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Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

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ClinicalTrials.gov Identifier: NCT00962780
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Pneumococcal Infections
Interventions Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Procedure: Blood draw
Enrollment 303
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants)
Hide Arm/Group Description Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose). Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Period Title: Overall Study
Started 151 152
Vaccinated 13vPnC Dose 1 150 151
Vaccinated 13vPnC Dose 2 145 145
Vaccinated 13vPnC Dose 3 144 142
Vaccinated 23vPS Dose 143 139
Completed 141 138
Not Completed 10 14
Reason Not Completed
Death             0             1
Protocol Violation             9             4
Withdrawal by Subject             1             8
Other             0             1
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) Total
Hide Arm/Group Description Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose). Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose). Total of all reporting groups
Overall Number of Baseline Participants 150 151 301
Hide Baseline Analysis Population Description
Safety population included all enrolled participants who received at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 151 participants 301 participants
10.3  (3.04) 41.2  (8.45) 25.8  (16.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 participants
Female
76
  50.7%
88
  58.3%
164
  54.5%
Male
74
  49.3%
63
  41.7%
137
  45.5%
1.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time Frame 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.
Arm/Group Title 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 259
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 248)
1.03
(0.99 to 1.07)
Serotype 3 (n = 238)
1.05
(1.00 to 1.10)
Serotype 4 (n = 257)
1.09
(1.03 to 1.14)
Serotype 5 (n = 257)
1.01
(0.97 to 1.05)
Serotype 6A (n = 249)
1.02
(0.97 to 1.07)
Serotype 6B (n = 257)
1.04
(1.01 to 1.08)
Serotype 7F (n = 259)
1.10
(1.05 to 1.16)
Serotype 9V (n = 259)
1.05
(1.01 to 1.09)
Serotype 14 (n = 259)
1.04
(1.00 to 1.09)
Serotype 18C (n = 259)
0.99
(0.96 to 1.02)
Serotype 19A (n = 259)
0.99
(0.96 to 1.03)
Serotype 19F (n = 252)
1.06
(1.01 to 1.11)
Serotype 23F (n = 258)
1.09
(1.03 to 1.15)
2.Secondary Outcome
Title Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Hide Description Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies all participants who were evaluable for this measure and "n" signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 128 131 259
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter (mcg/mL)
Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248)
3.88
(3.30 to 4.57)
3.95
(3.23 to 4.85)
3.92
(3.44 to 4.46)
Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248)
4.14
(3.56 to 4.83)
3.92
(3.21 to 4.79)
4.03
(3.55 to 4.57)
Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238)
1.47
(1.25 to 1.74)
0.97
(0.81 to 1.16)
1.19
(1.05 to 1.35)
Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238)
1.49
(1.26 to 1.76)
1.06
(0.88 to 1.27)
1.25
(1.11 to 1.42)
Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257)
3.06
(2.54 to 3.69)
2.97
(2.40 to 3.67)
3.01
(2.62 to 3.47)
Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257)
3.36
(2.84 to 3.97)
3.19
(2.59 to 3.91)
3.27
(2.87 to 3.73)
Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257)
4.52
(3.78 to 5.39)
5.77
(4.83 to 6.89)
5.12
(4.51 to 5.80)
Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257)
4.84
(4.12 to 5.70)
5.53
(4.63 to 6.61)
5.18
(4.60 to 5.85)
Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249)
7.66
(6.46 to 9.08)
7.03
(5.71 to 8.67)
7.33
(6.40 to 8.39)
Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249)
7.97
(6.81 to 9.33)
7.04
(5.74 to 8.64)
7.47
(6.56 to 8.51)
Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257)
11.43
(9.45 to 13.84)
7.93
(6.51 to 9.65)
9.50
(8.28 to 10.91)
Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257)
11.94
(10.01 to 14.24)
8.28
(6.78 to 10.11)
9.92
(8.67 to 11.35)
Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259)
4.25
(3.67 to 4.92)
5.78
(4.81 to 6.95)
4.96
(4.41 to 5.59)
Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259)
5.05
(4.38 to 5.82)
5.90
(4.95 to 7.04)
5.46
(4.88 to 6.12)
Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259)
4.81
(4.18 to 5.54)
5.14
(4.27 to 6.19)
4.98
(4.43 to 5.59)
Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259)
4.98
(4.35 to 5.70)
5.48
(4.59 to 6.55)
5.23
(4.67 to 5.84)
Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259)
11.60
(8.76 to 15.35)
15.14
(11.64 to 19.71)
13.27
(10.96 to 16.08)
Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259)
12.62
(9.75 to 16.33)
15.13
(11.80 to 19.40)
13.83
(11.57 to 16.53)
Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259)
3.79
(3.12 to 4.60)
5.33
(4.34 to 6.54)
4.50
(3.91 to 5.19)
Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259)
3.83
(3.19 to 4.60)
5.18
(4.27 to 6.28)
4.46
(3.90 to 5.10)
Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259)
14.38
(12.20 to 16.96)
13.19
(11.06 to 15.75)
13.77
(12.21 to 15.53)
Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259)
14.19
(12.17 to 16.54)
13.18
(11.11 to 15.62)
13.67
(12.20 to 15.32)
Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252)
5.78
(4.63 to 7.21)
5.34
(4.17 to 6.84)
5.55
(4.71 to 6.55)
Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252)
6.09
(4.98 to 7.44)
5.67
(4.47 to 7.18)
5.87
(5.03 to 6.85)
Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258)
6.45
(5.30 to 7.85)
6.10
(4.86 to 7.66)
6.27
(5.40 to 7.28)
Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258)
6.64
(5.55 to 7.94)
7.06
(5.65 to 8.82)
6.85
(5.94 to 7.90)
3.Secondary Outcome
Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Hide Description Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 127 129 256
