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Trial record 3 of 15 for:    Completed Studies | Interventional Studies | Pneumococcal Infections | Poland | Child

Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024) (PNEU-PLAN)

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: NCT03885934
Recruitment Status : Completed
First Posted : March 22, 2019
Results First Posted : September 23, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Interventions Biological: V114
Biological: Prevnar 13®
Enrollment 606
Recruitment Details  
Pre-assignment Details A total of approximately 600 participants were planned for enrollment. Randomization was stratified by age and pneumococcal conjugate vaccine (PCV) history.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Period Title: Overall Study
Started 64 64 62 64 177 175
PCV Dose 1 64 64 62 64 177 175
PCV Dose 2 63 64 62 64 0 0
PCV Dose 3 63 64 0 0 0 0
Completed 63 64 62 64 177 175
Not Completed 1 0 0 0 0 0
Reason Not Completed
Withdrawn by Parent/Guardian             1             0             0             0             0             0
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years Total
Hide Arm/Group Description Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Total of all reporting groups
Overall Number of Baseline Participants 64 64 62 64 177 175 606
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 62 participants 64 participants 177 participants 175 participants 606 participants
7-11 Months
64
 100.0%
64
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
128
  21.1%
12-23 Months
0
   0.0%
0
   0.0%
62
 100.0%
64
 100.0%
0
   0.0%
0
   0.0%
126
  20.8%
≥2 to <6 Years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
114
  64.4%
112
  64.0%
226
  37.3%
≥6 to 17 Years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
63
  35.6%
63
  36.0%
126
  20.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 62 participants 64 participants 177 participants 175 participants 606 participants
Female
29
  45.3%
33
  51.6%
30
  48.4%
38
  59.4%
85
  48.0%
83
  47.4%
298
  49.2%
Male
35
  54.7%
31
  48.4%
32
  51.6%
26
  40.6%
92
  52.0%
92
  52.6%
308
  50.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 62 participants 64 participants 177 participants 175 participants 606 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
0
   0.0%
1
   0.2%
Not Hispanic or Latino
64
 100.0%
64
 100.0%
62
 100.0%
63
  98.4%
176
  99.4%
174
  99.4%
603
  99.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
1
   0.6%
2
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 62 participants 64 participants 177 participants 175 participants 606 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
53
  82.8%
53
  82.8%
52
  83.9%
53
  82.8%
60
  33.9%
56
  32.0%
327
  54.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
11
  17.2%
11
  17.2%
10
  16.1%
11
  17.2%
117
  66.1%
118
  67.4%
278
  45.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
1
   0.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Hide Description The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time Frame 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Overall Number of Participants Analyzed 64 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 1 Number Analyzed 60 participants 59 participants
2.47
(2.09 to 2.92)
3.66
(2.98 to 4.50)
Serotype 3 Number Analyzed 60 participants 59 participants
2.65
(2.30 to 3.05)
1.71
(1.40 to 2.08)
Serotype 4 Number Analyzed 60 participants 59 participants
2.21
(1.82 to 2.68)
3.85
(3.12 to 4.76)
Serotype 5 Number Analyzed 60 participants 59 participants
3.82
(3.14 to 4.63)
4.56
(3.58 to 5.80)
Serotype 6A Number Analyzed 60 participants 59 participants
2.23
(1.71 to 2.91)
4.30
(3.28 to 5.65)
Serotype 6B Number Analyzed 60 participants 59 participants
3.03
(2.41 to 3.82)
4.17
(3.25 to 5.36)
Serotype 7F Number Analyzed 60 participants 59 participants
5.16
(4.27 to 6.23)
6.42
(5.25 to 7.85)
Serotype 9V Number Analyzed 60 participants 59 participants
2.61
(2.09 to 3.26)
3.59
(2.86 to 4.51)
Serotype 14 Number Analyzed 60 participants 59 participants
9.62
(7.94 to 11.67)
13.07
(10.40 to 16.42)
Serotype 18C Number Analyzed 60 participants 59 participants
3.45
(2.80 to 4.24)
3.50
(2.75 to 4.45)
Serotype 19A Number Analyzed 60 participants 59 participants
