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Trial record 1 of 1 for:    V116-006
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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05420961
Recruitment Status : Completed
First Posted : June 16, 2022
Results First Posted : May 1, 2024
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pneumonia, Pneumococcal
Interventions Biological: V116
Biological: PCV15
Biological: PPSV23
Enrollment 717
Recruitment Details  
Pre-assignment Details 717 adults were randomized to 1 of 3 cohorts. One participant randomized to receive PCV15 in Cohort 1 incorrectly received V116. Per protocol the participant was included in the Cohort 1 V116 group. One participant randomized to receive PCV15 in Cohort 1 incorrectly received PPSV23 (intervention for Cohort 2). Per protocol this participant was excluded from the all participants as treated population because the actual intervention received was not 1 of the 2 designated interventions in Cohort 1.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Period Title: Overall Study
Started 231 119 176 85 106
Day 1 - Vaccinated With V116 229 1 [1] 174 0 105
Day 1 - Vaccinated With PCV15 0 117 0 0 0
Day 1 - Vaccinated With PPSV23 0 1 [2] 0 85 0
Completed 229 118 173 85 105
Not Completed 2 1 3 0 1
Reason Not Completed
Withdrawal by Subject             2             1             1             0             0
Lost to Follow-up             0             0             1             0             0
Randomized by mistake without study treatment             0             0             1             0             1
[1]
This participant inadvertently received V116. Per protocol this participant was included in the Cohort 1 V116 group.
[2]
This participant inadvertently received PPSV23. Per protocol this participant was excluded from the all participants as treated (APaT) population because the actual intervention received was not one of the two designated interventions in Cohort 1.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116 Total
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. Total of all reporting groups
Overall Number of Baseline Participants 231 119 176 85 106 717
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 231 participants 119 participants 176 participants 85 participants 106 participants 717 participants
68.8  (7.5) 69.0  (7.1) 65.4  (7.8) 65.4  (6.6) 71.0  (7.6) 67.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 176 participants 85 participants 106 participants 717 participants
Female
117
  50.6%
60
  50.4%
101
  57.4%
49
  57.6%
56
  52.8%
383
  53.4%
Male
114
  49.4%
59
  49.6%
75
  42.6%
36
  42.4%
50
  47.2%
334
  46.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 176 participants 85 participants 106 participants 717 participants
Hispanic or Latino
22
   9.5%
17
  14.3%
34
  19.3%
16
  18.8%
14
  13.2%
103
  14.4%
Not Hispanic or Latino
207
  89.6%
102
  85.7%
142
  80.7%
69
  81.2%
92
  86.8%
612
  85.4%
Unknown or Not Reported
2
   0.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 176 participants 85 participants 106 participants 717 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
96
  41.6%
47
  39.5%
55
  31.3%
25
  29.4%
13
  12.3%
236
  32.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   2.6%
3
   2.5%
3
   1.7%
1
   1.2%
6
   5.7%
19
   2.6%
White
127
  55.0%
69
  58.0%
118
  67.0%
59
  69.4%
86
  81.1%
459
  64.0%
More than one race
2
   0.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
3
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Time Frame Up to 5 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 230 117 174 85 105
Measure Type: Number
Unit of Measure: Percentage of Participants
Injection site erythema 7.4 7.7 7.5 9.4 7.6
Injection site pain 35.7 43.6 41.4 47.1 43.8
Injection site swelling 8.3 8.5 4.6 16.5 10.5
2.Primary Outcome
Title Percentage of Participants With Solicited Systemic AEs
Hide Description An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Time Frame Up to 5 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 230 117 174 85 105
Measure Type: Number
Unit of Measure: Percentage of Participants
Fatigue 14.3 17.1 19.0 12.9 21.9
Headache 7.0 9.4 10.3 11.8 8.6
Myalgia 7.4 2.6 9.8 9.4 8.6
Pyrexia 1.7 2.6 2.9 1.2 0.0
3.Primary Outcome