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253)
51
(37.2 to 70.0)
54
(38.7 to 74.2)
52
(41.8 to 65.5)
Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253)
69
(51.6 to 91.4)
69
(51.3 to 92.0)
69
(56.1 to 84.1)
Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256)
81
(64.1 to 102.0)
48
(37.9 to 61.5)
62
(52.6 to 73.9)
Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256)
114
(94.5 to 137.8)
79
(62.1 to 99.9)
95
(81.3 to 110.3)
Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243)
2509
(1922.3 to 3274.2)
1620
(1211.2 to 2167.4)
2000
(1639.8 to 2439.1)
Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243)
3246
(2697.1 to 3906.3)
1944
(1465.3 to 2579.7)
2488
(2092.1 to 2959.8)
Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246)
159
(109.2 to 232.2)
104
(69.1 to 156.9)
129
(97.3 to 169.7)
Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246)
267
(191.3 to 371.5)
142
(97.5 to 206.7)
194
(150.8 to 249.7)
Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249)
5560
(4378.4 to 7060.9)
2425
(1790.7 to 3284.5)
3678
(3016.2 to 4485.6)
Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249)
7758
(6314.2 to 9531.2)
3239
(2488.5 to 4215.9)
5022
(4216.8 to 5979.9)
Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249)
5449
(4365.1 to 6801.1)
2724
(2004.8 to 3701.0)
3815
(3140.9 to 4634.1)
Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249)
7151
(5828.2 to 8773.9)
3723
(2771.1 to 5002.5)
5113
(4250.1 to 6150.5)
Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252)
3494
(2772.8 to 4403.3)
2255
(1739.6 to 2923.6)
2802
(2352.6 to 3338.0)
Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252)
4638
(3889.7 to 5529.4)
2702
(2130.3 to 3428.2)
3533
(3037.4 to 4108.5)
Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245)
3339
(2461.4 to 4530.3)
1432
(998.6 to 2054.9)
2153
(1690.3 to 2743.3)
Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245)
4714
(3731.5 to 5955.4)
2004
(1416.5 to 2836.1)
3026
(2434.3 to 3761.4)
Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244)
3704
(2906.5 to 4719.5)
1342
(1010.1 to 1782.1)
2183
(1792.2 to 2659.6)
Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244)
3963
(3195.8 to 4914.2)
1480
(1150.3 to 1903.9)
2373
(1988.4 to 2832.8)
Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238)
4635
(3609.7 to 5951.8)
1349
(947.0 to 1921.5)
2475
(1965.7 to 3115.4)
Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238)
5579
(4423.7 to 7036.9)
1787
(1272.8 to 2508.5)
3127
(2515.2 to 3888.6)
Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252)
684
(519.2 to 902.1)
458
(332.5 to 631.2)
559
(452.3 to 690.9)
Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252)
1002
(814.5 to 1232.3)
613
(465.6 to 806.4)
782
(657.2 to 930.5)
Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240)
717
(495.6 to 1036.7)
315
(196.7 to 506.0)
479
(354.4 to 646.9)
Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240)
1152
(864.2 to 1535.0)
597
(397.9 to 897.1)
834
(650.1 to 1070.2)
Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246)
1477
(1086.2 to 2008.2)
409
(271.9 to 614.0)
765
(585.2 to 999.4)
Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246)
2327
(1844.2 to 2935.9)
671
(449.8 to 1000.3)
1231
(963.0 to 1572.5)
4.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time Frame 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 127 129 256
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 126, 127, 253)
1.3
(1.13 to 1.61)
1.3
(1.09 to 1.51)
1.3
(1.16 to 1.48)
Serotype 3 (n = 127, 129, 256)
1.4
(1.25 to 1.59)
1.6
(1.45 to 1.83)
1.5
(1.40 to 1.65)
Serotype 4 (n = 117, 126, 243)
1.3
(1.10 to 1.52)
1.2
(1.07 to 1.34)
1.2
(1.13 to 1.37)
Serotype 5 (n = 122, 124, 246)
1.7
(1.36 to 2.06)
1.4
(1.17 to 1.59)
1.5
(1.33 to 1.72)
Serotype 6A (n = 125, 124, 249)
1.4
(1.22 to 1.60)
1.3
(1.15 to 1.55)
1.4
(1.23 to 1.51)
Serotype 6B (n = 121, 128, 249)
1.3
(1.18 to 1.46)
1.4
(1.20 to 1.56)
1.3
(1.23 to 1.46)
Serotype 7F (n = 125, 127, 252)
1.3
(1.15 to 1.53)
1.2
(1.03 to 1.40)
1.3
(1.14 to 1.40)
Serotype 9V (n = 118, 127, 245)
1.4
(1.16 to 1.72)
1.4
(1.18 to 1.65)
1.4
(1.24 to 1.60)
Serotype 14 (n = 117, 127, 244)
1.1
(0.95 to 1.20)
1.1
(0.98 to 1.24)
1.1
(1.00 to 1.18)
Serotype 18C (n = 117, 121, 238)
1.2
(1.10 to 1.32)
1.3
(1.08 to 1.63)
1.3
(1.13 to 1.42)
Serotype 19A (n = 125, 127, 252)
1.5
(1.27 to 1.68)
1.3
(1.18 to 1.52)
1.4
(1.27 to 1.54)
Serotype 19F (n = 122, 118, 240)
1.6
(1.31 to 1.97)
1.9
(1.45 to 2.48)
1.7
(1.48 to 2.06)
Serotype 23F (n = 120, 126, 246)
1.6
(1.31 to 1.90)
1.6
(1.34 to 2.02)
1.6
(1.40 to 1.85)
5.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Time Frame 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 128 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 120, 128)
1.07
(1.01 to 1.13)
0.99
(0.93 to 1.06)
Serotype 3 (n = 118, 120)
1.01
(0.95 to 1.08)
1.09
(1.02 to 1.16)
Serotype 4 (n = 127, 130)
1.10
(1.02 to 1.18)
1.07
(1.00 to 1.16)
Serotype 5 (n = 126, 131)
1.07
(1.01 to 1.14)
0.96
(0.91 to 1.01)
Serotype 6A (n = 119, 130)
1.04
(0.96 to 1.12)
1.00
(0.95 to 1.06)
Serotype 6B (n = 127, 130)
1.04
(0.99 to 1.10)
1.04
(0.99 to 1.11)
Serotype 7F (n = 128, 131)
1.19
(1.12 to 1.27)
1.02
(0.95 to 1.10)
Serotype 9V (n = 128, 131)
1.03
(0.98 to 1.09)
1.07
(1.02 to 1.12)
Serotype 14 (n = 128, 131)
1.09
(1.02 to 1.16)
1.00
(0.95 to 1.05)
Serotype 18C (n = 128, 131)
1.01
(0.96 to 1.07)
0.97
(0.93 to 1.01)
Serotype 19A (n = 128, 131)
0.99
(0.93 to 1.04)
1.00
(0.96 to 1.04)
Serotype 19F (n = 124, 128)
1.05
(0.98 to 1.13)
1.06
(0.99 to 1.14)
Serotype 23F (n = 127, 131)
1.03
(0.96 to 1.11)
1.16
(1.07 to 1.26)
6.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Hide Description Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 133 137 270
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Serotype 1: Before 13vPnC Dose 1 (n=78,122,200)
1.03
(0.72 to 1.48)
0.82
(0.63 to 1.06)
0.90
(0.73 to 1.10)
