 (90.8 to 100) | 98.3 (90.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 19F | 96.6 (88.1 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 22F (non-PREVNAR 13® serotype) | 100.0 (93.8 to 100) | 100.0 (93.8 to 100) | 17.0 (7.6 to 30.8) |
| Serotype 23F | 100.0 (93.8 to 100) | 100.0 (93.9 to 100) | 100.0 (92.9 to 100) |
| Serotype 33F (non-PREVNAR 13® serotype) | 100.0 (93.8 to 100) | 100.0 (93.9 to 100) | 88.0 (75.7 to 95.5) |
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
| μg/mL | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 35.4 (25.4 to 49.3) | 32.4 (22.5 to 46.5) | 44.6 (31.2 to 63.7) |
| Serotype 3 | 296.7 (246.9 to 356.6) | 254.3 (215.9 to 299.6) | 209.9 (178.6 to 246.7) |
| Serotype 4 | 1672.9 (1414.3 to 1978.7) | 1633.1 (1384.3 to 1926.6) | 1911.6 (1608.0 to 2272.4) |
| Serotype 5 | 467.6 (369.4 to 591.7) | 337.0 (259.5 to 437.7) | 542.8 (416.8 to 706.7) |
| Serotype 6A | 1273.6 (807.3 to 2009.1) | 703.3 (435.4 to 1136.1) | 4009.7 (3316.0 to 4848.4) |
| Serotype 6B | 765.5 (463.2 to 1265.2) | 419.5 (244.8 to 719.0) | 1597.5 (1145.7 to 2227.4) |
| Serotype 7F | 5818.1 (4945.3 to 6844.8) | 5791.3 (4816.9 to 6962.9) | 10454.1 (8614.1 to 12687.0) |
| Serotype 9V | 2227.4 (1791.0 to 2770.1) | 1927.3 (1493.8 to 2486.5) | 2685.5 (2110.5 to 3417.1) |
| Serotype 14 | 2266.2 (1835.9 to 2797.2) | 1574.8 (1232.4 to 2012.3) | 2786.5 (2244.3 to 3459.7) |
| Serotype 18C | 1263.7 (1035.4 to 1542.2) | 846.6 (652.4 to 1098.8) | 2209.0 (1833.1 to 2662.0) |
| Serotype 19A | 551.7 (383.3 to 794.1) | 457.9 (331.1 to 633.3) | 1292.1 (921.9 to 1810.9) |
| Serotype 19F | 986.2 (714.0 to 1362.2) | 933.7 (665.8 to 1309.5) | 1417.1 (1145.4 to 1753.3) |
| Serotype 22F (non-PREVNAR 13® serotype) | 3048.8 (2484.3 to 3741.5) | 2714.4 (2302.6 to 3199.9) | 3.9 (2.8 to 5.5) |
| Serotype 23F | 1087.7 (821.8 to 1439.8) | 726.4 (530.3 to 995.1) | 3040.3 (2249.0 to 4110.1) |
| Serotype 33F (non-PREVNAR 13® serotype) | 25075.2 (16645.2 to 37774.5) | 28262.3 (20745.0 to 38503.5) | 66.6 (39.0 to 113.7) |
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
| μg/mL | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 139.1 (90.0 to 215.0) | 124.0 (79.6 to 192.9) | 133.1 (86.3 to 205.1) |
| Serotype 3 | 438.6 (344.8 to 557.9) | 405.2 (330.0 to 497.4) | 369.7 (293.8 to 465.0) |
| Serotype 4 | 1674.3 (1171.5 to 2392.9) | 1752.9 (1394.0 to 2204.0) | 2456.5 (1895.1 to 3184.2) |
| Serotype 5 | 680.8 (474.7 to 976.6) | 866.5 (648.5 to 1157.9) | 830.3 (602.1 to 1144.8) |
| Serotype 6A | 2583.6 (1667.0 to 4004.2) | 2835.9 (2171.6 to 3703.5) | 7382.0 (5445.2 to 10007.6) |
| Serotype 6B | 3866.8 (2723.7 to 5489.7) | 2265.1 (1559.4 to 3290.2) | 4686.1 (3058.7 to 7179.3) |
| Serotype 7F | 10205.9 (7487.6 to 13911.2) | 8543.2 (6622.6 to 11020.6) | 19147.5 (13725.9 to 26710.7) |
| Serotype 9V | 2888.0 (1985.0 to 4201.7) | 3339.1 (2457.9 to 4536.2) | 4901.5 (3740.3 to 6423.2) |
| Serotype 14 | 3543.1 (2508.3 to 5005.0) | 2877.7 (2088.7 to 3964.7) | 3872.9 (2762.1 to 5430.5) |
| Serotype 18C | 1327.0 (945.3 to 1862.8) | 1171.1 (928.6 to 1476.9) | 3214.7 (2438.0 to 4238.9) |
