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Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated (AB PERSISTENCE)

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ClinicalTrials.gov Identifier: NCT01025336
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Healthy
Intervention Other: Blood draw
Enrollment 962
Recruitment Details  
Pre-assignment Details Only participants who completed Parent Study 6115A1-3010 (NCT00574548) or Parent Study 6115A1-3005 (NCT00546572) were enrolled in this follow-up study 6115A1-3018 (NCT01025336).
Arm/Group Title 13vPnC/13vPnC Group (23vPS Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve) 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Hide Arm/Group Description Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Period Title: Overall Study
Started 130 210 179 221 222
Completed 130 210 179 219 222
Not Completed 0 0 0 2 0
Reason Not Completed
Protocol Violation             0             0             0             2             0
Arm/Group Title 13vPnC/13vPnC Group (23vPS Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve) 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) Total
Hide Arm/Group Description Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) Total of all reporting groups
Overall Number of Baseline Participants 130 210 179 221 222 962
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 210 participants 179 participants 221 participants 222 participants 962 participants
64.0  (1.4) 64.1  (1.4) 64.2  (1.4) 78.3  (4.5) 77.8  (4.1) 70.5  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 210 participants 179 participants 221 participants 222 participants 962 participants
Female
76
  58.5%
125
  59.5%
102
  57.0%
114
  51.6%
115
  51.8%
532
  55.3%
Male
54
  41.5%
85
  40.5%
77
  43.0%
107
  48.4%
107
  48.2%
430
  44.7%
1.Primary Outcome
Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Time Frame Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.
Arm/Group Title 13vPnC/13vPnC Group (23vPs Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve)
Hide Arm/Group Description:
Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 129 209 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1
54
(40.8 to 71.0)
52
(40.9 to 65.5)
36
(27.1 to 46.7)
Serotype 3
19
(15.0 to 23.5)
27
(22.2 to 32.3)
18
(14.4 to 21.9)
Serotype 4
328
(229.0 to 469.0)
355
(264.7 to 475.9)
183
(127.7 to 263.2)
Serotype 5
29
(20.4 to 41.4)
76
(58.0 to 99.7)
44
(32.9 to 59.6)
Serotype 6A
316
(216.5 to 461.2)
225
(163.6 to 308.3)
102
(71.4 to 146.9)
Serotype 6B
785
(540.6 to 1140.2)
593
(441.4 to 797.3)
324
(225.0 to 466.1)
Serotype 7F
247
(160.4 to 380.9)
412
(313.1 to 541.2)
145
(100.3 to 210.7)
Serotype 9V
211
(134.3 to 330.9)
221
(154.2 to 316.0)
129
(84.5 to 196.5)
Serotype 14
379
(273.6 to 526.2)
416
(316.2 to 548.2)
383
(286.9 to 510.6)
Serotype 18C
393
(271.3 to 569.3)
527
(401.7 to 690.5)
337
(240.7 to 471.7)
Serotype 19A
244
(189.1 to 314.1)
313
(263.1 to 372.3)
170
(134.4 to 214.8)
Serotype 19F
256
(182.4 to 359.0)
426
(343.7 to 527.7)
195
(145.1 to 262.1)
Serotype 23F
110
(73.9 to 165.0)
64
(47.6 to 86.5)
35
(25.6 to 48.6)
2.Primary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Time Frame Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Hide Arm/Group Description:
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 220 222
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1
38
(30.9 to 47.9)
22
(17.5 to 27.8)
Serotype 3
20
(16.5 to 23.4)
16
(13.3 to 19.2)
Serotype 4
265
(200.8 to 348.5)
172
(129.0 to 230.1)
Serotype 5
58
(45.1 to 74.1)
42
(32.2 to 55.6)
Serotype 6A
250
(187.3 to 334.0)
115
(84.5 to 156.8)
Serotype 6B
510
(378.2 to 686.4)
381
(281.9 to 513.9)
Serotype 7F