4.59
(3.95 to 5.33)
5.81
(4.92 to 6.85)
Serotype 19F Number Analyzed 60 participants 59 participants
3.49
(2.94 to 4.15)
4.83
(4.03 to 5.79)
Serotype 23F Number Analyzed 60 participants 59 participants
2.62
(2.02 to 3.39)
2.79
(2.10 to 3.69)
Serotype 22F Number Analyzed 60 participants 58 participants
9.04
(7.48 to 10.93)
0.14
(0.10 to 0.19)
Serotype 33F Number Analyzed 60 participants 59 participants
3.37
(2.78 to 4.10)
0.13
(0.10 to 0.16)
2.Primary Outcome
Title GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Hide Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time Frame 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Overall Number of Participants Analyzed 62 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 1 Number Analyzed 56 participants 60 participants
3.83
(3.07 to 4.77)
4.20
(3.30 to 5.34)
Serotype 3 Number Analyzed 56 participants 60 participants
2.96
(2.44 to 3.58)
1.68
(1.29 to 2.20)
Serotype 4 Number Analyzed 56 participants 60 participants
3.46
(2.67 to 4.50)
4.89
(3.76 to 6.36)
Serotype 5 Number Analyzed 56 participants 60 participants
3.39
(2.65 to 4.34)
3.12
(2.52 to 3.88)
Serotype 6A Number Analyzed 56 participants 60 participants
2.05
(1.30 to 3.23)
3.73
(2.64 to 5.29)
Serotype 6B Number Analyzed 56 participants 60 participants
2.69
(1.70 to 4.25)
2.87
(1.92 to 4.30)
Serotype 7F Number Analyzed 56 participants 60 participants
4.80
(3.63 to 6.34)
5.42
(4.30 to 6.82)
Serotype 9V Number Analyzed 56 participants 60 participants
2.48
(1.97 to 3.11)
2.89
(2.21 to 3.78)
Serotype 14 Number Analyzed 56 participants 60 participants
8.23
(6.19 to 10.94)
8.30
(6.56 to 10.51)
Serotype 18C Number Analyzed 56 participants 60 participants
5.09
(3.98 to 6.52)
3.68
(2.85 to 4.75)
Serotype 19A Number Analyzed 56 participants 60 participants
6.74
(5.29 to 8.60)
5.87
(4.85 to 7.11)
Serotype 19F Number Analyzed 56 participants 60 participants
5.90
(4.69 to 7.43)
5.92
(4.93 to 7.11)
Serotype 23F Number Analyzed 56 participants 60 participants
2.85
(1.99 to 4.07)
2.18
(1.54 to 3.07)
Serotype 22F Number Analyzed 56 participants 60 participants
15.90
(12.16 to 20.78)
0.12
(0.09 to 0.16)
Serotype 33F Number Analyzed 56 participants 60 participants
5.17
(3.96 to 6.74)
0.15
(0.12 to 0.19)
3.Primary Outcome
Title GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Hide Description The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time Frame 30 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Overall Number of Participants Analyzed 177 175
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Serotype 1 Number Analyzed 162 participants 162 participants
3.00
(2.60 to 3.46)
3.99
(3.48 to 4.58)
Serotype 3 Number Analyzed 162 participants 162 participants
1.37
(1.19 to 1.58)
1.03
(0.88 to 1.21)
Serotype 4 Number Analyzed 162 participants 162 participants
2.53
(2.17 to 2.96)
5.22
(4.52 to 6.03)
Serotype 5 Number Analyzed 162 participants 162 participants
3.43
(2.89 to 4.07)
4.24
(3.46 to 5.20)
Serotype 6A Number Analyzed 162 participants 162 participants
9.03
(7.07 to 11.53)
8.81
(6.96 to 11.14)
Serotype 6B Number Analyzed 162 participants 161 participants
13.55
(10.52 to 17.46)
10.51
(8.01 to 13.78)
Serotype 7F Number Analyzed 162 participants 162 participants
4.03
(3.46 to 4.70)
4.63
(3.92 to 5.46)
Serotype 9V Number Analyzed 162 participants 162 participants
3.60
(3.06 to 4.24)
4.35
(3.65 to 5.20)
Serotype 14 Number Analyzed 162 participants 162 participants
9.21
(7.11 to 11.92)
8.04
(6.24 to 10.36)
Serotype 18C Number Analyzed 162 participants 162 participants
7.16
(6.03 to 8.52)
4.46
(3.76 to 5.30)
Serotype 19A Number Analyzed 162 participants 162 participants
10.99
(9.12 to 13.26)
14.90
(12.23 to 18.16)
Serotype 19F Number Analyzed 162 participants 162 participants
8.95
(7.45 to 10.76)
12.28
(10.07 to 14.97)
Serotype 23F Number Analyzed 162 participants 162 participants
5.36
(4.41 to 6.50)
5.12
(4.12 to 6.37)
Serotype 22F Number Analyzed 162 participants 159 participants
14.99
(12.73 to 17.66)
0.31
(0.24 to 0.38)
Serotype 33F Number Analyzed 162 participants 160 participants
4.89
(4.12 to 5.80)
0.27
(0.22 to 0.32)
4.Primary Outcome
Title Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Hide Description An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Time Frame Up to 14 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Redness/Erythema