| Serotype 19A | 1871.0 (1282.1 to 2730.4) | 2260.8 (1604.8 to 3185.0) | 4519.7 (3028.7 to 6744.7) |
| Serotype 19F | 1885.8 (1226.6 to 2899.2) | 2949.8 (2273.6 to 3827.0) | 2624.6 (1866.0 to 3691.5) |
| Serotype 22F (non-PREVNAR 13® serotype) | 4586.5 (3406.2 to 6175.7) | 4497.0 (3594.5 to 5626.1) | 4.8 (2.6 to 8.8) |
| Serotype 23F | 3118.0 (2203.2 to 4412.6) | 2469.2 (1904.5 to 3201.4) | 11490.0 (7815.4 to 16892.4) |
| Serotype 33F (non-PREVNAR 13® serotype) | 59179.6 (43706.0 to 80131.4) | 54562.2 (38760.3 to 76806.2) | 815.8 (408.0 to 1631.3) |
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
| Percentage of Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 98.2 (95.8 to 99.4) | 98.0 (95.7 to 99.3) | 100.0 (98.7 to 100) |
| Serotype 3 | 96.0 (92.9 to 98.0) | 95.9 (93.0 to 97.9) | 80.9 (75.8 to 85.3) |
| Serotype 4 | 95.6 (92.5 to 97.7) | 96.3 (93.5 to 98.1) | 96.8 (94.0 to 98.5) |
| Serotype 5 | 99.3 (97.4 to 100) | 99.0 (97.1 to 100) | 98.9 (96.9 to 100) |
| Serotype 6A | 98.5 (96.3 to 100) | 97.3 (94.8 to 98.8) | 99.6 (98.0 to 100) |
| Serotype 6B | 99.3 (97.4 to 100) | 97.7 (95.2 to 99.1) | 98.9 (96.9 to 100) |
| Serotype 7F | 100.0 (98.7 to 100) | 99.0 (97.1 to 100) | 99.6 (98.0 to 100) |
| Serotype 9V | 98.9 (96.8 to 100) | 99.0 (97.1 to 100) | 99.6 (98.0 to 100) |
| Serotype 14 | 99.6 (98.0 to 100) | 99.7 (98.1 to 100) | 100.0 (98.7 to 100) |
| Serotype 18C | 98.5 (96.3 to 100) | 99.0 (97.1 to 100) | 100.0 (98.7 to 100) |
| Serotype 19A | 97.5 (94.8 to 99.0) | 98.7 (96.6 to 100) | 100.0 (98.7 to 100) |
| Serotype 19F | 99.3 (97.4 to 100) | 99.0 (97.1 to 100) | 99.3 (97.5 to 100) |
| Serotype 22F (non-PREVNAR 13® serotype) | 100.0 (98.7 to 100) | 99.7 (98.1 to 100) | 7.4 (4.7 to 11.1) |
| Serotype 23F | 95.6 (92.5 to 97.7) | 95.0 (91.8 to 97.2) | 98.9 (96.9 to 100) |
| Serotype 33F (non-PREVNAR 13® serotype) | 98.9 (96.8 to 100) | 98.3 (96.1 to 99.5) | 4.9 (2.7 to 8.2) |
Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
| Percentage of Participants | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Serotype 1 | 77.5 (72.1 to 82.3) | 76.5 (71.3 to 81.2) | 84.1 (79.3 to 88.2) |
| Serotype 3 | 63.6 (57.6 to 69.3) | 56.8 (50.9 to 62.5) | 30.9 (25.5 to 36.6) |
| Serotype 4 | 62.0 (56.0 to 67.8) | 65.1 (59.4 to 70.5) | 73.3 (67.7 to 78.4) |
| Serotype 5 | 79.6 (74.4 to 84.2) | 75.8 (70.6 to 80.6) | 85.1 (80.4 to 89.1) |
| Serotype 6A | 89.8 (85.6 to 93.1) | 89.2 (85.1 to 92.5) | 97.5 (94.9 to 99.0) |
| Serotype 6B | 97.1 (94.3 to 98.7) | 92.6 (89.0 to 95.3) | 95.4 (92.2 to 97.5) |
| Serotype 7F | 96.4 (93.4 to 98.2) | 97.0 (94.3 to 98.6) | 99.3 (97.5 to 100) |
| Serotype 9V | 88.6 (84.3 to 92.2) | 87.9 (83.7 to 91.4) | 91.5 (87.6 to 94.5) |
| Serotype 14 | 95.3 (92.1 to 97.5) | 97.0 (94.3 to 98.6) | 98.2 (95.9 to 99.4) |
| Serotype 18C | 83.6 (78.7 to 87.8) | 74.5 (69.2 to 79.3) | 95.0 (91.8 to 97.2) |
| Serotype 19A | 87.6 (83.2 to 91.3) | 87.9 (83.7 to 91.4) | 96.4 (93.6 to 98.3) |
| Serotype 19F | 95.3 (92.1 to 97.5) | 97.0 (94.3 to 98.6) | 95.7 (92.7 to 97.8) |
