Trial Outcomes & Findings for Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated (NCT NCT01025336)
NCT ID: NCT01025336
Last Updated: 2012-06-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
962 participants
Primary outcome timeframe
Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)
Results posted on
2012-06-20
Participant Flow
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).
Participant milestones
| Measure |
13vPnC/13vPnC Group (23vPS Naïve)
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)
|
13vPnC/23vPS Group (23vPS Naïve)
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
130
|
210
|
179
|
221
|
222
|
|
Overall Study
COMPLETED
|
130
|
210
|
179
|
219
|
222
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
13vPnC/13vPnC Group (23vPS Naïve)
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)
|
13vPnC/23vPS Group (23vPS Naïve)
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated
Baseline characteristics by cohort
| Measure |
13vPnC/13vPnC Group (23vPS Naïve)
n=130 Participants
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)
|
13vPnC/23vPS Group (23vPS Naïve)
n=210 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=179 Participants
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)
|
13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=221 Participants
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)
|
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=222 Participants
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
n=962 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
64.0 Years
STANDARD_DEVIATION 1.4 • n=93 Participants
|
64.1 Years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
64.2 Years
STANDARD_DEVIATION 1.4 • n=27 Participants
|
78.3 Years
STANDARD_DEVIATION 4.5 • n=483 Participants
|
77.8 Years
STANDARD_DEVIATION 4.1 • n=36 Participants
|
70.5 Years
STANDARD_DEVIATION 7.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
114 Participants
n=483 Participants
|
115 Participants
n=36 Participants
|
532 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
107 Participants
n=483 Participants
|
107 Participants
n=36 Participants
|
430 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=209 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=129 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=179 Participants
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 19A
|
313 titer
Interval 263.1 to 372.3
|
244 titer
Interval 189.1 to 314.1
|
170 titer
Interval 134.4 to 214.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 1
|
52 titer
Interval 40.9 to 65.5
|
54 titer
Interval 40.8 to 71.0
|
36 titer
Interval 27.1 to 46.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 3
|
27 titer
Interval 22.2 to 32.3
|
19 titer
Interval 15.0 to 23.5
|
18 titer
Interval 14.4 to 21.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 4
|
355 titer
Interval 264.7 to 475.9
|
328 titer
Interval 229.0 to 469.0
|
183 titer
Interval 127.7 to 263.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 5
|
76 titer
Interval 58.0 to 99.7
|
29 titer
Interval 20.4 to 41.4
|
44 titer
Interval 32.9 to 59.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 18C
|
527 titer
Interval 401.7 to 690.5
|
393 titer
Interval 271.3 to 569.3
|
337 titer
Interval 240.7 to 471.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 6A
|
225 titer
Interval 163.6 to 308.3
|
316 titer
Interval 216.5 to 461.2
|
102 titer
Interval 71.4 to 146.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 6B
|
593 titer
Interval 441.4 to 797.3
|
785 titer
Interval 540.6 to 1140.2
|
324 titer
Interval 225.0 to 466.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 7F
|
412 titer
Interval 313.1 to 541.2
|
247 titer
Interval 160.4 to 380.9
|
145 titer
Interval 100.3 to 210.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 9V
|
221 titer
Interval 154.2 to 316.0
|
211 titer
Interval 134.3 to 330.9
|
129 titer
Interval 84.5 to 196.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 14
|
416 titer
Interval 316.2 to 548.2
|
379 titer
Interval 273.6 to 526.2
|
383 titer
Interval 286.9 to 510.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 19F
|
426 titer
Interval 343.7 to 527.7
|
256 titer
Interval 182.4 to 359.0
|
195 titer
Interval 145.1 to 262.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Serotype 23F
|
64 titer
Interval 47.6 to 86.5
|
110 titer
Interval 73.9 to 165.0
|
35 titer
Interval 25.6 to 48.6
|
PRIMARY outcome
Timeframe: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=222 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=220 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 1
|
22 titer
Interval 17.5 to 27.8
|
38 titer
Interval 30.9 to 47.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 3
|
16 titer
Interval 13.3 to 19.2
|
20 titer
Interval 16.5 to 23.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 4
|
172 titer
Interval 129.0 to 230.1
|
265 titer
Interval 200.8 to 348.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 7F
|
115 titer
Interval 81.6 to 160.9
|
173 titer
Interval 126.0 to 237.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 5
|
42 titer
Interval 32.2 to 55.6
|
58 titer