Serotype 1: After 13vPnC Dose 1 (n=78,122,200)
3.78
(2.97 to 4.80)
4.00
(3.19 to 5.01)
3.91
(3.32 to 4.61)
Serotype 3: Before 13vPnC Dose 1 (n=99,127,226)
0.83
(0.62 to 1.11)
0.47
(0.37 to 0.58)
0.60
(0.50 to 0.72)
Serotype 3: After 13vPnC Dose 1 (n=99,127,226)
1.25
(0.99 to 1.58)
0.75
(0.62 to 0.92)
0.94
(0.81 to 1.09)
Serotype 4: Before 13vPnC Dose 1 (n=95,127,222)
0.19
(0.14 to 0.25)
0.35
(0.28 to 0.45)
0.27
(0.22 to 0.33)
Serotype 4: After 13vPnC Dose 1 (n=95,127,222)
2.62
(1.97 to 3.50)
2.91
(2.26 to 3.75)
2.79
(2.31 to 3.36)
Serotype 5: Before 13vPnC Dose 1 (n=122,137,259)
4.18
(3.42 to 5.12)
3.38
(2.84 to 4.02)
3.74
(3.28 to 4.27)
Serotype 5: After 13vPnC Dose 1 (n=122,137,259)
4.81
(3.98 to 5.80)
5.53
(4.63 to 6.61)
5.18
(4.55 to 5.89)
Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235)
6.22
(5.19 to 7.45)
2.67
(2.24 to 3.18)
3.81
(3.32 to 4.37)
Serotype 6A: After 13vPnC Dose 1 (n=99,136,235)
7.31
(6.07 to 8.79)
6.77
(5.38 to 8.51)
6.99
(6.00 to 8.15)
Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265)
5.52
(4.59 to 6.64)
3.23
(2.69 to 3.88)
4.21
(3.69 to 4.81)
Serotype 6B: After 13vPnC Dose 1 (n=131,134,265)
10.26
(8.37 to 12.58)
7.29
(5.81 to 9.15)
8.63
(7.41 to 10.06)
Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245)
0.85
(0.63 to 1.14)
1.14
(0.94 to 1.37)
1.00
(0.84 to 1.18)
Serotype 7F: After 13vPnC Dose 1 (n=111,134,245)
4.34
(3.68 to 5.11)
5.57
(4.57 to 6.78)
4.97
(4.36 to 5.67)
Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266)
2.10
(1.74 to 2.54)
1.56
(1.30 to 1.86)
1.80
(1.58 to 2.05)
Serotype 9V: After 13vPnC Dose 1 (n=129,137,266)
4.77
(4.08 to 5.57)
5.16
(4.24 to 6.27)
4.97
(4.38 to 5.63)
Serotype 14: Before 13vPnC Dose 1 (n=113,136,249)
0.76
(0.57 to 1.03)
2.45
(1.94 to 3.09)
1.44
(1.18 to 1.76)
Serotype 14: After 13vPnC Dose 1 (n=113,136,249)
12.04
(8.48 to 17.10)
16.46
(12.38 to 21.90)
14.28
(11.44 to 17.84)
Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261)
0.66
(0.52 to 0.85)
0.85
(0.69 to 1.04)
0.75
(0.64 to 0.88)
Serotype 18C: After 13vPnC Dose 1 (n=127,134,261)
3.92
(3.14 to 4.91)
5.55
(4.51 to 6.84)
4.69
(4.02 to 5.46)
Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270)
7.51
(6.34 to 8.90)
4.78
(4.04 to 5.66)
5.97
(5.29 to 6.74)
Serotype 19A: After 13vPnC Dose 1 (n=133,137,270)
13.28
(11.11 to 15.87)
13.03
(10.75 to 15.80)
13.15
(11.54 to 14.99)
Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219)
1.36
(1.06 to 1.75)
1.36
(1.07 to 1.73)
1.36
(1.14 to 1.62)
Serotype 19F: After 13vPnC Dose 1 (n=93,126,219)
4.62
(3.55 to 6.02)
4.98
(3.74 to 6.62)
4.82
(3.96 to 5.88)
Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263)
2.29
(1.83 to 2.86)
1.61
(1.31 to 1.96)
1.90
(1.64 to 2.21)
Serotype 23F: After 13vPnC Dose 1 (n=126,137,263)
5.65
(4.66 to 6.86)
5.30
(4.16 to 6.75)
5.47
(4.68 to 6.39)
7.Other Pre-specified Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Time Frame Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 133 137 270
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 78, 122, 200)
3.67
(2.70 to 4.99)
4.88
(3.87 to 6.15)
4.37
(3.63 to 5.25)
Serotype 3 (n = 99, 127, 226)
1.51
(1.27 to 1.79)
1.62
(1.43 to 1.83)
1.57
(1.42 to 1.74)
Serotype 4 (n = 95, 127, 222)
14.02
(10.55 to 18.62)
8.29
(6.55 to 10.49)
10.38
(8.64 to 12.47)
Serotype 5 (n = 122, 137, 259)
1.15
(1.06 to 1.25)
1.64
(1.44 to 1.85)
1.38
(1.28 to 1.50)
Serotype 6A (n = 99, 136, 235)
1.18
(1.02 to 1.35)
2.54
(2.09 to 3.07)
1.83
(1.60 to 2.10)
Serotype 6B (n = 131, 134, 265)
1.86
(1.55 to 2.22)
2.26
(1.87 to 2.72)
2.05
(1.80 to 2.33)
Serotype 7F (n = 111, 134, 245)
5.11
(3.92 to 6.65)
4.90
(3.99 to 6.03)
4.99
(4.24 to 5.88)
Serotype 9V (n = 129, 137, 266)
2.27
(1.97 to 2.61)
3.32
(2.76 to 3.99)
2.76
(2.45 to 3.10)
Serotype 14 (n = 113, 136, 249)
15.79
(11.84 to 21.05)
6.73
(5.17 to 8.76)
9.91
(8.11 to 12.11)
Serotype 18C (n = 127, 134, 261)
5.92
(4.64 to 7.55)
6.55
(5.23 to 8.20)
6.23
(5.29 to 7.35)
Serotype 19A (n = 133, 137, 270)
1.77
(1.55 to 2.02)
2.73
(2.31 to 3.21)
2.20
(1.98 to 2.45)
Serotype 19F (n = 93, 126, 219)
3.39
(2.71 to 4.25)
3.66
(2.96 to 4.52)
3.54
(3.04 to 4.13)
Serotype 23F (n = 126, 137, 263)
2.47
(2.02 to 3.02)
3.30
(2.71 to 4.03)
2.87
(2.49 to 3.31)
8.Other Pre-specified Outcome
Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Hide Description Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 129 128 257
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Serotype 1: Before 13vPnC Dose 1 (n=129,127,256)
5
(4.3 to 5.8)
5
(4.3 to 5.2)
5
(4.4 to 5.3)
Serotype 1: After 13vPnC Dose 1 (n=129,127,256)
49
(35.3 to 68.1)
57
(41.6 to 79.3)
53
(42.2 to 66.7)
Serotype 3: Before 13vPnC Dose 1 (n=126,128,254)
8
(6.6 to 10.8)
5
(4.5 to 5.8)
7
(5.7 to 7.5)
Serotype 3: After 13vPnC Dose 1 (n=126,128,254)
41
(31.7 to 52.6)
21
(16.3 to 27.1)
29
(24.3 to 35.1)
Serotype 4: Before 13vPnC Dose 1 (n=108,119,227)
25
(15.2 to 41.7)
27
(17.0 to 42.1)
26
(18.6 to 36.3)
Serotype 4: After 13vPnC Dose 1 (n=108,119,227)
2247
(1611.9 to 3131.4)
1372
(958.8 to 1963.7)
1735
(1356.9 to 2218.3)
Serotype 5: Before 13vPnC Dose 1 (n=125,122,247)
5
(4.5 to 6.7)
6
(4.8 to 6.8)
6
(4.9 to 6.4)
Serotype 5: After 13vPnC Dose 1 (n=125,122,247)
79
(52.5 to 118.0)
123
(81.8 to 186.3)
98
(73.7 to 131.1)
Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197)
157
(84.4 to 292.5)
61
(35.1 to 106.8)
98
(64.6 to 149.4)
Serotype 6A: After 13vPnC Dose 1 (n=99,98,197)
3480
(2460.1 to 4921.8)
1543
(984.4 to 2418.5)
2322
(1743.1 to 3092.9)
Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221)
279
(155.5 to 501.1)
231
(143.4 to 372.5)
252
(174.1 to 364.6)
Serotype 6B: After 13vPnC Dose 1 (n=101,120,221)
3852
(2888.3 to 5137.8)
2099
(1455.6 to 3028.2)
2771
(2179.2 to 3522.5)
Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223)
416
(253.5 to 682.9)
38
(22.9 to 64.6)
124
(84.3 to 183.8)
Serotype 7F: After 13vPnC Dose 1 (n=110,113,223)
3775
(3019.4 to 4720.1)
2005
(1443.9 to 2783.1)
2739
(2237.5 to 3353.5)
Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226)