173
(126.0 to 237.5)
115
(81.6 to 160.9)
Serotype 9V
81
(55.1 to 117.9)
68
(47.4 to 98.5)
Serotype 14
202
(154.6 to 265.0)
240
(181.0 to 317.0)
Serotype 18C
540
(435.5 to 668.5)
360
(273.6 to 474.5)
Serotype 19A
232
(193.2 to 278.1)
181
(146.7 to 222.9)
Serotype 19F
277
(218.6 to 351.7)
158
(119.3 to 209.9)
Serotype 23F
103
(78.0 to 135.5)
45
(33.5 to 59.6)
3.Secondary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve)
Hide Arm/Group Description:
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 126 204 175
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1, 1 Month Post Vax 2
141
(110.4 to 179.7)
149
(123.5 to 180.6)
70
(53.4 to 91.2)
Serotype 1, 1 Year Post Vax 2
54
(40.7 to 70.4)
52
(41.1 to 66.1)
36
(27.6 to 47.9)
Serotype 3, 1 Month Post Vax 2
87
(73.7 to 103.8)
130
(112.8 to 150.3)
50
(40.2 to 63.1)
Serotype 3, 1 Year Post Vax 2
18
(14.6 to 22.9)
27
(22.2 to 32.5)
18
(14.5 to 22.2)
Serotype 4, 1 Month Post Vax 2
1284
(992.3 to 1661.9)
1375
(1137.0 to 1663.8)
898
(684.1 to 1179.5)
Serotype 4, 1 Year Post Vax 2
318
(220.9 to 458.7)
369
(276.1 to 493.9)
203
(142.0 to 291.4)
Serotype 5, 1 Month Post Vax 2
95
(67.1 to 133.2)
223
(180.7 to 276.3)
80
(59.7 to 108.3)
Serotype 5, 1 Year Post Vax 2
29
(20.3 to 42.5)
72
(54.6 to 95.1)
41
(30.3 to 56.2)
Serotype 6A, 1 Month Post Vax 2
2120
(1614.1 to 2783.9)
1307
(1021.4 to 1672.8)
933
(682.1 to 1276.2)
Serotype 6A, 1 Year Post Vax 2
304
(207.7 to 446.3)
266
(195.2 to 362.6)
115
(79.3 to 166.3)
Serotype 6B, 1 Month Post Vax 2
1683
(1253.6 to 2258.3)
1232
(965.9 to 1570.4)
740
(534.8 to 1024.2)
Serotype 6B, 1 Year Post Vax 2
847
(590.8 to 1214.8)
637
(476.3 to 851.6)
352
(244.8 to 505.5)
Serotype 7F, 1 Month Post Vax 2
306
(201.8 to 462.5)
667
(531.5 to 836.8)
131
(87.8 to 496.9)
Serotype 7F, 1 Year Post Vax 2
237
(152.2 to 369.9)
412
(313.2 to 541.5)
148
(101.4 to 215.1)
Serotype 9V, 1 Month Post Vax 2
385
(252.6 to 586.8)
419
(298.6 to 588.0)
122
(80.0 to 186.1)
Serotype 9V, 1 Year Post Vax 2
221
(139.8 to 350.8)
224
(155.9 to 321.6)
139
(90.6 to 213.1)
Serotype 14, 1 Month Post Vax 2
434
(311.6 to 605.6)
639
(487.8 to 836.3)
426
(312.7 to 580.5)
Serotype 14, 1 Year Post Vax 2
380
(273.4 to 528.8)
406
(306.7 to 537.0)
388
(290.7 to 517.2)
Serotype 18C, 1 Month Post Vax 2
972
(732.4 to 1290.1)
1092
(879.6 to 1356.2)
549
(395.9 to 761.1)
Serotype 18C, 1 Year Post Vax 2
373
(255.6 to 544.2)
513
(389.6 to 676.7)
331
(235.3 to 467.0)
Serotype 19A, 1 Month Post Vax 2
365
(295.0 to 450.7)
513
(445.6 to 590.5)
282
(230.3 to 344.4)
Serotype 19A, 1 Year Post Vax 2
213
(163.6 to 276.3)
295
(246.6 to 352.7)
167
(132.0 to 210.5)
Serotype 19F, 1 Month Post Vax 2
493
(365.0 to 664.7)
835
(685.5 to 1015.9)
264
(196.3 to 355.8)
Serotype 19F, 1 Year Post Vax 2
255
(180.5 to 360.8)
425
(340.9 to 529.2)
197
(146.4 to 266.2)
Serotype 23F, 1 Month Post Vax 2
543
(392.9 to 749.4)
218
(164.8 to 288.0)
109
(76.4 to 156.2)
Serotype 23F, 1 Year Post Vax 2
108
(71.9 to 162.3)
63
(46.4 to 84.5)
38
(27.1 to 52.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.32 to 0.46
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.30 to 0.41
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.44 to 0.61
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.17 to 0.25
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.18 to 0.24
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.31 to 0.41
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.19 to 0.32
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.22 to 0.33
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.17 to 0.30
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.25 to 0.39
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.27 to 0.38