28.1
(17.6 to 40.8)
34.4
(22.9 to 47.3)
Hardness/Induration
17.2
(8.9 to 28.7)
14.1
(6.6 to 25.0)
Pain
18.8
(10.1 to 30.5)
7.8
(2.6 to 17.3)
Swelling
18.8
(10.1 to 30.5)
15.6
(7.8 to 26.9)
5.Primary Outcome
Title Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Hide Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Time Frame Up to 14 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Overall Number of Participants Analyzed 62 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Redness/Erythema
21.0
(11.7 to 33.2)
21.9
(12.5 to 34.0)
Hardness/Induration
8.1
(2.7 to 17.8)
9.4
(3.5 to 19.3)
Pain
33.9
(22.3 to 47.0)
23.4
(13.8 to 35.7)
Swelling
14.5
(6.9 to 25.8)
12.5
(5.6 to 23.2)
6.Primary Outcome
Title Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Hide Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Time Frame Up to 14 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received 1 dose of study intervention.
Arm/Group Title V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Overall Number of Participants Analyzed 177 175
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Redness/Erythema
19.2
(13.7 to 25.8)
21.1
(15.3 to 27.9)
Hardness/Induration
6.8
(3.6 to 11.5)
14.9
(9.9 to 21.0)
Pain
54.8
(47.2 to 62.3)
56.6
(48.9 to 64.0)
Swelling
20.9
(15.2 to 27.6)
24.0
(17.9 to 31.0)
7.Primary Outcome
Title Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Hide Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Time Frame Up to 14 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Appetite lost/Decreased appetite
15.6
(7.8 to 26.9)
18.8
(10.1 to 30.5)
Irritability
32.8
(21.6 to 45.7)
43.8
(31.4 to 56.7)
Drowsiness/Somnolence
21.9
(12.5 to 34.0)
15.6
(7.8 to 26.9)
Hives or Welts/Urticaria
1.6
(0.0 to 8.4)
4.7
(1.0 to 13.1)
8.Primary Outcome
Title Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Hide Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Time Frame Up to 14 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Overall Number of Participants Analyzed 62 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Appetite lost/Decreased appetite
22.6
(12.9 to 35.0)
18.8
(10.1 to 30.5)
Irritability
35.5
(23.7 to 48.7)
21.9
(12.5 to 34.0)
Drowsiness/Somnolence
24.2
(14.2 to 36.7)
17.2
(8.9 to 28.7)
Hives or Welts/Urticaria
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
9.Primary Outcome
Title Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Hide Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Time Frame Up to 14 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received 1 dose of study intervention.
Arm/Group Title V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Overall Number of Participants Analyzed 177 175
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Joint pain/arthralgia
0.0
(0.0 to 2.1)
1.7
(0.4 to 4.9)
Appetite lost/Decreased appetite
2.3
(0.6 to 5.7)
2.9
(0.9 to 6.5)
Tiredness/Fatigue
15.8
(10.8 to 22.0)
17.1
(11.9 to 23.6)
Headache
11.9
(7.5 to 17.6)
13.7
(9.0 to 19.7)
Irritability
2.8
(0.9 to 6.5)
4.0
(1.6 to 8.1)
Muscle pain/Myalgia
23.7
(17.7 to 30.7)
16.6
(11.4 to 22.9)
Drowsiness/Somnolence
2.8
(0.9 to 6.5)
2.9
(0.9 to 6.5)
Hives or Welts/Urticaria
1.1
(0.1 to 4.0)
1.1
(0.1 to 4.1)
10.Primary Outcome
Title Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months
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. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Time Frame Up to ~6 months post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.0
(0.0 to 5.6)
0.0
(0.0 to 5.6)
11.Primary Outcome
Title Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months
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. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Time Frame Up to ~6 months post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Overall Number of Participants Analyzed 62 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.0
(0.0 to 5.8)
0.0
(0.0 to 5.6)
12.Primary Outcome
Title Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years
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. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
Time Frame Up to ~6 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who received at least 1 dose of study intervention.