152
(87.2 to 266.2)
69
(40.7 to 117.2)
101
(68.8 to 148.6)
Serotype 9V: After 13vPnC Dose 1 (n=109,117,226)
2533
(1822.7 to 3520.3)
1231
(836.1 to 1812.2)
1743
(1347.0 to 2256.4)
Serotype 14: Before 13vPnC Dose 1 (n=107,126,233)
328
(201.4 to 535.5)
123
(79.6 to 191.4)
193
(139.0 to 269.2)
Serotype 14: After 13vPnC Dose 1 (n=107,126,233)
3571
(2772.2 to 4600.1)
1277
(944.9 to 1725.8)
2048
(1660.8 to 2524.9)
Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215)
42
(21.9 to 79.0)
25
(15.5 to 39.6)
31
(21.2 to 45.8)
Serotype 18C: After 13vPnC Dose 1 (n=95,120,215)
2821
(1891.1 to 4208.9)
1031
(671.3 to 1584.6)
1609
(1188.2 to 2178.5)
Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257)
28
(19.1 to 40.8)
23
(16.7 to 32.7)
26
(19.9 to 32.9)
Serotype 19A: After 13vPnC Dose 1 (n=129,128,257)
506
(381.9 to 671.7)
390
(275.2 to 552.8)
445
(355.7 to 555.9)
Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246)
11
(7.6 to 15.5)
14
(9.5 to 20.1)
12
(9.5 to 15.8)
Serotype 19F: After 13vPnC Dose 1 (n=123,123,246)
425
(285.3 to 632.5)
214
(130.4 to 352.3)
302
(219.3 to 415.2)
Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243)
14
(9.3 to 22.0)
7
(5.3 to 9.0)
10
(7.6 to 12.7)
Serotype 23F: After 13vPnC Dose 1 (n=118,125,243)
587
(379.3 to 907.7)
140
(86.6 to 227.6)
281
(200.8 to 393.7)
9.Other Pre-specified Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Time Frame Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 129 128 257
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 129, 127, 256)
9.8
(6.97 to 13.81)
12.2
(8.84 to 16.84)
10.9
(8.65 to 13.81)
Serotype 3 (n = 126, 128, 254)
4.8
(3.72 to 6.30)
4.1
(3.22 to 5.30)
4.5
(3.73 to 5.35)
Serotype 4 (n = 108, 119, 227)
89.4
(51.43 to 155.31)
51.3
(31.16 to 84.59)
66.8
(46.17 to 96.75)
Serotype 5 (n = 125, 122, 247)
14.4
(9.56 to 21.67)
21.7
(14.55 to 32.32)
17.6
(13.25 to 23.44)
Serotype 6A (n = 99, 98, 197)
22.2
(12.61 to 38.90)
25.2
(14.51 to 43.83)
23.6
(15.98 to 34.94)
Serotype 6B (n = 101, 120, 221)
13.8
(8.12 to 23.45)
9.1
(5.91 to 13.95)
11.0
(7.87 to 15.37)
Serotype 7F (n = 110, 113, 223)
9.1
(5.79 to 14.23)
52.2
(31.42 to 86.57)
22.0
(15.42 to 31.42)
Serotype 9V (n = 109, 117, 226)
16.6
(9.71 to 28.47)
17.8
(10.53 to 30.18)
17.2
(11.87 to 25.04)
Serotype 14 (n = 107, 126, 233)
10.9
(6.79 to 17.41)
10.3
(6.82 to 15.70)
10.6
(7.76 to 14.44)
Serotype 18C (n = 95, 120, 215)
67.9
(35.25 to 130.73)
41.6
(24.59 to 70.26)
51.6
(34.27 to 77.78)
Serotype 19A (n = 129, 128, 257)
18.1
(12.52 to 26.25)
16.7
(11.78 to 23.61)
17.4
(13.51 to 22.38)
Serotype 19F (n = 123, 123, 246)
39.0
(24.56 to 62.05)
15.5
(9.77 to 24.65)
24.6
(17.69 to 34.25)
Serotype 23F (n = 118, 125, 243)
41.1
(24.94 to 67.81)
20.2
(12.78 to 32.05)
28.6
(20.34 to 40.10)
10.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Hide Description Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 133 130 263
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Serotype 1: After 13vPnC Dose 3 (n=128,127,255)
4.08
(3.53 to 4.73)
3.94
(3.22 to 4.82)
4.01
(3.54 to 4.54)
Serotype 1: After 23vPS Dose (n=128,127,255)
4.42
(3.80 to 5.14)
4.02
(3.32 to 4.85)
4.21
(3.74 to 4.75)
Serotype 3: After 13vPnC Dose 3 (n=124,118,242)
1.49
(1.27 to 1.75)
1.04
(0.87 to 1.26)
1.25
(1.11 to 1.42)
Serotype 3: After 23vPS Dose (n=124,118,242)
1.65
(1.42 to 1.92)
0.98
(0.82 to 1.17)
1.28
(1.14 to 1.44)
Serotype 4: After 13vPnC Dose 3 (n=133,128,261)
3.29
(2.79 to 3.87)
3.19
(2.59 to 3.93)
3.24
(2.84 to 3.70)
Serotype 4: After 23vPS Dose (n=133,128,261)
3.28
(2.77 to 3.88)
3.01
(2.44 to 3.72)
3.15
(2.75 to 3.59)
Serotype 5: After 13vPnC Dose 3 (n=132,130,262)
4.73
(4.02 to 5.57)
5.54
(4.64 to 6.63)
5.12
(4.54 to 5.78)
Serotype 5: After 23vPS Dose (n=132,130,262)
5.08
(4.33 to 5.95)
6.20
(5.23 to 7.35)
5.61
(4.99 to 6.30)
Serotype 6A: After 13vPnC Dose 3 (n=122,129,251)
8.20
(6.99 to 9.61)
7.07
(5.75 to 8.69)
7.60
(6.67 to 8.66)
Serotype 6A: After 23vPS Dose (n=122,129,251)
7.98
(6.85 to 9.31)
6.71
(5.51 to 8.17)
7.30
(6.44 to 8.27)
Serotype 6B: After 13vPnC Dose 3 (n=133,129,262)
12.25
(10.31 to 14.55)
8.29
(6.78 to 10.13)
10.10
(8.84 to 11.55)
Serotype 6B: After 23vPS Dose (n=133,129,262)
11.10
(9.39 to 13.13)
8.25
(6.80 to 10.01)
9.59
(8.44 to 10.90)
Serotype 7F: After 13vPnC Dose 3 (n=133,130,263)
5.05
(4.39 to 5.81)
5.88
(4.93 to 7.02)
5.44
(4.87 to 6.09)
Serotype 7F: After 23vPS Dose (n=133,130,263)
5.15
(4.50 to 5.90)
5.93
(5.02 to 7.00)
5.52
(4.96 to 6.14)
Serotype 9V: After 13vPnC Dose 3 (n=133,130,263)
5.02
(4.40 to 5.72)
5.49
(4.59 to 6.57)
5.25
(4.70 to 5.86)
Serotype 9V: After 23vPS Dose (n=133,130,263)
5.27
(4.62 to 6.00)
5.83
(4.88 to 6.96)
5.54
(4.96 to 6.18)
Serotype 14: After 13vPnC Dose 3 (n=133,130,263)
13.18
(10.19 to 17.05)
15.35
(11.97 to 19.69)
14.21
(11.89 to 16.98)
Serotype 14: After 23vPS Dose (n=133,130,263)
12.98
(10.10 to 16.67)
16.24
(12.82 to 20.57)
14.50
(12.21 to 17.21)
Serotype 18C: After 13vPnC Dose 3 (n=132,130,262)
3.84
(3.21 to 4.59)
5.17
(4.25 to 6.28)
4.45
(3.90 to 5.08)
Serotype 18C: After 23vPS Dose (n=132,130,262)
3.54
(2.98 to 4.20)
4.80
(3.98 to 5.79)
4.12
(3.62 to 4.68)
Serotype 19A: After 13vPnC Dose 3 (n=133,130,263)
14.16
(12.21 to 16.41)
13.21
(11.13 to 15.68)
13.68
(12.22 to 15.31)
Serotype 19A: After 23vPS Dose (n=133,130,263)
13.16
(11.31 to 15.33)
13.28
(11.24 to 15.69)
13.22
(11.82 to 14.79)
Serotype 19F: After 13vPnC Dose 3 (n=130,127,257)
6.15
(5.09 to 7.45)
5.67
(4.47 to 7.19)
5.91
(5.08 to 6.87)
Serotype 19F: After 23vPS Dose (n=130,127,257)
6.78
(5.65 to 8.14)
5.84
(4.62 to 7.39)
6.30
(5.44 to 7.30)
Serotype 23F: After 13vPnC Dose 3 (n=132,129,261)
6.69
(5.60 to 7.98)
7.30
(5.87 to 9.09)
6.98
(6.07 to 8.03)
Serotype 23F: After 23vPS Dose (n=132,129,261)
5.99
(5.05 to 7.11)
7.03
(5.69 to 8.70)
6.49
(5.66 to 7.43)
11.Other Pre-specified Outcome
Title Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Time Frame 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 133 130 263