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.44 to 0.60
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.10 to 0.20
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.17 to 0.25
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.09 to 0.16
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.41 to 0.62
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.43 to 0.62
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.38 to 0.59
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.60 to 1.00
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.51 to 0.75
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.86 to 1.46
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.41 to 0.80
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.39 to 0.73
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.78 to 1.67
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.71 to 1.08
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.54 to 0.75
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.78 to 1.06
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.29 to 0.51
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.39 to 0.56
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.53 to 0.69
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.49 to 0.69
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.52 to 0.63
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.53 to 0.66
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.42 to 0.64
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.44 to 0.60
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.63 to 0.88
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.15 to 0.26
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.23 to 0.35
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.28 to 0.43
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
4.Secondary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Hide Arm/Group Description:
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 216 217
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1, 1 Month Post Vax 2
80
(65.0 to 97.7)
34
(27.2 to 43.7)
Serotype 1, 1 Year Post Vax 2
39
(31.1 to 48.2)
22
(17.4 to 27.6)
Serotype 3, 1 Month Post Vax 2
50
(42.1 to 59.2)
32
(26.1 to 38.9)
Serotype 3, 1 Year Post Vax 2
20
(16.5 to 23.6)
16
(13.2 to 19.1)
Serotype 4, 1 Month Post Vax 2
437
(332.0 to 576.3)
237
(173.5 to 325.1)
Serotype 4, 1 Year Post Vax 2
311
(238.1 to 407.1)
186
(138.3 to 250.2)
Serotype 5, 1 Month Post Vax 2
62
(48.1 to 79.4)
49
(37.4 to 63.7)
Serotype 5, 1 Year Post Vax 2
58
(45.0 to 74.4)
42
(31.7 to 54.8)
Serotype 6A, 1 Month Post Vax 2
1088
(843.2 to 1404.7)
569
(421.8 to 768.5)
Serotype 6A, 1 Year Post Vax 2
257
(192.4 to 342.9)
133
(97.4 to 182.1)
Serotype 6B, 1 Month Post Vax 2
1516
(1173.7 to 1957.5)
781
(574.8 to 1061.9)
Serotype 6B, 1 Year Post Vax 2
561
(421.4 to 746.9)
381
(282.6 to 514.5)
Serotype 7F, 1 Month Post Vax 2
233
(166.5 to 324.8)
135
(93.2 to 194.5)
Serotype 7F, 1 Year Post Vax 2
173
(125.9 to 239.1)
117
(82.8 to 165.4)
Serotype 9V, 1 Month Post Vax 2
166
(113.8 to 241.5)
91
(62.0 to 133.3)
Serotype 9V, 1 Year Post Vax 2
83
(56.2 to 121.9)
73
(49.9 to 105.9)
Serotype 14, 1 Month Post Vax 2
216
(163.8 to 284.3)
199
(146.9 to 270.8)
Serotype 14, 1 Year Post Vax 2
209
(159.5 to 272.9)
244
(184.5 to 321.9)
Serotype 18C, 1 Month Post Vax 2
1015
(832.6 to 1237.6)
523
(395.1 to 693.5)
Serotype 18C, 1 Year Post Vax 2
553
(446.5 to 685.6)
366
(277.2 to 482.9)
Serotype 19A, 1 Month Post Vax 2
356
(297.6 to 425.6)
255
(207.8 to 313.7)
Serotype 19A, 1 Year Post Vax 2
228
(189.1 to 276.1)
182
(147.7 to 225.2)
Serotype 19F, 1 Month Post Vax 2
349
(274.7 to 444.5)
178
(134.1 to 235.0)