Arm/Group Title V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Overall Number of Participants Analyzed 177 175
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0.0
(0.0 to 2.1)
0.0
(0.0 to 2.1)
13.Secondary Outcome
Title Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Hide Description Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Time Frame 30 days post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule A: Participants 7-11 Months Prevnar 13®, Schedule A: Participants 7-11 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 3 Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
96.6
(88.3 to 99.6)
Serotype 4 Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 5 Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 6A Number Analyzed 60 participants 59 participants
95.0
(86.1 to 99.0)
98.3
(90.9 to 100.0)
Serotype 6B Number Analyzed 60 participants 59 participants
96.7
(88.5 to 99.6)
100.0
(93.9 to 100.0)
Serotype 7F Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 9V Number Analyzed 60 participants 59 participants
98.3
(91.1 to 100.0)
100.0
(93.9 to 100.0)
Serotype 14 Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 18C Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 19A Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 19F Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
100.0
(93.9 to 100.0)
Serotype 23F Number Analyzed 60 participants 59 participants
98.3
(91.1 to 100.0)
100.0
(93.9 to 100.0)
Serotype 22F Number Analyzed 60 participants 58 participants
100.0
(94.0 to 100.0)
13.8
(6.1 to 25.4)
Serotype 33F Number Analyzed 60 participants 59 participants
100.0
(94.0 to 100.0)
11.9
(4.9 to 22.9)
14.Secondary Outcome
Title Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Hide Description Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Time Frame 30 days post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule B: Participants 12-23 Months Prevnar 13®, Schedule B: Participants 12-23 Months
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Overall Number of Participants Analyzed 62 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 56 participants 60 participants
100.0
(93.6 to 100.0)
98.3
(91.1 to 100.0)
Serotype 3 (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
90.0
(79.5 to 96.2)
Serotype 4 (n=56,60) Number Analyzed 56 participants 60 participants
100.0
(93.6 to 100.0)
96.7
(88.5 to 99.6)
Serotype 5 (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
98.3
(91.1 to 100.0)
Serotype 6A (n=56,60) Number Analyzed 56 participants 60 participants
83.9
(71.7 to 92.4)
95.0
(86.1 to 99.0)
Serotype 6B (n=56,60) Number Analyzed 56 participants 60 participants
89.3
(78.1 to 96.0)
88.3
(77.4 to 95.2)
Serotype 7F (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
100.0
(94.0 to 100.0)
Serotype 9V (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
96.7
(88.5 to 99.6)
Serotype 14 (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
100.0
(94.0 to 100.0)
Serotype 18C (n=56,60) Number Analyzed 56 participants 60 participants
96.4
(87.7 to 99.6)
98.3
(91.1 to 100.0)
Serotype 19A (n=56,60) Number Analyzed 56 participants 60 participants
98.2
(90.4 to 100.0)
100.0
(94.0 to 100.0)
Serotype 19F (n=56,60) Number Analyzed 56 participants 60 participants
100.0
(93.6 to 100.0)
100.0
(94.0 to 100.0)
Serotype 23F (n=56,60) Number Analyzed 56 participants 60 participants
94.6
(85.1 to 98.9)
88.3
(77.4 to 95.2)
Serotype 22F (n=56,60) Number Analyzed 56 participants 60 participants
100.0
(93.6 to 100.0)
6.7
(1.8 to 16.2)
Serotype 33F (n=56,60) Number Analyzed 56 participants 60 participants
94.6
(85.1 to 98.9)
15.0
(7.1 to 26.6)
15.Secondary Outcome
Title Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Hide Description Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Time Frame 30 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Arm/Group Title V114, Schedule C: Participants 2-17 Years Prevnar 13®, Schedule C: Participants 2-17 Years
