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A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

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: NCT01215188
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Interventions Biological: V114 Aluminum-adjuvanted
Biological: V114 Non-adjuvanted
Biological: Prevnar 13®
Enrollment 1152
Recruitment Details 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.
Pre-assignment Details There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description Participants received 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. Participants received 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. Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Period Title: Overall Study
Started 378 386 378
Completed 320 327 326
Not Completed 58 59 52
Reason Not Completed
Lost to Follow-up             22             22             16
Adverse Event             1             1             3
Physician Decision             2             1             0
Lack of Efficacy             0             0             1
Protocol Violation             1             1             1
Withdrawal by Subject             32             34             31
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13® Total
Hide Arm/Group Description Participants received 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. Participants received 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. Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. Total of all reporting groups
Overall Number of Baseline Participants 378 386 378 1142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 378 participants 386 participants 378 participants 1142 participants
8.9  (1.2) 8.8  (1.2) 8.7  (1.1) 8.8  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 378 participants 386 participants 378 participants 1142 participants
Female
177
  46.8%
189
  49.0%
179
  47.4%
545
  47.7%
Male
201
  53.2%
197
  51.0%
199
  52.6%
597
  52.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 378 participants 386 participants 378 participants 1142 participants
Hispanic or Latino
70
  18.5%
77
  19.9%
79
  20.9%
226
  19.8%
Not Hispanic or Latino
308
  81.5%
309
  80.1%
299
  79.1%
916
  80.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 378 participants 386 participants 378 participants 1142 participants
American Indian or Alaska Native
28
   7.4%
31
   8.0%
25
   6.6%
84
   7.4%
Asian
10
   2.6%
5
   1.3%
7
   1.9%
22
   1.9%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
44
  11.6%
43
  11.1%
40
  10.6%
127
  11.1%
White
268
  70.9%
288
  74.6%
275
  72.8%
831
  72.8%
More than one race
27
   7.1%
18
   4.7%
31
   8.2%
76
   6.7%
Unknown or Not Reported
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 300 315 315
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
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)
2.Primary Outcome
Title IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 300 315 315
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
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)
3.Primary Outcome
Title IgG GMCs for Postvaccination 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 275 298 283
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Serotype 1 Number Analyzed 275 participants 298 participants 283 participants
1.91
(1.73 to 2.10)
1.81
(1.65 to 2.00)
2.18
(1.99 to 2.38)
Serotype 3 Number Analyzed 272 participants 296 participants 282 participants
1.26
(1.15 to 1.39)
1.12
(1.04 to 1.22)
0.69
(0.63 to 0.75)
Serotype 4 Number Analyzed 274 participants 298 participants 281 participants
1.46