Serotype 19F, 1 Year Post Vax 2
274
(214.2 to 350.8)
158
(119.1 to 210.6)
Serotype 23F, 1 Month Post Vax 2
324
(250.8 to 419.8)
113
(82.4 to 154.8)
Serotype 23F, 1 Year Post Vax 2
102
(77.0 to 135.0)
46
(33.9 to 61.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.42 to 0.56
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.56 to 0.72
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.35 to 0.45
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.44 to 0.57
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.60 to 0.85
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.63 to 0.97
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.81 to 1.08
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.74 to 0.99
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.19 to 0.29
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.19 to 0.29
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.31 to 0.45
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.40 to 0.59
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.58 to 0.96
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.67 to 1.13
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.37 to 0.67
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.57 to 1.12
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.85 to 1.09
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.04 to 1.43
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.48 to 0.62
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.59 to 0.83
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.57 to 0.72
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.65 to 0.79
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.66 to 0.93
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.75 to 1.05
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.27 to 0.37
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.34 to 0.48
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
5.Secondary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve)
Hide Arm/Group Description:
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 124 204 173
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1, Pre Vax 2
52
(38.2 to 69.5)
56
(44.4 to 70.6)
44
(33.0 to 57.7)
Serotype 1, 1 Year Post Vax 2
52
(39.6 to 69.0)
50
(39.7 to 63.9)
34
(26.2 to 45.1)
Serotype 3, Pre Vax 2
19
(14.5 to 24.1)
23
(18.6 to 28.1)
26
(20.3 to 32.4)
Serotype 3, 1 Year Post Vax 2
18
(14.2 to 22.3)
26
(21.4 to 31.6)
18
(14.7 to 22.4)
Serotype 4, Pre Vax 2
710
(504.4 to 998.7)
591
(437.9 to 798.0)
350
(242.0 to 506.6)
Serotype 4, 1 Year Post Vax 2
376
(264.2 to 534.0)
414
(312.3 to 548.2)
209
(144.6 to 302.1)
Serotype 5, Pre Vax 2
39
(26.2 to 56.7)
66
(48.9 to 87.8)
49
(36.4 to 67.1)
Serotype 5, 1 Year Post Vax 2
29
(20.4 to 42.1)
73
(55.3 to 96.4)
43
(31.9 to 58.2)
Serotype 6A, Pre Vax 2
540
(347.1 to 838.8)
656
(484.0 to 888.4)
85
(56.3 to 127.7)
Serotype 6A, 1 Year Post Vax 2
331
(227.1 to 483.3)
251
(183.4 to 343.3)
108
(74.7 to 157.3)
Serotype 6B, Pre Vax 2
459
(292.2 to 719.9)
430
(304.8 to 605.6)
192
(128.4 to 286.0)
Serotype 6B, 1 Year Post Vax 2
781
(529.8 to 1150.8)
580
(427.9 to 786.8)
298
(203.8 to 435.6)
Serotype 7F, Pre Vax 2
146
(89.4 to 237.1)
133
(92.4 to 191.0)
71
(46.9 to 107.6)
Serotype 7F, 1 Year Post Vax 2
244
(155.7 to 383.4)
414
(313.8 to 546.5)
146
(99.7 to 212.8)
Serotype 9V, Pre Vax 2
96
(58.3 to 158.4)
79
(53.2 to 116.2)
50
(32.4 to 78.5)
Serotype 9V, 1 Year Post Vax 2
201
(125.8 to 320.2)
212
(147.4 to 306.4)
147
(95.8 to 226.8)
Serotype 14, Pre Vax 2
241
(159.6 to 364.0)
290
(208.6 to 403.1)
302
(214.2 to 425.3)
Serotype 14, 1 Year Post Vax 2
383
(274.1 to 534.2)
420
(317.0 to 556.1)
367
(272.9 to 493.4)