Title Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Time Frame Up to ~180 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 230 117 174 85 105
Measure Type: Number
Unit of Measure: Percentage of Participants
0.4 0.0 0.0 0.0 0.0
4.Primary Outcome
Title Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Hide Description OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Time Frame 30 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 215 115 166 78 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 3 Number Analyzed 197 participants 103 participants 149 participants 75 participants 85 participants
262.1
(224.0 to 306.8)
226.3
(182.0 to 281.4)
391.1
(332.8 to 459.6)
583.1
(453.5 to 749.6)
318.3
(250.0 to 405.3)
Serotype 6A Number Analyzed 191 participants 94 participants 152 participants 74 participants 93 participants
1653.5
(1347.2 to 2029.4)
2076.1
(1571.4 to 2742.8)
3624.0
(3099.2 to 4237.7)
1812.3
(1226.6 to 2677.6)
2097.3
(1693.4 to 2597.6)
Serotype 7F Number Analyzed 209 participants 110 participants 150 participants 70 participants 96 participants
2184.4
(1891.4 to 2522.8)
1750.3
(1404.7 to 2181.0)
3129.8
(2609.9 to 3753.3)
4057.0
(3211.2 to 5125.6)
2051.3
(1630.2 to 2581.0)
Serotype 19A Number Analyzed 204 participants 109 participants 158 participants 74 participants 93 participants
1513.8
(1318.4 to 1738.1)
2022.9
(1634.1 to 2504.3)
2528.9
(2201.7 to 2904.9)
3241.5
(2646.0 to 3971.0)
1533.8
(1272.4 to 1848.9)
Serotype 22F Number Analyzed 206 participants 108 participants 143 participants 71 participants 99 participants
1983.8
(1698.3 to 2317.4)
1595.6
(1227.1 to 2074.6)
4389.2
(3541.1 to 5440.3)
2524.0
(1834.5 to 3472.5)
1913.5
(1453.5 to 2519.0)
Serotype 33F Number Analyzed 188 participants 99 participants 131 participants 59 participants 88 participants
4311.9
(3625.1 to 5128.9)
3397.2
(2665.3 to 4330.0)
8162.9
(6407.2 to 10399.7)
8761.9
(6157.4 to 12468.1)
4654.3
(3532.1 to 6133.1)
Serotype 8 Number Analyzed 208 participants 113 participants 161 participants 75 participants 98 participants
1273.0
(1115.1 to 1453.3)
345.8
(250.5 to 477.5)
2320.1
(1987.3 to 2708.7)
2723.2
(2197.4 to 3374.8)
1486.8
(1230.5 to 1796.6)
Serotype 9N Number Analyzed 191 participants 111 participants 143 participants 58 participants 90 participants
3805.1
(3324.0 to 4356.0)
2176.5
(1809.6 to 2617.9)
7214.4
(6062.9 to 8584.6)
6482.5
(4908.9 to 8560.7)
4054.5
(3389.4 to 4850.2)
Serotype 10A Number Analyzed 209 participants 112 participants 155 participants 73 participants 96 participants
1986.2
(1637.7 to 2408.9)
467.5
(337.0 to 648.5)
3976.8
(3360.7 to 4705.8)
1797.6
(1136.2 to 2843.9)
2564.0
(1959.1 to 3355.6)
Serotype 11A Number Analyzed 197 participants 100 participants 142 participants 71 participants 87 participants
1998.5
(1696.9 to 2353.8)
335.6
(228.9 to 491.8)
2846.6
(2411.0 to 3360.8)
1736.6
(1367.1 to 2206.1)
2373.0
(1905.4 to 2955.4)
Serotype 12F Number Analyzed 212 participants 114 participants 160 participants 73 participants 99 participants
981.8
(782.4 to 1232.1)
80.5
(54.0 to 120.1)
2252.6
(2120.5 to 3072.9)
1402.5
(912.2 to 2156.4)
1235.3
(948.3 to 1609.2)
Serotype 15A Number Analyzed 175 participants 93 participants 134 participants 63 participants 86 participants
4184.9
(3548.3 to 4935.6)
877.2
(616.2 to 1248.7)
6185.2
(5179.3 to 7386.6)
1668.2
(1234.4 to 2254.5)
4328.6
(3378.7 to 5545.7)
Serotype 15C Number Analyzed 206 participants 110 participants 152 participants 72 participants 89 participants
2307.8
(1878.4 to 2835.4)
539.6
(371.1 to 784.6)
4334.4
(3563.8 to 5271.5)
1470.4
(978.6 to 2209.3)
2191.9
(1573.2 to 3053.9)
Serotype 16F Number Analyzed 187 participants 107 participants 146 participants 74 participants 89 participants
3060.5
(2633.8 to 3556.3)
392.3
(301.3 to 510.8)
4626.5
(3861.8 to 5542.6)
832.8
(604.3 to 1147.6)
2477.0
(1887.2 to 3251.2)
Serotype 17F Number Analyzed 194 participants 108 participants 125 participants 67 participants 82 participants
3599.8
(3134.5 to 4134.3)
939.6
(693.7 to 1272.6)
5963.8
(5036.6 to 7061.7)
4367.3
(3372.5 to 5655.7)
3836.7
(3063.4 to 4805.1)
Serotype 20A Number Analyzed 195 participants 110 participants 138 participants 72 participants 88 participants
2847.4
(2433.3 to 3331.8)
1058.9
(829.9 to 1351.1)
6005.5
(4919.8 to 7330.8)
3393.9
(2536.9 to 4540.5)
2433.4
(1880.5 to 3148.9)
Serotype 23A Number Analyzed 202 participants 91 participants 156 participants 60 participants 86 participants