(1.30 to 1.65)
1.40
(1.27 to 1.53)
1.68
(1.52 to 1.86)
Serotype 5 Number Analyzed 275 participants 298 participants 282 participants
1.93
(1.74 to 2.14)
1.79
(1.63 to 1.97)
2.53
(2.28 to 2.81)
Serotype 6A Number Analyzed 274 participants 297 participants 279 participants
3.78
(3.37 to 4.26)
3.17
(2.81 to 3.57)
6.55
(5.89 to 7.28)
Serotype 6B Number Analyzed 275 participants 298 participants 281 participants
5.24
(4.68 to 5.86)
3.98
(3.52 to 4.51)
5.51
(4.90 to 6.20)
Serotype 7F Number Analyzed 274 participants 298 participants 282 participants
4.18
(3.76 to 4.64)
3.43
(3.14 to 3.75)
5.73
(5.24 to 6.28)
Serotype 9V Number Analyzed 273 participants 298 participants 281 participants
2.82
(2.52 to 3.15)
2.50
(2.28 to 2.75)
3.37
(3.04 to 3.72)
Serotype 14 Number Analyzed 275 participants 298 participants 282 participants
6.05
(5.37 to 6.82)
5.55
(4.99 to 6.17)
7.57
(6.81 to 8.42)
Serotype 18C Number Analyzed 275 participants 298 participants 281 participants
2.14
(1.94 to 2.37)
1.68
(1.54 to 1.83)
3.37
(3.06 to 3.71)
Serotype 19A Number Analyzed 275 participants 298 participants 281 participants
3.04
(2.72 to 3.40)
3.42
(3.03 to 3.87)
6.14
(5.57 to 6.78)
Serotype 19F Number Analyzed 275 participants 298 participants 282 participants
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) Number Analyzed 272 participants 298 participants 283 participants
9.64
(8.74 to 10.62)
7.73
(7.08 to 8.45)
0.12
(0.11 to 0.14)
Serotype 23F Number Analyzed 275 participants 298 participants 280 participants
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) Number Analyzed 273 participants 298 participants 283 participants
6.29
(5.62 to 7.05)
4.95
(4.46 to 5.51)
0.08
(0.08 to 0.09)
4.Primary Outcome
Title Number of Participants With an Adverse Event (AE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least one dose of study vaccination.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 368 382 376
Measure Type: Count of Participants
Unit of Measure: Participants
349
  94.8%
359
  94.0%
354
  94.1%
5.Primary Outcome
Title Number of Participants With an Injection-site AE
Hide Description Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Time Frame Up to Day 14 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least one dose of study vaccination.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 368 382 376
Measure Type: Count of Participants
Unit of Measure: Participants
307
  83.4%
302
  79.1%
304
  80.9%
6.Primary Outcome
Title Number of Participants With a Systemic AE
Hide Description Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Time Frame Up to Day 14 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 368 382 376
Measure Type: Count of Participants
Unit of Measure: Participants
342
  92.9%
352
  92.1%
347
  92.3%
7.Primary Outcome
Title Number of Participants With a Serious Adverse Event (SAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least one dose of study vaccination.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 368 382 376
Measure Type: Count of Participants
Unit of Measure: Participants
25
   6.8%
27
   7.1%
29
   7.7%
8.Primary Outcome
Title Number of Participants Who Discontinued the Study Due to an AE
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least one dose of study vaccination.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 368 382 376
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
1
   0.3%
2
   0.5%
9.Secondary Outcome
Title Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 120 120 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 120 participants 120 participants 121 participants
80.0
(71.7 to 86.7)