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 128, 127, 255)
1.08
(1.01 to 1.16)
1.02
(0.96 to 1.08)
1.05
(1.00 to 1.10)
Serotype 3 (n = 124, 118, 242)
1.11
(1.03 to 1.20)
0.94
(0.88 to 1.00)
1.02
(0.97 to 1.08)
Serotype 4 (n = 133, 128, 261)
1.00
(0.94 to 1.05)
0.94
(0.90 to 0.99)
0.97
(0.94 to 1.01)
Serotype 5 (n = 132, 130, 262)
1.07
(1.02 to 1.13)
1.12
(1.05 to 1.19)
1.09
(1.05 to 1.14)
Serotype 6A (n = 122, 129, 251)
0.97
(0.92 to 1.04)
0.95
(0.91 to 0.99)
0.96
(0.93 to 1.00)
Serotype 6B (n = 133, 129, 262)
0.91
(0.87 to 0.95)
1.00
(0.96 to 1.04)
0.95
(0.92 to 0.98)
Serotype 7F (n = 133, 130, 263)
1.02
(0.97 to 1.07)
1.01
(0.95 to 1.06)
1.01
(0.98 to 1.05)
Serotype 9V (n = 133, 130, 263)
1.05
(1.00 to 1.10)
1.06
(1.01 to 1.11)
1.06
(1.02 to 1.09)
Serotype 14 (n = 133, 130, 263)
0.98
(0.91 to 1.06)
1.06
(0.99 to 1.13)
1.02
(0.97 to 1.07)
Serotype 18C (n = 132, 130, 262)
0.92
(0.88 to 0.96)
0.93
(0.89 to 0.97)
0.92
(0.90 to 0.95)
Serotype 19A (n = 133, 130, 263)
0.93
(0.89 to 0.97)
1.01
(0.96 to 1.05)
0.97
(0.94 to 1.00)
Serotype 19F (n = 130, 127, 257)
1.10
(1.04 to 1.17)
1.03
(0.97 to 1.09)
1.07
(1.02 to 1.11)
Serotype 23F (n = 132, 129, 261)
0.90
(0.86 to 0.94)
0.96
(0.91 to 1.02)
0.93
(0.89 to 0.96)
12.Other Pre-specified Outcome
Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Hide Description Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 132 128 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Serotype 1: After 13vPnC Dose 3 (n=131,125,256)
70
(53.4 to 93.0)
67
(50.2 to 90.6)
69
(56.4 to 84.3)
Serotype 1: After 23vPS Dose (n=131,125,256)
100
(76.6 to 130.3)
66
(49.0 to 90.2)
82
(66.9 to 100.2)
Serotype 3: After 13vPnC Dose 3 (n=132,128,260)
114
(94.6 to 136.7)
78
(61.3 to 98.7)
94
(81.1 to 109.7)
Serotype 3: After 23vPS Dose (n=132,128,260)
148
(123.9 to 177.3)
103
(81.6 to 130.9)
124
(107.0 to 144.0)
Serotype 4: After 13vPnC Dose 3 (n=127,126,253)
3213
(2698.5 to 3826.6)
1888
(1427.3 to 2498.1)
2466
(2087.0 to 2913.5)
Serotype 4: After 23vPS Dose (n=127,126,253)
3553
(2984.9 to 4229.7)
1831
(1366.0 to 2453.7)
2554
(2146.3 to 3038.7)
Serotype 5: After 13vPnC Dose 3 (n=129,124,253)
270
(197.0 to 370.1)
143
(97.5 to 209.6)
198
(154.2 to 253.5)
Serotype 5: After 23vPS Dose (n=129,124,253)
378
(276.5 to 516.9)
186
(130.9 to 264.4)
267
(210.6 to 338.6)
Serotype 6A: After 13vPnC Dose 3 (n=132,127,259)
8011
(6580.0 to 9752.1)
2956
(2240.1 to 3900.3)
4913
(4109.7 to 5873.6)
Serotype 6A: After 23vPS Dose (n=132,127,259)
7236
(5936.2 to 8819.4)
2707
(2060.8 to 3556.3)
4468
(3743.3 to 5333.1)
Serotype 6B: After 13vPnC Dose 3 (n=130,126,256)
7102
(5853.9 to 8615.8)
3666
(2720.7 to 4940.5)
5129
(4283.9 to 6141.0)
Serotype 6B: After 23vPS Dose (n=130,126,256)
6652
(5460.8 to 8102.8)
3324
(2496.6 to 4426.2)
4728
(3961.1 to 5643.2)
Serotype 7F: After 13vPnC Dose 3 (n=131,125,256)
4640
(3915.9 to 5497.9)
2821
(2283.2 to 3484.4)
3639
(3171.6 to 4174.8)
Serotype 7F: After 23vPS Dose (n=131,125,256)
5260
(4470.4 to 6189.9)
3027
(2455.7 to 3731.3)
4016
(3508.3 to 4597.9)
Serotype 9V: After 13vPnC Dose 3 (n=127,125,252)
4501
(3606.4 to 5618.0)
1980
(1394.6 to 2811.7)
2995
(2424.2 to 3700.8)
Serotype 9V: After 23vPS Dose (n=127,125,252)
5114
(4090.6 to 6393.0)
2037
(1452.6 to 2857.6)
3240
(2629.5 to 3991.2)
Serotype 14: After 13vPnC Dose 3 (n=127,126,253)
4023
(3317.5 to 4879.5)
1431
(1115.7 to 1836.1)
2405
(2030.8 to 2847.1)
Serotype 14: After 23vPS Dose (n=127,126,253)
4718
(3861.6 to 5764.9)
1620
(1284.5 to 2043.0)
2771
(2346.9 to 3270.7)
Serotype 18C: After 13vPnC Dose 3 (n=129,121,250)
5455
(4401.5 to 6761.4)
1667
(1172.5 to 2370.8)
3074
(2479.2 to 3810.5)
Serotype 18C: After 23vPS Dose (n=129,121,250)
6468
(5341.1 to 7832.2)
1835
(1328.1 to 2535.5)
3515
(2878.5 to 4292.8)
Serotype 19A: After 13vPnC Dose 3 (n=131,125,256)
1021
(837.5 to 1245.6)
603
(456.7 to 796.3)
790
(665.2 to 937.4)
Serotype 19A: After 23vPS Dose (n=131,125,256)
1244
(1012.1 to 1529.5)
691
(531.0 to 898.6)
933
(788.2 to 1105.5)
Serotype 19F: After 13vPnC Dose 3 (n=126,117,243)
1166
(884.3 to 1537.7)
564
(375.0 to 848.1)
822
(642.8 to 1051.0)
Serotype 19F: After 23vPS Dose (n=126,117,243)
1696
(1296.5 to 2217.5)
790
(547.5 to 1139.7)
1174
(934.2 to 1474.8)
Serotype 23F: After 13vPnC Dose 3 (n=128,126,254)
2346
(1883.3 to 2922.6)
650
(435.3 to 969.9)
1241
(976.6 to 1576.7)
Serotype 23F: After 23vPS Dose (n=128,126,254)
2595
(2143.3 to 3141.5)
580
(386.1 to 871.8)
1234
(970.1 to 1570.3)
13.Other Pre-specified Outcome
Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Hide Description GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Time Frame 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 132 128 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
Serotype 1 (n = 131, 125, 256)
1.4
(1.23 to 1.63)
1.0
(0.86 to 1.13)
1.2
(1.08 to 1.31)
Serotype 3 (n = 132, 128, 260)
1.3
(1.15 to 1.48)
1.3
(1.17 to 1.51)
1.3
(1.20 to 1.44)
Serotype 4 (n = 127, 126, 253)
1.1
(1.04 to 1.18)
1.0
(0.87 to 1.09)
1.0
(0.97 to 1.10)
Serotype 5 (n = 129, 124, 253)
1.4
(1.15 to 1.71)
1.3
(1.13 to 1.50)
1.4
(1.20 to 1.53)
Serotype 6A (n = 132, 127, 259)
0.9
(0.85 to 0.96)
0.9
(0.86 to 0.97)
0.9
(0.87 to 0.95)
Serotype 6B (n = 130, 126, 256)
0.9
(0.87 to 1.01)
0.9
(0.79 to 1.04)
0.9
(0.86 to 0.99)
Serotype 7F (n = 131, 125, 256)
1.1
(1.06 to 1.21)
1.1
(0.93 to 1.23)
1.1
(1.02 to 1.19)
Serotype 9V (n = 127, 125, 252)
1.1
(1.05 to 1.23)
1.0
(0.84 to 1.27)
1.1
(0.97 to 1.21)
Serotype 14 (n = 127, 126, 253)
1.2
(1.07 to 1.28)
1.1
(1.03 to 1.24)
1.2
(1.08 to 1.23)
Serotype 18C (n = 129, 121, 250)
1.2
(1.04 to 1.35)
1.1
(0.92 to 1.31)
1.1
(1.03 to 1.27)
Serotype 19A (n = 131, 125, 256)
1.2
(1.11 to 1.34)
1.1
(1.03 to 1.27)
1.2
(1.10 to 1.27)
Serotype 19F (n = 126, 117, 243)
1.5
(1.25 to 1.69)
1.4
(1.14 to 1.72)
1.4
(1.26 to 1.62)
Serotype 23F (n = 128, 126, 254)
1.1
(0.96 to 1.28)
0.9
(0.81 to 0.98)
1.0
(0.91 to 1.09)
14.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Hide Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.