Hide Arm/Group Description:
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Overall Number of Participants Analyzed 177 175
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Serotype 1 Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
100.0
(97.7 to 100.0)
Serotype 3 Number Analyzed 162 participants 162 participants
95.7
(91.3 to 98.2)
87.7
(81.6 to 92.3)
Serotype 4 Number Analyzed 162 participants 162 participants
98.8
(95.6 to 99.9)
100.0
(97.7 to 100.0)
Serotype 5 Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
99.4
(96.6 to 100.0)
Serotype 6A Number Analyzed 162 participants 162 participants
98.1
(94.7 to 99.6)
98.1
(94.7 to 99.6)
Serotype 6B Number Analyzed 162 participants 162 participants
98.1
(94.7 to 99.6)
96.9
(92.9 to 99.0)
Serotype 7F Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
100.0
(97.7 to 100.0)
Serotype 9V Number Analyzed 162 participants 162 participants
100.0
(97.7 to 100.0)
98.8
(95.6 to 99.9)
Serotype 14 Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
98.1
(94.7 to 99.6)
Serotype 18C Number Analyzed 162 participants 162 participants
100.0
(97.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 19A Number Analyzed 162 participants 162 participants
100.0
(97.7 to 100.0)
100.0
(97.7 to 100.0)
Serotype 19F Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
100.0
(97.7 to 100.0)
Serotype 23F Number Analyzed 162 participants 162 participants
99.4
(96.6 to 100.0)
95.7
(91.3 to 98.2)
Serotype 22F Number Analyzed 162 participants 159 participants
100.0
(97.7 to 100.0)
37.7
(30.2 to 45.8)
Serotype 33F Number Analyzed 162 participants 160 participants
99.4
(96.6 to 100.0)
37.5
(30.0 to 45.5)
Time Frame Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
Adverse Event Reporting Description The analysis population included all randomized participants who received at least 1 dose of study intervention.
 
Arm/Group Title V114 (7-11 Months) Prevnar (7-11 Months) V114 (12-23 Months) Prevnar (12-23 Months) V114 (2-17 Years) Prevnar (2-17 Years)
Hide Arm/Group Description Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
All-Cause Mortality
V114 (7-11 Months) Prevnar (7-11 Months) V114 (12-23 Months) Prevnar (12-23 Months) V114 (2-17 Years) Prevnar (2-17 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/64 (0.00%)      0/62 (0.00%)      0/64 (0.00%)      0/177 (0.00%)      0/175 (0.00%)    
Hide Serious Adverse Events
V114 (7-11 Months) Prevnar (7-11 Months) V114 (12-23 Months) Prevnar (12-23 Months) V114 (2-17 Years) Prevnar (2-17 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/64 (10.94%)      5/64 (7.81%)      4/62 (6.45%)      4/64 (6.25%)      4/177 (2.26%)      4/175 (2.29%)    
Infections and infestations             
Bronchiolitis  1  1/64 (1.56%)  1 1/64 (1.56%)  1 0/62 (0.00%)  0 1/64 (1.56%)  1 0/177 (0.00%)  0 0/175 (0.00%)  0
Croup infectious  1  1/64 (1.56%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Gastroenteritis  1  2/64 (3.13%)  2 0/64 (0.00%)  0 0/62 (0.00%)  0 1/64 (1.56%)  1 1/177 (0.56%)  1 1/175 (0.57%)  1
Gastroenteritis salmonella  1  1/64 (1.56%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Pharyngitis  1  1/64 (1.56%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 1/64 (1.56%)  1 0/177 (0.00%)  0 0/175 (0.00%)  0
Pneumonia bacterial  1  1/64 (1.56%)  1 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Exanthema subitum  1  0/64 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Tracheobronchitis  1  0/64 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Pneumonia respiratory syncytial viral  1  0/64 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Chikungunya virus infection  1  0/64 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Nasopharyngitis  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/64 (1.56%)  1 0/177 (0.00%)  0 0/175 (0.00%)  0
Pyelonephritis acute  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 1/64 (1.56%)  1 0/177 (0.00%)  0 0/175 (0.00%)  0