73.3
(64.5 to 81.0)
77.7
(69.2 to 84.8)
Serotype 3 Number Analyzed 120 participants 120 participants 122 participants
99.2
(95.4 to 100)
100.0
(97.0 to 100)
100.0
(97.0 to 100)
Serotype 4 Number Analyzed 120 participants 119 participants 121 participants
100.0
(97.0 to 100)
100.0
(96.9 to 100)
100.0
(97.0 to 100)
Serotype 5 Number Analyzed 120 participants 120 participants 122 participants
99.2
(95.4 to 100)
95.8
(90.5 to 98.6)
97.5
(93.0 to 99.5)
Serotype 6A Number Analyzed 120 participants 120 participants 122 participants
89.2
(82.2 to 94.1)
85.8
(78.3 to 91.5)
100.0
(97.0 to 100)
Serotype 6B Number Analyzed 119 participants 120 participants 121 participants
84.0
(76.2 to 90.1)
80.0
(71.7 to 86.7)
96.7
(91.8 to 99.1)
Serotype 7F Number Analyzed 120 participants 120 participants 122 participants
100.0
(97.0 to 100)
100.0
(97.0 to 100)
100.0
(97.0 to 100)
Serotype 9V Number Analyzed 120 participants 119 participants 122 participants
100.0
(97.0 to 100)
98.3
(94.1 to 100)
99.2
(95.5 to 100)
Serotype 14 Number Analyzed 120 participants 120 participants 122 participants
100.0
(97.0 to 100)
99.2
(95.4 to 100)
100.0
(97.0 to 100)
Serotype 18C Number Analyzed 120 participants 120 participants 122 participants
99.2
(95.4 to 100)
96.7
(91.7 to 99.1)
100.0
(97.0 to 100)
Serotype 19A Number Analyzed 120 participants 119 participants 122 participants
92.5
(86.2 to 96.5)
95.0
(89.3 to 98.1)
95.9
(90.7 to 98.7)
Serotype 19F Number Analyzed 120 participants 120 participants 122 participants
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) Number Analyzed 120 participants 120 participants 122 participants
99.2
(95.4 to 100)
100.0
(97.0 to 100)
11.6
(6.5 to 18.7)
Serotype 23F Number Analyzed 120 participants 119 participants 122 participants
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) Number Analyzed 120 participants 120 participants 122 participants
97.5
(92.9 to 99.5)
99.2
(95.4 to 100)
60.7
(51.4 to 69.4)
10.Secondary Outcome
Title Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 58 59 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
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)
11.Secondary Outcome
Title OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 120 120 122
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 1 Number Analyzed 120 participants 120 participants 121 participants
35.4
(25.4 to 49.3)
32.4
(22.5 to 46.5)
44.6
(31.2 to 63.7)
Serotype 3 Number Analyzed 120 participants 120 participants 122 participants
296.7
(246.9 to 356.6)
254.3
(215.9 to 299.6)
209.9
(178.6 to 246.7)
Serotype 4 Number Analyzed 120 participants 119 participants 121 participants
1672.9
(1414.3 to 1978.7)
1633.1
(1384.3 to 1926.6)
1911.6
(1608.0 to 2272.4)
Serotype 5 Number Analyzed 120 participants 120 participants 121 participants
467.6
(369.4 to 591.7)
337.0
(259.5 to 437.7)
542.8
(416.8 to 706.7)
Serotype 6A Number Analyzed 120 participants 120 participants 122 participants
1273.6
(807.3 to 2009.1)
703.3
(435.4 to 1136.1)
4009.7
(3316.0 to 4848.4)
Serotype 6B Number Analyzed 119 participants 120 participants 121 participants
765.5
(463.2 to 1265.2)
419.5
(244.8 to 719.0)
1597.5
(1145.7 to 2227.4)
Serotype 7F Number Analyzed 120 participants 120 participants 122 participants
5818.1
(4945.3 to 6844.8)
5791.3
(4816.9 to 6962.9)
10454.1
(8614.1 to 12687.0)
Serotype 9V Number Analyzed 120 participants 119 participants 122 participants
2227.4
(1791.0 to 2770.1)
1927.3
(1493.8 to 2486.5)
2685.5
(2110.5 to 3417.1)
Serotype 14 Number Analyzed 120 participants 120 participants 122 participants
2266.2
(1835.9 to 2797.2)
1574.8
(1232.4 to 2012.3)
2786.5