Time Frame Within 14 days after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 120 123 243
Measure Type: Number
Unit of Measure: percentage of participants
Redness: Any (n = 92, 88, 180) 20.7 2.3 11.7
Redness: Mild (n = 91, 88, 179) 19.8 2.3 11.2
Redness: Moderate (n = 85, 88, 173) 2.4 0.0 1.2
Redness: Severe (n = 84, 88, 172) 0.0 0.0 0.0
Swelling: Any (n = 97, 94, 191) 29.9 9.6 19.9
Swelling: Mild (n = 91, 93, 184) 17.6 8.6 13.0
Swelling: Moderate (n = 92, 89, 181) 16.3 1.1 8.8
Swelling: Severe (n = 84, 88, 172) 1.2 0.0 0.6
Pain at Injection Site: Any (n = 117, 121, 238) 68.4 62.8 65.5
Pain at Injection Site: Mild (n = 112, 116, 228) 55.4 56.0 55.7
Pain at Injection Site: Moderate (n = 94, 94, 188) 28.7 18.1 23.4
Pain at Injection Site: Severe (n = 86, 89, 175) 8.1 2.2 5.1
15.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Hide Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Time Frame Within 14 days after 13vPnC Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 120 119 239
Measure Type: Number
Unit of Measure: percentage of participants
Redness: Any (n = 101, 86, 187) 13.9 2.3 8.6
Redness: Mild (n = 100, 86, 186) 10.0 2.3 6.5
Redness: Moderate (n = 95, 85, 180) 4.2 0.0 2.2
Redness: Severe (n = 93, 85, 178) 1.1 0.0 0.6
Swelling: Any (n = 103, 88, 191) 25.2 8.0 17.3
Swelling: Mild (n = 102, 88, 190) 18.6 8.0 13.7
Swelling: Moderate (n = 99, 85, 184) 12.1 0.0 6.5
Swelling: Severe (n = 93, 85, 178) 0.0 0.0 0.0
Pain at Injection Site: Any (n = 117, 119, 236) 60.7 79.8 70.3
Pain at Injection Site: Mild (n = 110, 117, 227) 49.1 72.6 61.2
Pain at Injection Site: Moderate (n= 103, 96, 199) 24.3 27.1 25.6
Pain at Injection Site: Severe (n = 93, 86, 179) 5.4 3.5 4.5
16.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Hide Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Time Frame Within 14 days after 13vPnC Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 104 109 213
Measure Type: Number
Unit of Measure: percentage of participants
Redness: Any (n = 84, 70, 154) 8.3 0.0 4.5
Redness: Mild (n = 83, 70, 153) 7.2 0.0 3.9
Redness: Moderate (n = 82, 70, 152) 2.4 0.0 1.3
Redness: Severe (n = 80, 70, 150) 0.0 0.0 0.0
Swelling: Any (n = 89, 71, 160) 18.0 4.2 11.9
Swelling: Mild (n = 86, 71, 157) 10.5 4.2 7.6
Swelling: Moderate (n = 84, 70, 154) 9.5 0.0 5.2
Swelling: Severe (n = 80, 70, 150) 0.0 0.0 0.0
Pain at Injection Site: Any (n = 104, 109, 213) 52.9 69.7 61.5
Pain at Injection Site: Mild (n = 96, 105, 201) 41.7 63.8 53.2
Pain at Injection Site: Moderate (n = 89, 78, 167) 19.1 24.4 21.6
Pain at Injection Site: Severe (n = 83, 73, 156) 4.8 5.5 5.1
17.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Hide Description Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
Time Frame Within 14 days after 13vPnC Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 128 138 266
Measure Type: Number
Unit of Measure: percentage of participants
Fever: >=38 degrees C (n= 94, 95, 189) 19.1 17.9 18.5
Fever: >=38, <38.5 degrees C (n = 87, 92, 179) 8.0 8.7 8.4
Fever: >=38.5, <39 degrees C (n = 85, 89, 174) 2.4 3.4 2.9
Fever: >=39, =<40 degrees C (n = 86, 88, 174) 4.7 2.3 3.4
Fever: >40 degrees C (n = 88, 93, 181) 6.8 8.6 7.7
Fatigue: Any (n = 111, 119, 230) 47.7 58.8 53.5
Fatigue: Mild (n = 105, 113, 218) 33.3 51.3 42.7
Fatigue: Moderate (n = 96, 99, 195) 26.0 28.3 27.2
Fatigue: Severe (n = 86, 92, 178) 9.3 8.7 9.0
Headache: Any (n = 107, 113, 220) 39.3 61.1 50.5
Headache: Mild (n = 100, 109, 209) 33.0 57.8 45.9
Headache: Moderate (n = 94, 97, 191) 18.1 22.7 20.4
Headache: Severe (n = 87, 89, 176) 6.9 9.0 8.0
Vomiting: Any (n = 89, 91, 180) 18.0 7.7 12.8
Vomiting: Mild (n = 89, 91, 180) 14.6 7.7 11.1
Vomiting: Moderate (n = 84, 88, 172) 2.4 0.0 1.2
Vomiting: Severe (n = 85, 88, 173) 2.4 0.0 1.2
Diarrhea: Any (n = 94, 105, 199) 25.5 34.3 30.2
Diarrhea: Mild (n = 92, 104, 196) 19.6 29.8 25.0
Diarrhea: Moderate (n = 86, 91, 177) 8.1 7.7 7.9
Diarrhea: Severe (n = 85, 88, 173) 1.2 1.1 1.2
Muscle Pain: Any (n = 108, 118, 226) 48.1 62.7 55.8
Muscle Pain: Mild (n = 103, 110, 213) 36.9 56.4 46.9
Muscle Pain: Moderate (n = 89, 98, 187) 19.1 19.4 19.3
Muscle Pain: Severe (n = 86, 91, 177) 5.8 5.5 5.6
Joint Pain: Any (n = 100, 105, 205) 34.0 42.9 38.5
Joint Pain: Mild (n = 98, 101, 199) 26.5 36.6 31.7
Joint Pain: Moderate (n = 89, 95, 184) 12.4 17.9 15.2
Joint Pain: Severe (n = 84, 91, 175) 4.8 4.4 4.6
Use of Medication to Treat Pain (n = 101, 96, 197) 33.7 24.0 28.9
Use of Medication to Treat Fever (n=112, 107, 219) 44.6 39.3 42.0
18.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Hide Description Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
Time Frame Within 14 days after 13vPnC Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 123 120 243
Measure Type: Number
Unit of Measure: percentage of participants
Fever: >=38 degrees C (n= 102, 88, 190) 16.7 11.4 14.2
Fever: >=38, <38.5 degrees C (n = 96, 87, 183) 7.3 9.2 8.2
Fever: >=38.5, <39 degrees C (n = 98, 85, 183) 6.1 1.2 3.8
Fever: >=39, =<40 degrees C (n = 97, 87, 184) 7.2 3.4 5.4
Fever: >40 degrees C (n = 95, 85, 180) 1.1 1.2 1.1
Fatigue: Any (n = 106, 105, 211) 33.0 48.6 40.8
Fatigue: Mild (n = 104, 103, 207) 24.0 42.7 33.3
Fatigue: Moderate (n = 96, 88, 184) 10.4 21.6 15.8
Fatigue: Severe (n = 95, 88, 183) 7.4 5.7 6.6
Headache: Any (n = 101, 106, 207) 28.7 49.1 39.1
Headache: Mild (n = 97, 102, 199) 18.6 40.2 29.6
Headache: Moderate (n = 97, 93, 190) 13.4 28.0 20.5
Headache: Severe (n = 94, 88, 182) 2.1 3.4 2.7
Vomiting: Any (n = 96, 89, 185) 10.4 10.1 10.3
Vomiting: Mild (n = 94, 89, 183) 6.4 9.0 7.7
Vomiting: Moderate (n = 94, 85, 179) 3.2 1.2 2.2
Vomiting: Severe (n = 94, 85, 179) 3.2 0.0 1.7
Diarrhea: Any (n = 95, 95, 190) 10.5 26.3 18.4
Diarrhea: Mild (n = 94, 93, 187) 7.4 24.7 16.0
Diarrhea: Moderate (n = 93, 87, 180) 3.2 8.0 5.6
Diarrhea: Severe (n = 94, 85, 179) 4.3 1.2 2.8
Muscle Pain: Any (n = 112, 104, 216) 37.5 52.9 44.9
Muscle Pain: Mild (n = 105, 103, 208) 25.7 46.6 36.1
Muscle Pain: Moderate (n = 100, 91, 191) 15.0 20.9 17.8
Muscle Pain: Severe (n = 95, 85, 180) 5.3 2.4 3.9
Joint Pain: Any (n = 106, 95, 201) 26.4 34.7 30.3
Joint Pain: Mild (n = 100, 93, 193) 16.0 29.0 22.3
Joint Pain: Moderate (n = 99, 89, 188) 11.1 12.4 11.7
Joint Pain: Severe (n = 94, 85, 179) 4.3 2.4 3.4
Use of Medication to Treat Pain (n = 100, 91, 191) 20.0 17.6 18.8
Use of Medication to Treat Fever (n=102, 96, 198) 28.4 26.0 27.3
19.Other Pre-specified Outcome
Title Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Hide Description Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
Time Frame Within 14 days after 13vPnC Dose 3
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Hide Analysis Population Description
Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Arm/Group Title 13vPnC, 23vPS (Pediatric Participants) 13vPnC, 23vPS (Adult Participants) 13vPnC, 23vPS (All Participants)
Hide Arm/Group Description:
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Overall Number of Participants Analyzed 106 113 219
Measure Type: Number
Unit of Measure: percentage of participants
Fever: >=38 degrees C (n= 85, 73, 158) 10.6 11.0 10.8
Fever: >=38, <38.5 degrees C (n = 82, 73, 155) 6.1 5.5 5.8