Serotype 18C, Pre Vax 2
403
(273.8 to 592.0)
462
(346.1 to 615.8)
339
(236.2 to 487.4)
Serotype 18C, 1 Year Post Vax 2
398
(274.1 to 579.1)
513
(389.5 to 676.1)
349
(247.8 to 492.2)
Serotype 19A, Pre Vax 2
203
(151.3 to 271.8)
209
(170.3 to 257.6)
153
(117.3 to 199.5)
Serotype 19A, 1 Year Post Vax 2
253
(197.2 to 325.7)
296
(248.3 to 353.0)
169
(133.0 to 214.6)
Serotype 19F, Pre Vax 2
114
(72.7 to 177.5)
183
(135.0 to 247.7)
127
(89.7 to 180.1)
Serotype 19F, 1 Year Post Vax 2
238
(165.2 to 341.7)
419
(334.2 to 524.2)
190
(139.8 to 258.7)
Serotype 23F, Pre Vax 2
90
(58.5 to 139.9)
90
(65.4 to 123.6)
30
(21.2 to 42.1)
Serotype 23F, 1 Year Post Vax 2
104
(67.9 to 158.6)
66
(48.7 to 88.9)
36
(26.3 to 50.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.85 to 1.22
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.79 to 1.02
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.69 to 0.90
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.82 to 1.10
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.98 to 1.32
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.62 to 0.81
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.41 to 0.69
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.60 to 0.82
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.47 to 0.76
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.67 to 0.87
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.96 to 1.30
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.75 to 1.02
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.48 to 0.79
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.32 to 0.46
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.94 to 1.75
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.32 to 2.19
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.14 to 1.60
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.20 to 2.01
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.24 to 2.26
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
2.26 to 4.30
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
1.53 to 2.75
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.48 to 2.95
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
1.97 to 3.70
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
1.99 to 4.29
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.23 to 2.05
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.18 to 1.78
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.04 to 1.42
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.82 to 1.19
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.96 to 1.29
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.89 to 1.20
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.07 to 1.46
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.24 to 1.61
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.96 to 1.27
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rises
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.56 to 2.80
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.82 to 2.88
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.18 to 1.90
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.89 to 1.48
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.63 to 0.85
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.99 to 1.51
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
6.Secondary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Hide Arm/Group Description:
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 217 219
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1, Pre Vax 2
33
(26.4 to 41.1)
21
(17.1 to 26.9)
Serotype 1, 1 Year Post Vax 2
38
(30.7 to 47.5)
22
(17.5 to 27.8)
Serotype 3, Pre Vax 2
16