(2244.3 to 3459.7)
Serotype 18C Number Analyzed 120 participants 120 participants 122 participants
1263.7
(1035.4 to 1542.2)
846.6
(652.4 to 1098.8)
2209.0
(1833.1 to 2662.0)
Serotype 19A Number Analyzed 120 participants 119 participants 122 participants
551.7
(383.3 to 794.1)
457.9
(331.1 to 633.3)
1292.1
(921.9 to 1810.9)
Serotype 19F Number Analyzed 120 participants 120 participants 122 participants
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) Number Analyzed 120 participants 119 participants 122 participants
3048.8
(2484.3 to 3741.5)
2714.4
(2302.6 to 3199.9)
3.9
(2.8 to 5.5)
Serotype 23F Number Analyzed 120 participants 119 participants 122 participants
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) Number Analyzed 120 participants 120 participants 122 participants
25075.2
(16645.2 to 37774.5)
28262.3
(20745.0 to 38503.5)
66.6
(39.0 to 113.7)
12.Secondary Outcome
Title OPA GMTs as Measured by MOPA4 for Postvaccination 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 58 59 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
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)
13.Secondary Outcome
Title Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 300 315 315
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 275 participants 298 participants 283 participants
98.2
(95.8 to 99.4)
98.0
(95.7 to 99.3)
100.0
(98.7 to 100)
Serotype 3 Number Analyzed 272 participants 296 participants 282 participants
96.0
(92.9 to 98.0)
95.9
(93.0 to 97.9)
80.9
(75.8 to 85.3)
Serotype 4 Number Analyzed 274 participants 298 participants 281 participants
95.6
(92.5 to 97.7)
96.3
(93.5 to 98.1)
96.8
(94.0 to 98.5)
Serotype 5 Number Analyzed 275 participants 298 participants 282 participants
99.3
(97.4 to 100)
99.0
(97.1 to 100)
98.9
(96.9 to 100)
Serotype 6A Number Analyzed 274 participants 297 participants 279 participants
98.5
(96.3 to 100)
97.3
(94.8 to 98.8)
99.6
(98.0 to 100)
Serotype 6B Number Analyzed 275 participants 298 participants 281 participants
99.3
(97.4 to 100)
97.7
(95.2 to 99.1)
98.9
(96.9 to 100)
Serotype 7F Number Analyzed 274 participants 298 participants 282 participants
100.0
(98.7 to 100)
99.0
(97.1 to 100)
99.6
(98.0 to 100)
Serotype 9V Number Analyzed 273 participants 298 participants 281 participants
98.9
(96.8 to 100)
99.0
(97.1 to 100)
99.6
(98.0 to 100)
Serotype 14 Number Analyzed 275 participants 298 participants 282 participants
99.6
(98.0 to 100)
99.7
(98.1 to 100)
100.0
(98.7 to 100)
Serotype 18C Number Analyzed 275 participants 298 participants 281 participants
98.5
(96.3 to 100)
99.0
(97.1 to 100)
100.0
(98.7 to 100)
Serotype 19A Number Analyzed 275 participants 298 participants 281 participants
97.5
(94.8 to 99.0)
98.7
(96.6 to 100)
100.0
(98.7 to 100)
Serotype 19F Number Analyzed 275 participants 298 participants 282 participants
99.3
(97.4 to 100)
99.0
(97.1 to 100)
99.3
(97.5 to 100)
Serotype 22F (non-PREVNAR 13® serotype) Number Analyzed 272 participants 298 participants 283 participants
100.0
(98.7 to 100)
99.7
(98.1 to 100)
7.4
(4.7 to 11.1)
Serotype 23F Number Analyzed 275 participants 298 participants 280 participants
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) Number Analyzed 273 participants 298 participants 283 participants
98.9
(96.8 to 100)
98.3
(96.1 to 99.5)
4.9
(2.7 to 8.2)
14.Secondary Outcome
Title Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
Arm/Group Title V114 Adjuvanted V114 Nonadjuvanted PREVNAR 13®
Hide Arm/Group Description:
Participants received 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.
Participants received 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.
Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Number of Participants Analyzed 275 298 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 275 participants 298 participants 283 participants
77.5
(72.1 to 82.3)
76.5
(71.3 to 81.2)
84.1
(79.3 to 88.2)
Serotype 3 Number Analyzed 272 participants 296 participants 282 participants
63.6
(57.6 to 69.3)
56.8
(50.9 to 62.5)
30.9
(25.5 to 36.6)
Serotype 4 Number Analyzed 274 participants 298 participants 281 participants
62.0
(56.0 to 67.8)
65.1
(59.4 to 70.5)
73.3
(67.7 to 78.4)
Serotype 5 Number Analyzed 275 participants 298 participants 282 participants
79.6
(74.4 to 84.2)
75.8
(70.6 to 80.6)
85.1
(80.4 to 89.1)
Serotype 6A Number Analyzed 274 participants 297 participants 279 participants
89.8
(85.6 to 93.1)
89.2
(85.1 to 92.5)
97.5
(94.9 to 99.0)
Serotype 6B Number Analyzed 275 participants 298 participants 281 participants
97.1
(94.3 to 98.7)
92.6
(89.0 to 95.3)
95.4
(92.2 to 97.5)
Serotype 7F Number Analyzed 274 participants 298 participants 282 participants
96.4
(93.4 to 98.2)
97.0
(94.3 to 98.6)
99.3
(97.5 to 100)
Serotype 9V Number Analyzed 273 participants 298 participants 281 participants
88.6
(84.3 to 92.2)
87.9
(83.7 to 91.4)
91.5
(87.6 to 94.5)
Serotype 14 Number Analyzed 275 participants 298 participants 282 participants
95.3
(92.1 to 97.5)
97.0
(94.3 to 98.6)
98.2
(95.9 to 99.4)
Serotype 18C Number Analyzed 275 participants 298 participants 281 participants
83.6
(78.7 to 87.8)
74.5
(69.2 to 79.3)
95.0
(91.8 to 97.2)
Serotype 19A Number Analyzed 275 participants 298 participants 281 participants
87.6
(83.2 to 91.3)
87.9
(83.7 to 91.4)
96.4
(93.6 to 98.3)
Serotype 19F Number Analyzed 275 participants 298 participants 282 participants
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) Number Analyzed 272 participants 298 participants 283 participants
99.6
(98.0 to 100)
98.7
(96.6 to 100)
2.8
(1.2 to 5.5)
Serotype 23F Number Analyzed 275 participants 298 participants 280 participants
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) Number Analyzed 273 participants 298 participants 283 participants
96.0
(92.9 to 98.0)
96.6
(93.9 to 98.4)
1.4
(0 to 3.6)
Time Frame Up to 1 month after final vaccination
Adverse Event Reporting Description The safety population consisted of all randomized participants who received study vaccine.
 
Arm/Group Title V114 V114 Non-Adjuvanted Prevnar
Hide Arm/Group Description Participants received 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. Participants received 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. Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
All-Cause Mortality
V114 V114 Non-Adjuvanted Prevnar
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/368 (0.27%)      1/382 (0.26%)      2/376 (0.53%)    
Hide Serious Adverse Events
V114 V114 Non-Adjuvanted Prevnar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/368 (6.79%)      27/382 (7.07%)      29/376 (7.71%)    
Blood and lymphatic system disorders       
Neutropenia  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Congenital, familial and genetic disorders       
Pyloric stenosis  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Ileus  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
General disorders       
Developmental delay  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Pyrexia  1  0/368 (0.00%)  0 0/382 (0.00%)  0 2/376 (0.53%)  2
Sudden infant death syndrome  1  1/368 (0.27%)  1 0/382 (0.00%)  0 1/376 (0.27%)  1
Infections and infestations       
Bronchiolitis  1  5/368 (1.36%)  5 6/382 (1.57%)  6 4/376 (1.06%)  5
Bronchitis  1  0/368 (0.00%)  0 2/382 (0.52%)  4 0/376 (0.00%)  0
Cellulitis  1  1/368 (0.27%)  1 0/382 (0.00%)  0 3/376 (0.80%)  3
Croup infectious  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Gastritis viral  1  2/368 (0.54%)  2 0/382 (0.00%)  0 0/376 (0.00%)  0
Gastroenteritis  1  4/368 (1.09%)  4 1/382 (0.26%)  1 1/376 (0.27%)  1
Gastroenteritis viral  1  0/368 (0.00%)  0 1/382 (0.26%)  1 2/376 (0.53%)  2
Influenza  1  2/368 (0.54%)  2 1/382 (0.26%)  1 0/376 (0.00%)  0
Lobar pneumonia  1  2/368 (0.54%)  2 0/382 (0.00%)  0 0/376 (0.00%)  0