2363.9
(1857.4 to 3008.5)
310.2
(202.1 to 476.0)
4253.4
(3417.6 to 5293.5)
433.6
(247.5 to 759.5)
3967.2
(2764.8 to 5692.7)
Serotype 23B Number Analyzed 197 participants 110 participants 160 participants 75 participants 97 participants
673.2
(517.1 to 876.4)
153.0
(98.7 to 237.1)
1530.7
(1196.5 to 1958.3)
203.9
(127.6 to 325.6)
844.0
(608.2 to 1171.4)
Serotype 24F Number Analyzed 201 participants 97 participants 151 participants 63 participants 90 participants
1822.6
(1411.6 to 2353.3)
106.6
(69.7 to 162.9)
2746.1
(2257.9 to 3339.9)
48.5
(28.6 to 82.1)
2041.5
(1500.8 to 2777.1)
Serotype 31 Number Analyzed 194 participants 108 participants 146 participants 68 participants 90 participants
3018.4
(2473.6 to 3683.3)
113.2
(74.5 to 172.1)
4413.5
(3530.2 to 5517.7)
171.8
(99.9 to 295.6)
3285.5
(2485.0 to 4343.8)
Serotype 35B Number Analyzed 194 participants 107 participants 148 participants 76 participants 90 participants
6703.1
(5732.7 to 7837.8)
1019.1
(739.9 to 1403.7)
8143.5
(6761.4 to 9808.1)
1527.7
(1169.5 to 1995.5)
5836.8
(4693.6 to 7258.6)
5.Secondary Outcome
Title Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Hide Description The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Time Frame 30 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 220 117 167 81 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 3 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
0.87
(0.77 to 0.99)
0.80
(0.65 to 0.97)
0.89
(0.77 to 1.03)
1.58
(1.25 to 2.00)
0.85
(0.70 to 1.03)
Serotype 6A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
4.69
(3.72 to 5.90)
7.69
(5.60 to 10.57)
7.81
(6.30 to 9.68)
5.24
(3.62 to 7.56)
5.48
(4.27 to 7.03)
Serotype 7F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
5.71
(4.89 to 6.68)
6.45
(5.08 to 8.19)
5.65
(4.75 to 6.73)
8.34
(6.57 to 10.59)
5.07
(4.12 to 6.23)
Serotype 19A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
8.54
(7.33 to 9.95)
11.97
(9.40 to 15.24)
9.12
(7.70 to 10.81)
12.41
(9.57 to 16.11)
8.06
(6.50 to 9.98)
Serotype 22F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
4.41
(3.69 to 5.28)
4.33
(3.37 to 5.56)
5.38
(4.34 to 6.66)
2.87
(2.12 to 3.87)
3.08
(2.36 to 4.01)
Serotype 33F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
13.36
(11.22 to 15.91)
12.72
(10.37 to 15.61)
15.04
(12.31 to 18.37)
13.92
(10.23 to 18.94)
9.66
(7.53 to 12.40)
Serotype 8 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
9.58
(8.21 to 11.17)
3.56
(2.74 to 4.62)
11.29
(9.28 to 13.73)
14.47
(10.86 to 19.27)
7.48
(5.87 to 9.53)
Serotype 9N Number Analyzed 217 participants 117 participants 167 participants 81 participants 99 participants
7.06
(5.92 to 8.43)
3.59
(2.83 to 4.55)
8.48
(6.89 to 10.44)
7.32
(5.47 to 9.78)
4.15
(3.23 to 5.34)
Serotype 10A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
9.86
(7.99 to 12.18)
2.77
(2.12 to 3.63)
18.21
(14.30 to 23.18)
7.29
(4.94 to 10.74)
10.03
(7.21 to 13.98)
Serotype 11A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
7.16
(6.09 to 8.42)
2.06
(1.65 to 2.58)
9.13
(7.44 to 11.22)
3.95
(2.98 to 5.23)
4.78
(3.79 to 6.03)
Serotype 12F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
1.46
(1.18 to 1.81)
0.41
(0.30 to 0.55)
1.91
(1.44 to 2.53)
1.01
(0.65 to 1.56)
0.96
(0.70 to 1.31)
Serotype 15A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
16.35
(13.45 to 19.88)
1.56
(1.19 to 2.05)
20.24
(15.92 to 25.75)
2.15
(1.52 to 3.03)
11.16
(7.91 to 15.75)
Serotype 15C Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
11.08
(9.01 to 13.62)
3.25
(2.37 to 4.45)
16.67
(12.78 to 21.76)
4.31
(2.91 to 6.38)
6.51
(4.72 to 8.99)
Serotype 16F Number Analyzed 218 participants 117 participants 166 participants 81 participants 99 participants
4.69
(3.75 to 5.87)
0.37
(0.28 to 0.48)
4.04
(3.19 to 5.10)
0.30
(0.22 to 0.41)
2.46
(1.78 to 3.41)
Serotype 17F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
13.20
(11.18 to 15.58)
2.68
(2.08 to 3.46)
14.96
(12.37 to 18.08)
7.23
(5.26 to 9.92)
9.92
(7.86 to 12.53)
Serotype 20A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
14.83
(12.37 to 17.77)
4.93
(3.83 to 6.36)
22.21
(17.77 to 27.75)
10.73
(7.48 to 15.41)
12.16
(8.99 to 16.46)
Serotype 23A Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
5.38
(4.19 to 6.90)
0.75
(0.55 to 1.02)
6.03
(4.55 to 7.99)
0.62
(0.43 to 0.90)
4.25
(2.88 to 6.26)