(13.2 to 19.4)
16
(13.0 to 19.4)
Serotype 3, 1 Year Post Vax 2
19
(16.2 to 23.2)
16
(13.3 to 19.4)
Serotype 4, Pre Vax 2
129
(89.0 to 186.9)
73
(50.4 to 104.7)
Serotype 4, 1 Year Post Vax 2
267
(198.8 to 358.8)
177
(129.9 to 240.0)
Serotype 5, Pre Vax 2
32
(25.0 to 41.4)
24
(18.0 to 30.8)
Serotype 5, 1 Year Post Vax 2
57
(44.5 to 73.2)
42
(32.2 to 55.6)
Serotype 6A, Pre Vax 2
279
(203.4 to 383.4)
58
(41.9 to 81.1)
Serotype 6A, 1 Year Post Vax 2
256
(191.2 to 341.9)
113
(82.5 to 155.2)
Serotype 6B, Pre Vax 2
403
(290.6 to 558.3)
186
(131.1 to 264.3)
Serotype 6B, 1 Year Post Vax 2
511
(376.9 to 693.4)
361
(263.4 to 495.7)
Serotype 7F, Pre Vax 2
66
(46.3 to 95.3)
66
(45.5 to 95.0)
Serotype 7F, 1 Year Post Vax 2
175
(127.1 to 240.3)
111
(78.4 to 157.4)
Serotype 9V, Pre Vax 2
40
(27.6 to 59.1)
28
(19.7 to 40.6)
Serotype 9V, 1 Year Post Vax 2
76
(51.6 to 112.9)
69
(47.3 to 100.9)
Serotype 14, Pre Vax 2
130
(96.1 to 176.2)
144
(104.7 to 198.7)
Serotype 14, 1 Year Post Vax 2
204
(155.6 to 268.5)
240
(180.7 to 319.3)
Serotype 18C, Pre Vax 2
436
(340.9 to 556.7)
271
(197.8 to 371.7)
Serotype 18C, 1 Year Post Vax 2
545
(438.2 to 678.0)
360
(272.5 to 475.9)
Serotype 19A, Pre Vax 2
185
(152.8 to 222.9)
124
(97.4 to 158.3)
Serotype 19A, 1 Year Post Vax 2
235
(196.4 to 282.2)
181
(146.7 to 223.8)
Serotype 19F, Pre Vax 2
121
(91.1 to 160.0)
84
(61.6 to 115.4)
Serotype 19F, 1 Year Post Vax 2
261
(204.9 to 333.7)
159
(119.0 to 211.4)
Serotype 23F, Pre Vax 2
60
(44.5 to 81.1)
30
(22.3 to 41.0)
Serotype 23F, 1 Year Post Vax 2
104
(78.0 to 137.4)
46
(33.9 to 61.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.03 to 1.31
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.91 to 1.16
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.07 to 1.37
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.91 to 1.13
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.60 to 2.68
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.82 to 3.24
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
1.55 to 2.03
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
1.54 to 2.09
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.79 to 1.07
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.48 to 2.55
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.05 to 1.53
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.50 to 2.51
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.98 to 3.50
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.31 to 2.18
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.37 to 2.61
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.76 to 3.38
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.33 to 1.86
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.38 to 2.01
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.10 to 1.42
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.14 to 1.55
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.14 to 1.43
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.28 to 1.67
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.80 to 2.60
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.53 to 2.31
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.44 to 2.06
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Comments Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
1.24 to 1.84
Estimation Comments Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
7.Secondary Outcome
Title Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Hide Description Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Arm/Group Title 13vPnC/13vPnC Group (23vPS Naïve) 13vPnC/23vPS Group (23vPS Naïve) 23vPS/13vPnC Group (23vPS Naïve)
Hide Arm/Group Description:
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed 127 199 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serotype 1, 1 Month Post Vax 1
229
(176.7 to 295.9)
228
(185.8 to 280.7)
147
(112.6 to 192.0)
Serotype 1, 1 Year Post Vax 2
54
(40.6 to 71.4)
47
(37.5 to 60.0)
35
(26.6 to 46.3)
Serotype 3, 1 Month Post Vax 1
75
(59.1 to 95.5)
75
(61.6 to 91.6)
85
(69.0 to 103.9)
Serotype 3, 1 Year Post Vax 2
19
(14.8 to 23.3)
27
(22.5 to 32.8)
18
(14.8 to 22.5)
Serotype 4, 1 Month Post Vax 1
2546
(1908.6 to 3395.8)
2575
(2075.2 to 3195.9)
1406
(1026.6 to 1926.5)
Serotype 4, 1 Year Post Vax 2
346
(242.6 to 493.7)
405
(304.4 to 538.3)
184
(127.1 to 267.4)
Serotype 5, 1 Month Post Vax 1
153
(101.6 to 229.5)
255
(190.1 to 341.4)
145
(106.8 to 197.9)
Serotype 5, 1 Year Post Vax 2
26
(18.5 to 37.8)
69
(52.4 to 91.8)
45
(33.6 to 61.0)
Serotype 6A, 1 Month Post Vax 1
2757
(2027.3 to 3750.3)
3022
(2356.7 to 3875.6)
335
(227.3 to 494.8)
Serotype 6A, 1 Year Post Vax 2
286
(195.1 to 418.1)
235
(171.4 to 320.9)
105
(73.1 to 152.2)
Serotype 6B, 1 Month Post Vax 1
1739
(1176.0 to 2570.2)
1969
(1512.1 to 2562.7)
767
(545.3 to 1080.0)
Serotype 6B, 1 Year Post Vax 2
855
(595.2 to 1227.5)
697
(523.9 to 926.4)
319
(220.5 to 462.1)
Serotype 7F, 1 Month Post Vax 1
906
(590.6 to 1388.7)
1459
(1147.2 to 1855.1)
365
(243.8 to 546.8)
Serotype 7F, 1 Year Post Vax 2
231
(148.8 to 359.6)
398
(301.1 to 527.0)
143
(97.9 to 208.2)
Serotype 9V, 1 Month Post Vax 1
1055
(740.6 to 1502.7)
801
(589.0 to 1090.0)
294
(192.2 to 449.9)
Serotype 9V, 1 Year Post Vax 2
203
(127.4 to 322.0)
224
(155.1 to 322.3)
127
(82.5 to 196.0)
Serotype 14, 1 Month Post Vax 1
614
(409.0 to 921.9)
727
(527.6 to 1000.7)
748
(535.4 to 1045.9)
Serotype 14, 1 Year Post Vax 2
387
(277.1 to 540.7)
435
(329.4 to 575.6)
391
(291.9 to 524.8)
Serotype 18C, 1 Month Post Vax 1
1603
(1153.7 to 2226.2)
1614
(1230.2 to 2117.7)
888
(639.0 to 1233.2)
Serotype 18C, 1 Year Post Vax 2
409
(281.0 to 596.0)
560
(424.2 to 739.8)
323
(227.9 to 457.0)
Serotype 19A, 1 Month Post Vax 1
698
(522.4 to 932.2)
781
(662.0 to 920.4)
380
(296.6 to 486.6)
Serotype 19A, 1 Year Post Vax 2
243
(185.7 to 319.1)
310
(260.8 to 369.0)
162
(126.7 to 207.7)
Serotype 19F, 1 Month Post Vax 1
530
(361.7 to 775.7)
845
(661.8 to 1079.9)
423
(302.2 to 591.4)
Serotype 19F, 1 Year Post Vax 2
239
(166.7 to 342.6)
416
(333.0 to 519.7)
180
(131.7 to 245.7)
Serotype 23F, 1 Month Post Vax 1
339
(219.9 to 521.8)
367
(268.3 to 501.2)
72
(49.1 to 104.7)
Serotype 23F, 1 Year Post Vax 2
105
(69.5 to 159.3)
70
(52.0 to 95.0)
39
(27.6 to 53.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.19 to 0.29
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.17 to 0.25
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.20 to 0.29
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.20 to 0.30
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.31 to 0.42
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.18 to 0.26
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.10 to 0.18
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.12 to 0.20
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.10 to 0.18
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.13 to 0.22
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC/23vPS Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.22 to 0.33
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 23vPS/13vPnC Group (23vPS Naïve)
Comments Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean fold rise
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.25 to 0.38
Estimation Comments CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC/13vPnC Group (23vPS Naïve)
Comments Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
Type of