Interval 45.1 to 74.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 6A
|
115 titer
Interval 84.5 to 156.8
|
250 titer
Interval 187.3 to 334.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 6B
|
381 titer
Interval 281.9 to 513.9
|
510 titer
Interval 378.2 to 686.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 9V
|
68 titer
Interval 47.4 to 98.5
|
81 titer
Interval 55.1 to 117.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 14
|
240 titer
Interval 181.0 to 317.0
|
202 titer
Interval 154.6 to 265.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 18C
|
360 titer
Interval 273.6 to 474.5
|
540 titer
Interval 435.5 to 668.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 19A
|
181 titer
Interval 146.7 to 222.9
|
232 titer
Interval 193.2 to 278.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 19F
|
158 titer
Interval 119.3 to 209.9
|
277 titer
Interval 218.6 to 351.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 23F
|
45 titer
Interval 33.5 to 59.6
|
103 titer
Interval 78.0 to 135.5
|
—
|
SECONDARY outcome
Timeframe: Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=204 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=126 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=175 Participants
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Month Post Vax 2
|
149 titer
Interval 123.5 to 180.6
|
141 titer
Interval 110.4 to 179.7
|
70 titer
Interval 53.4 to 91.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Year Post Vax 2
|
52 titer
Interval 41.1 to 66.1
|
54 titer
Interval 40.7 to 70.4
|
36 titer
Interval 27.6 to 47.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Month Post Vax 2
|
130 titer
Interval 112.8 to 150.3
|
87 titer
Interval 73.7 to 103.8
|
50 titer
Interval 40.2 to 63.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Year Post Vax 2
|
27 titer
Interval 22.2 to 32.5
|
18 titer
Interval 14.6 to 22.9
|
18 titer
Interval 14.5 to 22.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Month Post Vax 2
|
1375 titer
Interval 1137.0 to 1663.8
|
1284 titer
Interval 992.3 to 1661.9
|
898 titer
Interval 684.1 to 1179.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Year Post Vax 2
|
369 titer
Interval 276.1 to 493.9
|
318 titer
Interval 220.9 to 458.7
|
203 titer
Interval 142.0 to 291.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Month Post Vax 2
|
223 titer
Interval 180.7 to 276.3
|
95 titer
Interval 67.1 to 133.2
|
80 titer
Interval 59.7 to 108.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Year Post Vax 2
|
72 titer
Interval 54.6 to 95.1
|
29 titer
Interval 20.3 to 42.5
|
41 titer
Interval 30.3 to 56.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Month Post Vax 2
|
1307 titer
Interval 1021.4 to 1672.8
|
2120 titer
Interval 1614.1 to 2783.9
|
933 titer
Interval 682.1 to 1276.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Year Post Vax 2
|
266 titer
Interval 195.2 to 362.6
|
304 titer
Interval 207.7 to 446.3
|
115 titer
Interval 79.3 to 166.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Month Post Vax 2
|
1232 titer
Interval 965.9 to 1570.4
|
1683 titer
Interval 1253.6 to 2258.3
|
740 titer
Interval 534.8 to 1024.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Year Post Vax 2
|
637 titer
Interval 476.3 to 851.6
|
847 titer
Interval 590.8 to 1214.8
|
352 titer
Interval 244.8 to 505.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Month Post Vax 2
|
667 titer
Interval 531.5 to 836.8
|
306 titer
Interval 201.8 to 462.5
|
131 titer
Interval 87.8 to 496.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Year Post Vax 2
|
412 titer
Interval 313.2 to 541.5
|
237 titer
Interval 152.2 to 369.9
|
148 titer
Interval 101.4 to 215.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Month Post Vax 2
|
419 titer
Interval 298.6 to 588.0
|
385 titer
Interval 252.6 to 586.8
|
122 titer
Interval 80.0 to 186.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Year Post Vax 2
|
224 titer
Interval 155.9 to 321.6
|
221 titer
Interval 139.8 to 350.8
|
139 titer
Interval 90.6 to 213.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Month Post Vax 2
|
639 titer
Interval 487.8 to 836.3
|
434 titer
Interval 311.6 to 605.6
|
426 titer
Interval 312.7 to 580.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Year Post Vax 2
|
406 titer
Interval 306.7 to 537.0
|
380 titer
Interval 273.4 to 528.8
|
388 titer
Interval 290.7 to 517.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Month Post Vax 2
|
1092 titer
Interval 879.6 to 1356.2
|
972 titer
Interval 732.4 to 1290.1
|
549 titer
Interval 395.9 to 761.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Year Post Vax 2
|
513 titer
Interval 389.6 to 676.7
|
373 titer
Interval 255.6 to 544.2
|
331 titer
Interval 235.3 to 467.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Month Post Vax 2
|
513 titer
Interval 445.6 to 590.5
|
365 titer
Interval 295.0 to 450.7
|
282 titer
Interval 230.3 to 344.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Year Post Vax 2
|
295 titer
Interval 246.6 to 352.7
|
213 titer
Interval 163.6 to 276.3
|
167 titer
Interval 132.0 to 210.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Month Post Vax 2
|
835 titer
Interval 685.5 to 1015.9
|
493 titer
Interval 365.0 to 664.7
|