Serotype 23B Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
6.66
(5.53 to 8.03)
2.61
(1.96 to 3.48)
6.00
(4.91 to 7.33)
2.31
(1.75 to 3.06)
5.05
(3.90 to 6.54)
Serotype 24F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
10.05
(7.59 to 13.32)
0.49
(0.39 to 0.61)
7.48
(5.45 to 10.46)
0.31
(0.23 to 0.42)
6.12
(3.84 to 9.75)
Serotype 31 Number Analyzed 217 participants 117 participants 167 participants 81 participants 99 participants
4.48
(3.66 to 5.48)
0.37
(0.30 to 0.47)
3.58
(2.87 to 4.46)
0.32
(0.24 to 0.44)
3.66
(2.64 to 5.08)
Serotype 35B Number Analyzed 218 participants 117 participants 167 participants 81 participants 99 participants
26.31
(21.60 to 32.04)
1.45
(1.18 to 1.78)
24.55
(20.09 to 30.01)
1.45
(1.17 to 1.80)
18.15
(13.61 to 24.21)
6.Secondary Outcome
Title Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Hide Description Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time Frame Day 1 (Baseline) and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 212 115 164 76 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Serotype 3 Number Analyzed 164 participants 91 participants 131 participants 68 participants 76 participants
4.4
(3.7 to 5.3)
4.0
(3.1 to 5.3)
6.2
(5.0 to 7.6)
7.5
(5.3 to 10.5)
5.0
(3.6 to 7.0)
Serotype 6A Number Analyzed 171 participants 87 participants 136 participants 66 participants 89 participants
6.2
(5.0 to 7.7)
7.1
(4.9 to 10.3)
4.2
(3.3 to 5.3)
1.8
(1.4 to 2.4)
5.5
(4.1 to 7.4)
Serotype 7F Number Analyzed 200 participants 102 participants 146 participants 69 participants 92 participants
4.1
(3.3 to 5.1)
3.9
(2.8 to 5.4)
4.6
(3.6 to 5.9)
4.2
(3.1 to 5.8)
3.9
(2.9 to 5.3)
Serotype 19A Number Analyzed 194 participants 104 participants 149 participants 72 participants 90 participants
2.4
(2.0 to 2.8)
3.3
(2.5 to 4.4)
2.8
(2.3 to 3.3)
3.6
(2.7 to 4.7)
2.5
(1.8 to 3.3)
Serotype 22F Number Analyzed 193 participants 102 participants 124 participants 64 participants 94 participants
7.0
(5.5 to 9.0)
7.1
(4.8 to 10.6)
26.3
(17.7 to 39.2)
14.8
(8.7 to 25.1)
7.5
(4.9 to 11.4)
Serotype 33F Number Analyzed 177 participants 93 participants 125 participants 50 participants 85 participants
2.2
(1.8 to 2.6)
1.7
(1.3 to 2.4)
6.3
(4.8 to 8.4)
9.2
(5.6 to 15.3)
2.7
(2.0 to 3.7)
Serotype 8 Number Analyzed 198 participants 108 participants 151 participants 71 participants 96 participants
2.8
(2.4 to 3.4)
0.9
(0.7 to 1.0)
16.6
(12.2 to 22.7)
18.6
(11.9 to 29.1)
3.8
(2.7 to 5.3)
Serotype 9N Number Analyzed 186 participants 108 participants 136 participants 53 participants 87 participants
2.3
(2.0 to 2.7)
1.4
(1.1 to 1.7)
5.9
(4.7 to 7.4)
6.8
(4.7 to 9.8)
3.5
(2.7 to 4.5)
Serotype 10A Number Analyzed 200 participants 111 participants 148 participants 71 participants 93 participants
4.3
(3.5 to 5.4)
1.0
(0.9 to 1.2)
17.1
(12.7 to 23.0)
11.8
(7.5 to 18.6)
4.7
(3.4 to 6.5)
Serotype 11A Number Analyzed 186 participants 91 participants 131 participants 65 participants 83 participants
6.5
(5.2 to 8.2)
1.2
(0.9 to 1.7)
21.0
(14.6 to 30.4)
9.2
(5.9 to 14.4)
9.5
(6.2 to 14.4)
Serotype 12F Number Analyzed 207 participants 112 participants 157 participants 72 participants 93 participants
11.8
(9.0 to 15.4)
1.1
(1.0 to 1.3)
82.2
(62.9 to 107.4)
41.9
(26.1 to 67.2)
13.7
(9.0 to 20.8)
Serotype 15A Number Analyzed 142 participants 78 participants 110 participants 40 participants 62 participants
5.6
(4.3 to 7.4)
1.2
(0.9 to 1.5)
9.0
(6.8 to 11.8)
3.0
(2.0 to 4.5)
7.2
(4.6 to 11.2)
Serotype 15C Number Analyzed 197 participants 108 participants 141 participants 68 participants 82 participants
8.5
(6.7 to 10.9)
1.3
(1.0 to 1.7)
30.6
(22.5 to 41.5)
12.7
(8.5 to 18.8)
11.6
(8.1 to 16.4)
Serotype 16F Number Analyzed 172 participants 100 participants 132 participants 68 participants 86 participants
7.1
(5.9 to 8.5)
1.1
(0.9 to 1.3)
9.8
(7.8 to 12.4)
2.0
(1.5 to 2.7)
7.2
(5.5 to 9.6)
Serotype 17F Number Analyzed 183 participants 101 participants 116 participants 64 participants 79 participants
3.7
(3.0 to 4.5)
0.9
(0.8 to 1.1)
13.5
(9.5 to 19.2)
8.1
(5.6 to 11.7)
6.5
(4.6 to 9.3)
Serotype 20A Number Analyzed 184 participants 105 participants 129 participants 69 participants 81 participants
3.7
(3.0 to 4.5)
0.9
(0.8 to 1.0)
12.2
(9.3 to 16.0)
6.0
(4.4 to 8.3)
4.4
(3.1 to 6.1)
Serotype 23A Number Analyzed 157 participants 76 participants 118 participants 38 participants 65 participants
8.4
(6.2 to 11.6)