Fever: >=38.5, <39 degrees C (n = 81, 72, 153) 2.5 5.6 3.9
Fever: >=39, =<40 degrees C (n = 82, 70, 152) 2.4 2.9 2.6
Fever: >40 degrees C (n = 83, 70, 153) 3.6 1.4 2.6
Fatigue: Any (n = 92, 91, 183) 25.0 47.3 36.1
Fatigue: Mild (n = 89, 88, 177) 20.2 39.8 29.9
Fatigue: Moderate (n = 83, 80, 163) 6.0 25.0 15.3
Fatigue: Severe (n = 83, 73, 156) 4.8 8.2 6.4
Headache: Any (n = 88, 89, 177) 18.2 46.1 32.2
Headache: Mild (n = 84, 87, 171) 10.7 41.4 26.3
Headache: Moderate (n = 83, 77, 160) 8.4 19.5 13.8
Headache: Severe (n = 82, 72, 154) 3.7 6.9 5.2
Vomiting: Any (n = 85, 74, 159) 8.2 9.5 8.8
Vomiting: Mild (n = 84, 72, 156) 7.1 5.6 6.4
Vomiting: Moderate (n = 82, 73, 155) 2.4 5.5 3.9
Vomiting: Severe (n = 81, 72, 153) 1.2 2.8 2.0
Diarrhea: Any (n = 81, 81, 162) 4.9 28.4 16.7
Diarrhea: Mild (n = 81, 79, 160) 4.9 25.3 15.0
Diarrhea: Moderate (n = 80, 73, 153) 1.3 6.8 3.9
Diarrhea: Severe (n = 81, 73, 154) 1.2 4.1 2.6
Muscle Pain: Any (n = 99, 92, 191) 37.4 47.8 42.4
Muscle Pain: Mild (n = 93, 89, 182) 25.8 37.1 31.3
Muscle Pain: Moderate (n = 85, 78, 163) 12.9 24.4 18.4
Muscle Pain: Severe (n = 84, 72, 156) 8.3 5.6 7.1
Joint Pain: Any (n = 91, 83, 174) 24.2 32.5 28.2
Joint Pain: Mild (n = 88, 82, 170) 15.9 28.0 21.8
Joint Pain: Moderate (n = 82, 77, 159) 7.3 15.6 11.3
Joint Pain: Severe (n = 81, 71, 152) 2.5 2.8 2.6
Use of Medication to Treat Pain (n = 90, 79, 169) 17.8 21.5 19.5
Use of Medication to Treat Fever (n = 89, 75, 164) 20.2 20.0 20.1
Time Frame Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Adverse Event Reporting Description Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
 
Arm/Group Title Prior 13vPnC Dose 1 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 23vPS Dose Follow-up
Hide Arm/Group Description Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1. Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2. Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3. Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose. Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose. Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
All-Cause Mortality
Prior 13vPnC Dose 1 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 23vPS Dose Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Prior 13vPnC Dose 1 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 23vPS Dose Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/301 (0.33%)   1/301 (0.33%)   4/290 (1.38%)   1/286 (0.35%)   0/282 (0.00%)   1/282 (0.35%) 
Blood and lymphatic system disorders             
Lymphadenopathy * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Gastrointestinal disorders             
Haemorrhoids * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Infections and infestations             
Lobar pneumonia * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Pharyngitis bacterial * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/286 (0.00%)  0/282 (0.00%)  1/282 (0.35%) 
Tonsillitis * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Croup infectious * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Injury, poisoning and procedural complications             
Road traffic accident * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/286 (0.35%)  0/282 (0.00%)  0/282 (0.00%) 
Nervous system disorders             
Convulsion * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prior 13vPnC Dose 1 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 23vPS Dose Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/301 (5.32%)   216/301 (71.76%)   171/290 (58.97%)   137/286 (47.90%)   31/282 (10.99%)   2/282 (0.71%) 
Blood and lymphatic system disorders             
Lymphadenopathy * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  1/182 (0.55%) 
Eye disorders             
Conjunctivitis * 1  1/301 (0.33%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Gastrointestinal disorders             
Nausea * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Salivary gland enlargement * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Vomiting * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Abdominal pain * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Gastritis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Stomatitis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Abdominal pain upper * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Diarrhoea * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Gastroduodenitis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  1/182 (0.55%) 
General disorders             
Fatigue * 1  0/301 (0.00%)  3/301 (1.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Pyrexia * 1  0/301 (0.00%)  2/301 (0.66%)  2/290 (0.69%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Influenza like illness * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Injection site pain * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  6/282 (2.13%)  0/182 (0.00%) 
Injection site reaction * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  2/282 (0.71%)  0/182 (0.00%) 
Injection site swelling * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  2/282 (0.71%)  0/182 (0.00%) 
Vaccination site swelling * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  2/282 (0.71%)  0/182 (0.00%) 
Fever (≥38°C)  3  0/0  35/189 (18.52%)  27/190 (14.21%)  17/158 (10.76%)  0/0  0/0 
Fever (≥38°C but <38.5°C)  3  0/0  15/179 (8.38%)  15/183 (8.20%)  9/155 (5.81%)  0/0  0/0 
Fever (≥38.5°C but <39°C)  3  0/0  5/174 (2.87%)  7/183 (3.83%)  6/153 (3.92%)  0/0  0/0 
Fever (≥39°C but ≤40°C)  3  0/0  6/174 (3.45%)  10/184 (5.43%)  4/152 (2.63%)  0/0  0/0 
Fever (>40°C)  3 [1]  0/0  14/181 (7.73%)  2/180 (1.11%)  4/153 (2.61%)  0/0  0/0 
Fatigue (Any)  3  0/0  123/230 (53.48%)  86/211 (40.76%)  66/183 (36.07%)  0/0  0/0 
Fatigue (Mild)  3  0/0  93/218 (42.66%)  69/207 (33.33%)  53/177 (29.94%)  0/0  0/0 
Fatigue (Moderate)  3  0/0  53/195 (27.18%)  29/184 (15.76%)  25/163 (15.34%)  0/0  0/0 
Fatigue (Severe)  3  0/0  16/178 (8.99%)  12/183 (6.56%)  10/156 (6.41%)  0/0  0/0 
Headache (Any)  3  0/0  111/220 (50.45%)  81/207 (39.13%)  57/177 (32.20%)  0/0  0/0 
Headache (Mild)  3  0/0  96/209 (45.93%)  59/199 (29.65%)  45/171 (26.32%)  0/0  0/0 
Headache (Moderate)  3  0/0  39/191 (20.42%)  39/190 (20.53%)  22/160 (13.75%)  0/0  0/0 
Headache (Severe)  3  0/0  14/176 (7.95%)  5/182 (2.75%)  8/154 (5.19%)  0/0  0/0 
Vomiting (Any)  3  0/0  23/180 (12.78%)  19/185 (10.27%)  14/159 (8.81%)  0/0  0/0 
Vomiting (Mild)  3  0/0  20/180 (11.11%)  14/183 (7.65%)  10/156 (6.41%)  0/0  0/0 
Vomiting (Moderate)  3  0/0  2/172 (1.16%)  4/179 (2.23%)  6/155 (3.87%)  0/0  0/0 
Vomiting (Severe)  3 [2]  0/0  2/173 (1.16%)  3/179 (1.68%)  3/153 (1.96%)  0/0  0/0 
Diarrhea (Any)  3  0/0  60/199 (30.15%)  35/190 (18.42%)  27/162 (16.67%)  0/0  0/0 
Diarrhea (Mild)  3  0/0  49/196 (25.00%)  30/187 (16.04%)  24/160 (15.00%)  0/0  0/0 
Diarrhea (Moderate)  3  0/0  14/177 (7.91%)  10/180 (5.56%)  6/153 (3.92%)  0/0  0/0 
Diarrhea (Severe)  3  0/0  2/173 (1.16%)  5/179 (2.79%)  4/154 (2.60%)  0/0  0/0 
Muscle pain (Any)  3  0/0  126/226 (55.75%)  97/216 (44.91%)  81/191 (42.41%)  0/0  0/0 
Muscle pain (Mild)  3  0/0  100/213 (46.95%)  75/208 (36.06%)  57/182 (31.32%)  0/0  0/0 