| Serotype 22F (non-PREVNAR 13® serotype) | 99.6 (98.0 to 100) | 98.7 (96.6 to 100) | 2.8 (1.2 to 5.5) |
| Serotype 23F | 76.4 (70.9 to 81.3) | 70.5 (64.9 to 75.6) | 86.4 (81.9 to 90.2) |
| Serotype 33F (non-PREVNAR 13® serotype) | 96.0 (92.9 to 98.0) | 96.6 (93.9 to 98.4) | 1.4 (0 to 3.6) |
Collected over Up to 1 month after final vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V114 | 1/368 (0.3%) | 25/368 (6.8%) | 345/368 (93.8%) |
| V114 Non-Adjuvanted | 1/382 (0.3%) | 27/382 (7.1%) | 348/382 (91.1%) |
| Prevnar | 2/376 (0.5%) | 29/376 (7.7%) | 347/376 (92.3%) |
| Event | V114 | V114 Non-Adjuvanted | Prevnar |
|---|---|---|---|
| Respiratory syncytial virus bronchiolitisInfections and infestations | 6/368 | 7/382 | 6/376 |
| BronchiolitisInfections and infestations | 5/368 | 6/382 | 4/376 |
| GastroenteritisInfections and infestations | 4/368 | 1/382 | 1/376 |
| CellulitisInfections and infestations | 1/368 | 0/382 | 3/376 |
| Gastritis viralInfections and infestations | 2/368 | 0/382 | 0/376 |
| InfluenzaInfections and infestations | 2/368 | 1/382 | 0/376 |
| Lobar pneumoniaInfections and infestations | 2/368 | 0/382 | 0/376 |
| PneumoniaInfections and infestations | 2/368 | 0/382 | 2/376 |
| PyrexiaGeneral disorders | 0/368 | 0/382 | 2/376 |
| Gastroenteritis viralInfections and infestations | 0/368 | 1/382 | 2/376 |
| Event | V114 | V114 Non-Adjuvanted | Prevnar |
|---|---|---|---|
| IrritabilityGeneral disorders | 315/368 | 311/382 | 306/376 |
| SomnolenceNervous system disorders | 263/368 | 281/382 | 265/376 |
| Injection site painGeneral disorders | 264/368 | 280/382 | 271/376 |
| Injection site erythemaGeneral disorders | 217/368 | 179/382 | 201/376 |
| Decreased appetiteMetabolism and nutrition disorders | 212/368 | 195/382 | 196/376 |
| Injection site swellingGeneral disorders | 181/368 | 132/382 | 165/376 |
| Injection site indurationGeneral disorders | 163/368 | 112/382 | 160/376 |
| PyrexiaGeneral disorders | 123/368 | 86/382 | 110/376 |
| Upper respiratory tract infectionInfections and infestations | 30/368 | 41/382 | 26/376 |
| DiarrhoeaGastrointestinal disorders | 36/368 | 26/382 | 36/376 |
| Age, Customized(Weeks) | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|
| Mean | 8.9 ± 1.2 | 8.8 ± 1.2 | 8.7 ± 1.1 | 8.8 ± 1.2 |
| Sex: Female, Male(Participants) | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|
| Female | 177 | 189 | 179 | 545 |
| Male | 201 | 197 | 199 | 597 |
| Ethnicity (NIH/OMB)(Participants) | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|
| Hispanic or Latino | 70 | 77 | 79 | 226 |
| Not Hispanic or Latino | 308 | 309 | 299 | 916 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 28 | 31 | 25 | 84 |
| Asian | 10 | 5 | 7 | 22 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 44 | 43 | 40 | 127 |
| White | 268 | 288 | 275 | 831 |
| More than one race | 27 | 18 | 31 | 76 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
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Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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