1.4
(1.0 to 1.9)
19.0
(13.5 to 26.9)
2.5
(1.3 to 4.9)
16.3
(10.3 to 25.7)
Serotype 23B Number Analyzed 191 participants 109 participants 155 participants 71 participants 94 participants
21.4
(16.2 to 28.1)
4.2
(2.9 to 6.0)
35.5
(25.9 to 48.6)
5.2
(3.5 to 7.6)
26.1
(17.5 to 38.9)
Serotype 24F Number Analyzed 187 participants 91 participants 127 participants 61 participants 82 participants
25.8
(19.5 to 34.0)
1.0
(0.8 to 1.3)
31.1
(22.8 to 42.6)
0.9
(0.7 to 1.3)
39.5
(27.4 to 56.9)
Serotype 31 Number Analyzed 179 participants 97 participants 134 participants 61 participants 84 participants
16.7
(12.5 to 22.3)
0.9
(0.7 to 1.2)
35.6
(24.8 to 51.2)
1.7
(1.1 to 2.6)
30.5
(19.1 to 48.6)
Serotype 35B Number Analyzed 183 participants 106 participants 144 participants 71 participants 85 participants
6.0
(4.8 to 7.4)
1.0
(0.8 to 1.2)
7.2
(5.6 to 9.2)
1.4
(1.1 to 1.8)
5.7
(4.2 to 7.9)
7.Secondary Outcome
Title Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Hide Description Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Time Frame Day 1 (Baseline) and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 212 115 164 76 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 3 Number Analyzed 164 participants 91 participants 131 participants 68 participants 76 participants
54.9
(46.9 to 62.6)
54.9
(44.2 to 65.4)
64.1
(55.3 to 72.3)
66.2
(53.7 to 77.2)
48.7
(37.0 to 60.4)
Serotype 6A Number Analyzed 171 participants 87 participants 136 participants 66 participants 89 participants
57.9
(50.1 to 65.4)
58.6
(47.6 to 69.1)
46.3
(37.7 to 55.1)
18.2
(9.8 to 29.6)
56.2
(45.3 to 66.7)
Serotype 7F Number Analyzed 200 participants 102 participants 146 participants 69 participants 92 participants
38.5
(31.7 to 45.6)
43.1
(33.4 to 53.3)
44.5
(36.3 to 53.0)
49.3
(37.0 to 61.6)
38.0
(28.1 to 48.8)
Serotype 19A Number Analyzed 194 participants 104 participants 149 participants 72 participants 90 participants
28.4
(22.1 to 35.2)
34.6
(25.6 to 44.6)
33.6
(26.0 to 41.7)
38.9
(27.6 to 51.1)
30.0
(20.8 to 40.6)
Serotype 22F Number Analyzed 193 participants 102 participants 124 participants 64 participants 94 participants
53.9
(46.6 to 61.1)
54.9
(44.7 to 64.8)
77.4
(69.0 to 84.4)
65.6
(52.7 to 77.1)
50.0
(39.5 to 60.5)
Serotype 33F Number Analyzed 177 participants 93 participants 125 participants 50 participants 85 participants
19.8
(14.2 to 26.4)
19.4
(11.9 to 28.9)
52.0
(42.9 to 61.0)
56.0
(41.3 to 70.0)
29.4
(20.0 to 40.3)
Serotype 8 Number Analyzed 198 participants 108 participants 151 participants 71 participants 96 participants
33.3
(26.8 to 40.4)
2.8
(0.6 to 7.9)
70.2
(62.2 to 77.4)
74.6
(62.9 to 84.2)
34.4
(25.0 to 44.8)
Serotype 9N Number Analyzed 186 participants 108 participants 136 participants 53 participants 87 participants
22.0
(16.3 to 28.7)
6.5
(2.6 to 12.9)
57.4
(48.6 to 65.8)
67.9
(53.7 to 80.1)
39.1
(28.8 to 50.1)
Serotype 10A Number Analyzed 200 participants 111 participants 148 participants 71 participants 93 participants
46.0
(38.9 to 53.2)
2.7
(0.6 to 7.7)
74.3
(66.5 to 81.1)
67.6
(55.5 to 78.2)
49.5
(38.9 to 60.0)
Serotype 11A Number Analyzed 186 participants 91 participants 131 participants 65 participants 83 participants
53.8
(46.3 to 61.1)
12.1
(6.2 to 20.6)
73.3
(64.8 to 80.6)
53.8
(41.0 to 66.3)
59.0
(47.7 to 69.7)
Serotype 12F Number Analyzed 207 participants 112 participants 157 participants 72 participants 93 participants
62.8
(55.8 to 69.4)
6.3
(2.5 to 12.5)
93.0
(87.8 to 96.5)
81.9
(71.1 to 90.0)
60.2
(49.5 to 70.2)
Serotype 15A Number Analyzed 142 participants 78 participants 110 participants 40 participants 62 participants
53.5
(45.0 to 61.9)
12.8
(6.3 to 22.3)
70.9
(61.5 to 79.2)
35.0
(20.6 to 51.7)
59.7
(46.4 to 71.9)
Serotype 15C Number Analyzed 197 participants 108 participants 141 participants 68 participants 82 participants
61.4
(54.2 to 68.3)
10.2
(5.2 to 17.5)
84.4
(77.3 to 90.0)
72.1
(59.9 to 82.3)
72.0
(60.9 to 81.3)
Serotype 16F Number Analyzed 172 participants 100 participants 132 participants 68 participants 86 participants
68.0
(60.5 to 74.9)
8.0
(3.5 to 15.2)
70.5
(61.9 to 78.1)
30.9
(20.2 to 43.3)
70.9
(60.1 to 80.2)
Serotype 17F Number Analyzed 183 participants 101 participants 116 participants 64 participants 79 participants
37.7
(30.7 to 45.2)
2.0
(0.2 to 7.0)
74.1
(65.2 to 81.8)
62.5
(49.5 to 74.3)
54.4
(42.8 to 65.7)