Muscle pain (Moderate)  3  0/0  36/187 (19.25%)  34/191 (17.80%)  30/163 (18.40%)  0/0  0/0 
Muscle pain (Severe)  3  0/0  10/177 (5.65%)  7/180 (3.89%)  11/156 (7.05%)  0/0  0/0 
Joint pain (Any)  3  0/0  79/205 (38.54%)  61/201 (30.35%)  49/174 (28.16%)  0/0  0/0 
Joint pain (Mild)  3  0/0  63/199 (31.66%)  43/193 (22.28%)  37/170 (21.76%)  0/0  0/0 
Joint pain (Moderate)  3  0/0  28/184 (15.22%)  22/188 (11.70%)  18/159 (11.32%)  0/0  0/0 
Joint pain (Severe)  3  0/0  8/175 (4.57%)  6/179 (3.35%)  4/152 (2.63%)  0/0  0/0 
Infections and infestations             
Influenza * 1  0/301 (0.00%)  5/301 (1.66%)  1/290 (0.34%)  8/186 (4.30%)  3/282 (1.06%)  1/182 (0.55%) 
Gastroenteritis * 1  0/301 (0.00%)  3/301 (1.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Upper respiratory tract infection * 1  6/301 (1.99%)  3/301 (1.00%)  4/290 (1.38%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Sinusitis * 1  0/301 (0.00%)  2/301 (0.66%)  1/290 (0.34%)  1/186 (0.54%)  1/282 (0.35%)  1/182 (0.55%) 
Cystitis * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Herpes virus infection * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Oral herpes * 1  0/301 (0.00%)  1/301 (0.33%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Otitis media * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Respiratory tract infection * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Rhinitis * 1  1/301 (0.33%)  1/301 (0.33%)  2/290 (0.69%)  4/186 (2.15%)  2/282 (0.71%)  0/182 (0.00%) 
Subcutaneous abscess * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Tinea capitis * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Tonsillitis * 1  1/301 (0.33%)  1/301 (0.33%)  0/290 (0.00%)  2/186 (1.08%)  0/282 (0.00%)  0/182 (0.00%) 
Tooth infection * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Viraemia * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Body tinea * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Lower respiratory tract infection * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Pharyngitis * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  1/186 (0.54%)  1/282 (0.35%)  1/182 (0.55%) 
Pharyngitis bacterial * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Tooth abscess * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Varicella * 1  3/301 (1.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Impetigo * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Laryngitis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Pneumonia * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Oral candidiasis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  1/182 (0.55%) 
Parotitis * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Injury, poisoning and procedural complications             
Radius fracture * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Lip injury * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Procedural pain * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  2/186 (1.08%)  1/282 (0.35%)  0/182 (0.00%) 
Pain in extremity * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Myalgia * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  1/282 (0.35%)  0/182 (0.00%) 
Back pain * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Spondylolisthesis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Scoliosis * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  1/182 (0.55%) 
Nervous system disorders             
Headache * 1  0/301 (0.00%)  3/301 (1.00%)  1/290 (0.34%)  1/186 (0.54%)  2/282 (0.71%)  0/182 (0.00%) 
Intercostal neuralgia * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Sciatica * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Dizziness * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Psychiatric disorders             
Abnormal dreams * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Agitation * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Depression * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Reproductive system and breast disorders             
Dysmenorrhoea * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Gynaecomastia * 1  1/301 (0.33%)  0/301 (0.00%)  0/290 (0.00%)  0/286 (0.00%)  0/282 (0.00%)  0/282 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough * 1  4/301 (1.33%)  4/301 (1.33%)  3/290 (1.03%)  1/186 (0.54%)  4/282 (1.42%)  0/182 (0.00%) 
Oropharyngeal pain * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  2/186 (1.08%)  0/282 (0.00%)  0/182 (0.00%) 
Rhinorrhoea * 1  0/301 (0.00%)  1/301 (0.33%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Upper-airway cough syndrome * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Wheezing * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Nasal disorder * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  1/186 (0.54%)  0/282 (0.00%)  0/182 (0.00%) 
Skin and subcutaneous tissue disorders             
Eczema * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Exfoliative rash * 1  0/301 (0.00%)  1/301 (0.33%)  0/290 (0.00%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Rash * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  2/186 (1.08%)  0/282 (0.00%)  0/182 (0.00%) 
Pruritus * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Urticaria * 1  0/301 (0.00%)  0/301 (0.00%)  0/290 (0.00%)  0/186 (0.00%)  1/282 (0.35%)  0/182 (0.00%) 
Redness (Any)  2  0/0  21/180 (11.67%)  16/187 (8.56%)  7/154 (4.55%)  0/0  0/0 
Redness (Mild)  2  0/0  20/179 (11.17%)  12/186 (6.45%)  6/153 (3.92%)  0/0  0/0 
Redness (Moderate)  2  0/0  2/173 (1.16%)  4/180 (2.22%)  2/152 (1.32%)  0/0  0/0 
Redness (Severe)  2  0/0  0/172 (0.00%)  1/178 (0.56%)  0/150 (0.00%)  0/0  0/0 
Swelling (Any)  2  0/0  38/191 (19.90%)  33/191 (17.28%)  19/160 (11.88%)  0/0  0/0 
Swelling (Mild)  2  0/0  24/184 (13.04%)  26/190 (13.68%)  12/157 (7.64%)  0/0  0/0 
Swelling (Moderate)  2  0/0  16/181 (8.84%)  12/184 (6.52%)  8/154 (5.19%)  0/0  0/0 
Swelling (Severe)  2  0/0  1/172 (0.58%)  0/178 (0.00%)  0/150 (0.00%)  0/0  0/0 
Pain at injection site (Any)  2  0/0  156/238 (65.55%)  166/236 (70.34%)  131/213 (61.50%)  0/0  0/0 
Pain at injection site (Mild)  2  0/0  127/228 (55.70%)  139/227 (61.23%)  107/201 (53.23%)  0/0  0/0 
Pain at injection site (Moderate)  2  0/0  44/188 (23.40%)  51/199 (25.63%)  36/167 (21.56%)  0/0  0/0 
Pain at injection site (Severe)  2  0/0  9/175 (5.14%)  8/179 (4.47%)  8/156 (5.13%)  0/0  0/0 
Vascular disorders             
Hypertension * 1  0/301 (0.00%)  0/301 (0.00%)  1/290 (0.34%)  0/186 (0.00%)  0/282 (0.00%)  0/182 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
2
Term from vocabulary, Local reactions
3
Term from vocabulary, Systemic events
[1]
All reporting of fever >40 degrees C except 2 participants in 13vPnC Dose 1 and 1 participant in 13vPnC Dose 3 were confirmed as data entry errors.
[2]
All reporting of severe vomiting were confirmed as data entry errors.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00962780    
Obsolete Identifiers: NCT01098370
Other Study ID Numbers: 6115A1-3002
B1851021
First Submitted: August 18, 2009
First Posted: August 20, 2009
Results First Submitted: March 17, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014