Meningitis  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Meningitis aseptic  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Metapneumovirus infection  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Otitis media  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Otitis media acute  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Periorbital cellulitis  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Pneumonia  1  2/368 (0.54%)  2 0/382 (0.00%)  0 2/376 (0.53%)  3
Pneumonia respiratory syncytial viral  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Pyelonephritis  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  6/368 (1.63%)  6 7/382 (1.83%)  7 6/376 (1.60%)  6
Skin candida  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Staphylococcal abscess  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Staphylococcal infection  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Subcutaneous abscess  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Upper respiratory tract infection  1  0/368 (0.00%)  0 2/382 (0.52%)  2 1/376 (0.27%)  1
Urinary tract infection  1  0/368 (0.00%)  0 1/382 (0.26%)  1 1/376 (0.27%)  1
Viral infection  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Nervous system disorders       
Convulsion  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Encephalitis  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Febrile convulsion  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Petit mal epilepsy  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Unresponsive to stimuli  1  1/368 (0.27%)  1 0/382 (0.00%)  0 0/376 (0.00%)  0
Psychiatric disorders       
Breath holding  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asphyxia  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
Bronchial hyperreactivity  1  0/368 (0.00%)  0 0/382 (0.00%)  0 1/376 (0.27%)  1
Respiratory distress  1  1/368 (0.27%)  1 1/382 (0.26%)  1 0/376 (0.00%)  0
Wheezing  1  0/368 (0.00%)  0 1/382 (0.26%)  1 0/376 (0.00%)  0
1
Term from vocabulary, MedDRA 15.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
V114 V114 Non-Adjuvanted Prevnar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   345/368 (93.75%)      348/382 (91.10%)      347/376 (92.29%)    
Gastrointestinal disorders       
Constipation  1  19/368 (5.16%)  19 3/382 (0.79%)  3 14/376 (3.72%)  15
Diarrhoea  1  36/368 (9.78%)  38 26/382 (6.81%)  29 36/376 (9.57%)  39
Vomiting  1  17/368 (4.62%)  20 25/382 (6.54%)  28 25/376 (6.65%)  27
General disorders       
Injection site erythema  1  217/368 (58.97%)  475 179/382 (46.86%)  348 201/376 (53.46%)  400
Injection site induration  1  163/368 (44.29%)  314 112/382 (29.32%)  180 160/376 (42.55%)  324
Injection site pain  1  264/368 (71.74%)  687 280/382 (73.30%)  632 271/376 (72.07%)  647
Injection site swelling  1  181/368 (49.18%)  378 132/382 (34.55%)  235 165/376 (43.88%)  332
Irritability  1  315/368 (85.60%)  1072 311/382 (81.41%)  1005 306/376 (81.38%)  988
Pyrexia  1  123/368 (33.42%)  197 86/382 (22.51%)  147 110/376 (29.26%)  186
Infections and infestations       
Nasopharyngitis  1  22/368 (5.98%)  22 22/382 (5.76%)  27 21/376 (5.59%)  22
Otitis media  1  29/368 (7.88%)  29 28/382 (7.33%)  28 22/376 (5.85%)  23
Upper respiratory tract infection  1  30/368 (8.15%)  32 41/382 (10.73%)  44 26/376 (6.91%)  32
Metabolism and nutrition disorders       
Decreased appetite  1  212/368 (57.61%)  492 195/382 (51.05%)  405 196/376 (52.13%)  397
Nervous system disorders       
Somnolence  1  263/368 (71.47%)  743 281/382 (73.56%)  756 265/376 (70.48%)  689
Respiratory, thoracic and mediastinal disorders       
Cough  1  28/368 (7.61%)  30 25/382 (6.54%)  28 19/376 (5.05%)  19
1
Term from vocabulary, MedDRA 15.0
Indicates events were collected by systematic assessment
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 SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01215188    
Other Study ID Numbers: V114-003
V114-003 ( Other Identifier: Merck Protocol Number )
First Submitted: October 4, 2010
First Posted: October 6, 2010
Results First Submitted: April 8, 2019
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019