Serotype 20A Number Analyzed 184 participants 105 participants 129 participants 69 participants 81 participants
37.5
(30.5 to 44.9)
2.9
(0.6 to 8.1)
76.7
(68.5 to 83.7)
60.9
(48.4 to 72.4)
46.9
(35.7 to 58.3)
Serotype 23A Number Analyzed 157 participants 76 participants 118 participants 38 participants 65 participants
59.9
(51.8 to 67.6)
21.1
(12.5 to 31.9)
73.7
(64.8 to 81.4)
34.2
(19.6 to 51.4)
80.0
(68.2 to 88.9)
Serotype 23B Number Analyzed 191 participants 109 participants 155 participants 71 participants 94 participants
74.9
(68.1 to 80.9)
40.4
(31.1 to 50.2)
80.6
(73.5 to 86.5)
43.7
(31.9 to 56.0)
80.9
(71.4 to 88.2)
Serotype 24F Number Analyzed 187 participants 91 participants 127 participants 61 participants 82 participants
80.2
(73.8 to 85.7)
7.7
(3.1 to 15.2)
81.9
(74.1 to 88.2)
4.9
(1.0 to 13.7)
89.0
(80.2 to 94.9)
Serotype 31 Number Analyzed 179 participants 97 participants 134 participants 61 participants 84 participants
70.9
(63.7 to 77.5)
8.2
(3.6 to 15.6)
81.3
(73.7 to 87.5)
18.0
(9.4 to 30.0)
82.1
(72.3 to 89.6)
Serotype 35B Number Analyzed 183 participants 106 participants 144 participants 71 participants 85 participants
55.2
(47.7 to 62.5)
7.5
(3.3 to 14.3)
65.3
(56.9 to 73.0)
7.0
(2.3 to 15.7)
57.6
(46.4 to 68.3)
8.Secondary Outcome
Title Geometric Mean Fold Rise of Serotype-specific IgG
Hide Description Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time Frame Day 1 (Baseline) and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 220 117 167 81 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Serotype 3 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
3.6
(3.2 to 4.0)
3.1
(2.6 to 3.7)
3.7
(3.2 to 4.3)
5.7
(4.3 to 7.4)
2.9
(2.3 to 3.5)
Serotype 6A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
5.9
(5.0 to 7.1)
8.0
(6.1 to 10.6)
3.3
(2.7 to 4.0)
2.5
(1.9 to 3.2)
4.4
(3.4 to 5.7)
Serotype 7F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
3.3
(2.8 to 3.8)
2.9
(2.3 to 3.5)
3.2
(2.7 to 3.8)
3.2
(2.6 to 3.9)
3.2
(2.6 to 4.0)
Serotype 19A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
2.3
(2.0 to 2.7)
3.4
(2.8 to 4.2)
2.2
(1.9 to 2.5)
3.0
(2.4 to 3.6)
2.0
(1.7 to 2.4)
Serotype 22F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
4.2
(3.6 to 4.9)
3.4
(2.8 to 4.2)
14.3
(11.4 to 18.0)
8.5
(6.2 to 11.6)
3.5
(2.7 to 4.6)
Serotype 33F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
2.2
(1.9 to 2.5)
1.8
(1.5 to 2.1)
8.6
(7.1 to 10.5)
10.5
(7.9 to 13.9)
2.4
(1.9 to 3.0)
Serotype 8 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
2.7
(2.4 to 3.1)
1.0
(0.9 to 1.1)
12.1
(9.8 to 15.0)
14.4
(10.3 to 20.0)
2.3
(1.9 to 2.8)
Serotype 9N Number Analyzed 217 participants 117 participants 167 participants 81 participants 99 participants
2.9
(2.4 to 3.4)
1.4
(1.2 to 1.6)
8.7
(7.1 to 10.6)
9.1
(6.8 to 12.1)
3.2
(2.6 to 3.9)
Serotype 10A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
4.4
(3.7 to 5.2)
1.0
(0.9 to 1.0)
18.9
(15.3 to 23.4)
10.1
(7.6 to 13.4)
4.2
(3.1 to 5.5)
Serotype 11A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
4.1
(3.6 to 4.7)
1.0
(0.9 to 1.0)
10.3
(8.5 to 12.6)
5.6
(4.4 to 7.2)
3.5
(2.7 to 4.3)
Serotype 12F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
4.2
(3.6 to 5.0)
1.0
(0.9 to 1.1)
14.2
(11.3 to 17.9)
8.4
(5.8 to 12.0)
3.5
(2.7 to 4.5)
Serotype 15A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
12.2
(10.1 to 14.7)
1.0
(0.9 to 1.1)
24.5
(19.7 to 30.3)
2.4
(2.0 to 3.0)
16.6
(12.0 to 22.9)
Serotype 15C Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
5.8
(4.9 to 6.9)
1.0
(0.9 to 1.2)
18.8
(14.9 to 23.8)
6.2
(4.8 to 8.2)
6.4
(5.0 to 8.1)
Serotype 16F Number Analyzed 218 participants 117 participants 166 participants 81 participants 99 participants
15.2
(12.7 to 18.2)
1.1
(1.0 to 1.2)
15.7
(12.9 to 19.0)
1.6
(1.3 to 1.8)
11.9
(9.2 to 15.4)
Serotype 17F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
4.7
(4.0 to 5.5)
1.0
(0.9 to 1.1)
17.4
(14.3 to 21.1)
10.5
(7.8 to 14.1)
3.8
(2.9 to 5.0)
Serotype 20A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
3.8
(3.3 to 4.4)
1.0
(0.9 to 1.1)
14.8
(12.2 to 17.9)
8.5
(6.4 to 11.4)
3.7
(2.9 to 4.8)
Serotype 23A Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
13.5
(11.1 to 16.5)
1.8
(1.5 to 2.2)
18.9
(15.3 to 23.4)
2.3
(1.9 to 2.7)
13.1
(9.6 to 17.7)
Serotype 23B Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
8.2
(6.7 to 10.0)
2.7
(2.1 to 3.5)
7.3
(6.0 to 8.9)
2.3
(1.9 to 2.9)