Influenza  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 1/177 (0.56%)  1 0/175 (0.00%)  0
Pneumonia  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 1/177 (0.56%)  1 1/175 (0.57%)  1
Tonsillitis  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 1/175 (0.57%)  1
Wound abscess  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 1/175 (0.57%)  1
Pneumonia viral  1  0/64 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Bacteraemia  1  0/64 (0.00%)  0 1/64 (1.56%)  1 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Gastroenteritis viral  1  0/64 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Tuberculosis  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 1/177 (0.56%)  1 0/175 (0.00%)  0
Injury, poisoning and procedural complications             
Limb injury  1  0/64 (0.00%)  0 0/64 (0.00%)  0 1/62 (1.61%)  1 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
Concussion  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 1/175 (0.57%)  1
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
V114 (7-11 Months) Prevnar (7-11 Months) V114 (12-23 Months) Prevnar (12-23 Months) V114 (2-17 Years) Prevnar (2-17 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/64 (68.75%)      47/64 (73.44%)      46/62 (74.19%)      36/64 (56.25%)      125/177 (70.62%)      125/175 (71.43%)    
Gastrointestinal disorders             
Diarrhoea  1  4/64 (6.25%)  4 3/64 (4.69%)  3 0/62 (0.00%)  0 0/64 (0.00%)  0 0/177 (0.00%)  0 0/175 (0.00%)  0
General disorders             
Injection site erythema  1  18/64 (28.13%)  29 22/64 (34.38%)  36 13/62 (20.97%)  14 14/64 (21.88%)  16 34/177 (19.21%)  37 37/175 (21.14%)  37
Injection site induration  1  11/64 (17.19%)  20 9/64 (14.06%)  16 5/62 (8.06%)  8 6/64 (9.38%)  9 12/177 (6.78%)  13 26/175 (14.86%)  28
Injection site swelling  1  12/64 (18.75%)  23 10/64 (15.63%)  17 9/62 (14.52%)  11 8/64 (12.50%)  8 37/177 (20.90%)  39 42/175 (24.00%)  43
Pyrexia  1  20/64 (31.25%)  26 14/64 (21.88%)  16 9/62 (14.52%)  11 7/64 (10.94%)  7 13/177 (7.34%)  14 13/175 (7.43%)  14
Injection site pain  1  12/64 (18.75%)  19 5/64 (7.81%)  6 21/62 (33.87%)  27 15/64 (23.44%)  17 97/177 (54.80%)  111 99/175 (56.57%)  106
Fatigue  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 28/177 (15.82%)  42 30/175 (17.14%)  38
Infections and infestations             
Nasopharyngitis  1  2/64 (3.13%)  2 6/64 (9.38%)  7 8/62 (12.90%)  11 7/64 (10.94%)  7 0/177 (0.00%)  0 0/175 (0.00%)  0
Upper respiratory tract infection  1  0/64 (0.00%)  0 0/64 (0.00%)  0 4/62 (6.45%)  5 1/64 (1.56%)  1 0/177 (0.00%)  0 0/175 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  10/64 (15.63%)  15 12/64 (18.75%)  17 14/62 (22.58%)  21 12/64 (18.75%)  19 0/177 (0.00%)  0 0/175 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Myalgia  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 42/177 (23.73%)  46 30/175 (17.14%)  34
Nervous system disorders             
Somnolence  1  14/64 (21.88%)  22 10/64 (15.63%)  15 15/62 (24.19%)  29 11/64 (17.19%)  11 0/177 (0.00%)  0 0/175 (0.00%)  0
Headache  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/62 (0.00%)  0 0/64 (0.00%)  0 21/177 (11.86%)  32 24/175 (13.71%)  33
Psychiatric disorders             
Irritability  1  21/64 (32.81%)  39 28/64 (43.75%)  41 22/62 (35.48%)  33 14/64 (21.88%)  18 0/177 (0.00%)  0 0/175 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
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.
If publication activity is not directed by the Sponsor, 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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03885934    
Other Study ID Numbers: V114-024
2018-003706-88 ( EudraCT Number )
First Submitted: March 20, 2019
First Posted: March 22, 2019
Results First Submitted: August 26, 2021
Results First Posted: September 23, 2021
Last Update Posted: September 23, 2021