7.3
(5.4 to 9.7)
Serotype 24F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
26.9
(21.8 to 33.1)
1.0
(0.9 to 1.1)
21.7
(17.3 to 27.2)
1.0
(0.9 to 1.1)
24.4
(17.1 to 34.9)
Serotype 31 Number Analyzed 217 participants 117 participants 167 participants 81 participants 90 participants
13.1
(11.0 to 15.6)
1.1
(1.0 to 1.2)
14.4
(11.9 to 17.3)
1.5
(1.3 to 1.8)
13.0
(9.9 to 17.0)
Serotype 35B Number Analyzed 218 participants 117 participants 167 participants 81 participants 99 participants
16.8
(13.9 to 20.3)
1.0
(0.9 to 1.0)
15.6
(12.9 to 18.7)
0.9
(0.9 to 1.0)
15.7
(11.9 to 20.8)
9.Secondary Outcome
Title Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Hide Description Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Time Frame Day 1 (Baseline) and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description:
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
Overall Number of Participants Analyzed 220 117 167 81 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 3 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
42.7
(36.1 to 49.6)
36.8
(28.0 to 46.2)
40.7
(33.2 to 48.6)
54.3
(42.9 to 65.4)
35.4
(26.0 to 45.6)
Serotype 6A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
56.2
(49.3 to 62.8)
65.0
(55.6 to 73.5)
35.9
(28.7 to 43.7)
27.2
(17.9 to 38.2)
45.5
(35.4 to 55.8)
Serotype 7F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
34.7
(28.4 to 41.4)
29.9
(21.8 to 39.1)
37.7
(30.4 to 45.5)
33.3
(23.2 to 44.7)
37.4
(27.9 to 47.7)
Serotype 19A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
24.7
(19.1 to 30.9)
37.6
(28.8 to 47.0)
19.8
(14.0 to 26.6)
33.3
(23.2 to 44.7)
19.2
(12.0 to 28.3)
Serotype 22F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
39.3
(32.8 to 46.1)
35.0
(26.5 to 44.4)
78.4
(71.4 to 84.4)
65.4
(54.0 to 75.7)
43.4
(33.5 to 53.8)
Serotype 33F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
19.1
(14.1 to 24.9)
12.8
(7.4 to 20.3)
72.5
(65.0 to 79.1)
75.3
(64.5 to 84.2)
27.3
(18.8 to 37.1)
Serotype 8 Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
29.5
(23.6 to 36.0)
0.9
(0.0 to 4.7)
78.4
(71.4 to 84.4)
76.5
(65.8 to 85.2)
26.3
(17.9 to 36.1)
Serotype 9N Number Analyzed 217 participants 117 participants 167 participants 81 participants 99 participants
31.8
(25.7 to 38.4)
7.7
(3.6 to 14.1)
68.9
(61.2 to 75.8)
72.8
(61.8 to 82.1)
36.4
(26.9 to 46.6)
Serotype 10A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
45.5
(38.7 to 52.3)
0.9
(0.0 to 4.7)
82.6
(76.0 to 88.1)
80.2
(69.9 to 88.3)
46.5
(36.4 to 56.8)
Serotype 11A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
43.8
(37.2 to 50.7)
0.0
(0.0 to 3.1)
72.5
(65.0 to 79.1)
63.0
(51.5 to 73.4)
43.4
(33.5 to 53.8)
Serotype 12F Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
44.5
(37.9 to 51.4)
2.6
(0.5 to 7.3)
75.4
(68.2 to 81.8)
60.5
(49.0 to 71.2)
39.4
(29.7 to 49.7)
Serotype 15A Number Analyzed 220 participants 117 participants 167 participants 81 participants 99 participants
73.6
(67.3 to 79.3)
0.9
(0.0 to 4.7)
89.8
(84.2 to 94.0)
28.4
(18.9 to 39.5)
77.8
(68.3 to 85.5)
Serotype 15C Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
57.5
(50.7 to 64.2)
3.4
(0.9 to 8.5)
80.1
(73.2 to 85.9)
64.2
(52.8 to 74.6)
66.7
(56.5 to 75.8)
Serotype 16F Number Analyzed 218 participants 117 participants 166 participants 81 participants 99 participants
82.1
(76.4 to 87.0)
2.6
(0.5 to 7.3)
84.9
(78.6 to 90.0)
13.6
(7.0 to 23.0)
77.8
(68.3 to 85.5)
Serotype 17F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
48.9
(42.1 to 55.7)
1.7
(0.2 to 6.0)
83.8
(77.4 to 89.1)
74.1
(63.1 to 83.2)
44.4
(34.5 to 54.8)
Serotype 20A Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
36.5
(30.1 to 43.3)
0.9
(0.0 to 4.7)
83.2
(76.7 to 88.6)
69.1
(57.9 to 78.9)
49.5
(39.3 to 59.7)
Serotype 23A Number Analyzed 219 participants 117 participants 166 participants 81 participants 99 participants
77.6
(71.5 to 83.0)
17.1
(10.8 to 25.2)
86.7
(80.6 to 91.5)
21.0
(12.7 to 31.5)
77.8
(68.3 to 85.5)
Serotype 23B Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
64.8
(58.1 to 71.2)
26.5
(18.8 to 35.5)
60.5
(52.6 to 67.9)
21.0
(12.7 to 31.5)
64.6
(54.4 to 74.0)
Serotype 24F Number Analyzed 219 participants 117 participants 167 participants 81 participants 99 participants
85.4
(80.0 to 89.8)
0.0
(0.0 to 3.1)
88.0
(82.1 to 92.5)
0.0
(0.0 to 4.5)
83.8
(75.1 to 90.5)
Serotype 31 Number Analyzed 217 participants 117 participants 167 participants 81 participants 99 participants
79.7
(73.8 to 84.9)
2.6
(0.5 to 7.3)
84.4
(78.0 to 89.6)
11.1
(5.2 to 20.0)
80.8
(71.7 to 88.0)
Serotype 35B Number Analyzed 218 participants 117 participants 167 participants 81 participants 99 participants
83.9
(78.4 to 88.6)
0.0
(0.0 to 3.1)
82.6
(76.0 to 88.1)
0.0
(0.0 to 4.5)
84.8
(76.2 to 91.3)
Time Frame Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
Adverse Event Reporting Description The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
 
Arm/Group Title Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Hide Arm/Group Description Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
All-Cause Mortality
Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/231 (0.00%)      0/119 (0.00%)      0/176 (0.00%)      0/85 (0.00%)      0/106 (0.00%)    
Hide Serious Adverse Events
Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/230 (0.87%)      4/117 (3.42%)      2/174 (1.15%)      3/85 (3.53%)      2/105 (1.90%)    
Cardiac disorders           
Cardiac failure † 1  0/230 (0.00%)  0 1/117 (0.85%)  2 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Cardiac failure congestive † 1  1/230 (0.43%)  1 0/117 (0.00%)  0 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Myocardial ischaemia † 1  0/230 (0.00%)  0 1/117 (0.85%)  1 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Gastrointestinal disorders           
Anal fissure † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 1/174 (0.57%)  1 0/85 (0.00%)  0 0/105 (0.00%)  0
Aortoenteric fistula † 1  0/230 (0.00%)  0 1/117 (0.85%)  1 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Mallory-Weiss syndrome † 1  0/230 (0.00%)  0 1/117 (0.85%)  1 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Small intestinal perforation † 1  0/230 (0.00%)  0 1/117 (0.85%)  1 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Hepatobiliary disorders           
Cholangitis † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 0/174 (0.00%)  0 1/85 (1.18%)  1 0/105 (0.00%)  0
Cholelithiasis † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 0/174 (0.00%)  0 0/85 (0.00%)  0 1/105 (0.95%)  1
Infections and infestations           
Injection site cellulitis † 1  1/230 (0.43%)  1 0/117 (0.00%)  0 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Pneumonia † 1  0/230 (0.00%)  0 1/117 (0.85%)  2 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
Urinary tract infection † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 0/174 (0.00%)  0 0/85 (0.00%)  0 1/105 (0.95%)  1
Nervous system disorders           
Ischaemic stroke † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 0/174 (0.00%)  0 1/85 (1.18%)  1 0/105 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease † 1  0/230 (0.00%)  0 0/117 (0.00%)  0 1/174 (0.57%)  1 1/85 (1.18%)  1 0/105 (0.00%)  0
Vascular disorders           
Hypotension † 1  0/230 (0.00%)  0 1/117 (0.85%)  1 0/174 (0.00%)  0 0/85 (0.00%)  0 0/105 (0.00%)  0
1
Term from vocabulary, MedDRA 26.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/230 (46.52%)      66/117 (56.41%)      85/174 (48.85%)      52/85 (61.18%)      51/105 (48.57%)    
General disorders           
Fatigue † 1  33/230 (14.35%)  33 20/117 (17.09%)  20 33/174 (18.97%)  34 12/85 (14.12%)  12 23/105 (21.90%)  23
Injection site erythema † 1  19/230 (8.26%)  19 9/117 (7.69%)  9 14/174 (8.05%)  14 8/85 (9.41%)  8 8/105 (7.62%)  8
Injection site pain † 1  82/230 (35.65%)  82 51/117 (43.59%)  51 72/174 (41.38%)  72 40/85 (47.06%)  40 46/105 (43.81%)  46
Injection site swelling † 1  20/230 (8.70%)  20 10/117 (8.55%)  10 8/174 (4.60%)  8 14/85 (16.47%)  14 11/105 (10.48%)  11
Musculoskeletal and connective tissue disorders           
Myalgia † 1  17/230 (7.39%)  17 5/117 (4.27%)  5 17/174 (9.77%)  17 9/85 (10.59%)  9 9/105 (8.57%)  9
Nervous system disorders           
Headache † 1  17/230 (7.39%)  17 11/117 (9.40%)  11 18/174 (10.34%)  19 10/85 (11.76%)  10 9/105 (8.57%)  9
1
Term from vocabulary, MedDRA 26.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05420961    
Other Study ID Numbers: V116-006
jRCT2071220025 ( Registry Identifier: jRCT )
2021-006679-41 ( EudraCT Number )
First Submitted: June 13, 2022
First Posted: June 16, 2022
Results First Submitted: April 4, 2024
Results First Posted: May 1, 2024
Last Update Posted: May 7, 2024