264 titer
Interval 196.3 to 355.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Year Post Vax 2
|
425 titer
Interval 340.9 to 529.2
|
255 titer
Interval 180.5 to 360.8
|
197 titer
Interval 146.4 to 266.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Month Post Vax 2
|
218 titer
Interval 164.8 to 288.0
|
543 titer
Interval 392.9 to 749.4
|
109 titer
Interval 76.4 to 156.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Year Post Vax 2
|
63 titer
Interval 46.4 to 84.5
|
108 titer
Interval 71.9 to 162.3
|
38 titer
Interval 27.1 to 52.2
|
SECONDARY outcome
Timeframe: Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=217 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=216 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Month Post Vax 2
|
34 titer
Interval 27.2 to 43.7
|
80 titer
Interval 65.0 to 97.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Year Post Vax 2
|
22 titer
Interval 17.4 to 27.6
|
39 titer
Interval 31.1 to 48.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Month Post Vax 2
|
32 titer
Interval 26.1 to 38.9
|
50 titer
Interval 42.1 to 59.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Year Post Vax 2
|
16 titer
Interval 13.2 to 19.1
|
20 titer
Interval 16.5 to 23.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Month Post Vax 2
|
237 titer
Interval 173.5 to 325.1
|
437 titer
Interval 332.0 to 576.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Year Post Vax 2
|
186 titer
Interval 138.3 to 250.2
|
311 titer
Interval 238.1 to 407.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Month Post Vax 2
|
49 titer
Interval 37.4 to 63.7
|
62 titer
Interval 48.1 to 79.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
42 titer
Interval 31.7 to 54.8
|
58 titer
Interval 45.0 to 74.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Month Post Vax 2
|
569 titer
Interval 421.8 to 768.5
|
1088 titer
Interval 843.2 to 1404.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Year Post Vax 2
|
133 titer
Interval 97.4 to 182.1
|
257 titer
Interval 192.4 to 342.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Month Post Vax 2
|
781 titer
Interval 574.8 to 1061.9
|
1516 titer
Interval 1173.7 to 1957.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Year Post Vax 2
|
381 titer
Interval 282.6 to 514.5
|
561 titer
Interval 421.4 to 746.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Month Post Vax 2
|
135 titer
Interval 93.2 to 194.5
|
233 titer
Interval 166.5 to 324.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Year Post Vax 2
|
117 titer
Interval 82.8 to 165.4
|
173 titer
Interval 125.9 to 239.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Month Post Vax 2
|
91 titer
Interval 62.0 to 133.3
|
166 titer
Interval 113.8 to 241.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
73 titer
Interval 49.9 to 105.9
|
83 titer
Interval 56.2 to 121.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Month Post Vax 2
|
199 titer
Interval 146.9 to 270.8
|
216 titer
Interval 163.8 to 284.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Year Post Vax 2
|
244 titer
Interval 184.5 to 321.9
|
209 titer
Interval 159.5 to 272.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Month Post Vax 2
|
523 titer
Interval 395.1 to 693.5
|
1015 titer
Interval 832.6 to 1237.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Year Post Vax 2
|
366 titer
Interval 277.2 to 482.9
|
553 titer
Interval 446.5 to 685.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Month Post Vax 2
|
255 titer
Interval 207.8 to 313.7
|
356 titer
Interval 297.6 to 425.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Year Post Vax 2
|
182 titer
Interval 147.7 to 225.2
|
228 titer
Interval 189.1 to 276.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Month Post Vax 2
|
178 titer
Interval 134.1 to 235.0
|
349 titer
Interval 274.7 to 444.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Year Post Vax 2
|
158 titer
Interval 119.1 to 210.6
|
274 titer
Interval 214.2 to 350.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Month Post Vax 2
|
113 titer
Interval 82.4 to 154.8
|
324 titer
Interval 250.8 to 419.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Year Post Vax 2
|
46 titer
Interval 33.9 to 61.7
|
102 titer
Interval 77.0 to 135.0
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=204 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=124 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=173 Participants
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Year Post Vax 2
|
420 titer
Interval 317.0 to 556.1
|
383 titer
Interval 274.1 to 534.2
|
367 titer
Interval 272.9 to 493.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, Pre Vax 2
|
462 titer
Interval 346.1 to 615.8
|
403 titer
Interval 273.8 to 592.0
|
339 titer
Interval 236.2 to 487.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, Pre Vax 2
|
290 titer
Interval 208.6 to 403.1
|
241 titer
Interval 159.6 to 364.0
|
302 titer
Interval 214.2 to 425.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, Pre Vax 2
|
56 titer
Interval 44.4 to 70.6
|
52 titer
Interval 38.2 to 69.5
|
44 titer
Interval 33.0 to 57.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Year Post Vax 2
|
50 titer
Interval 39.7 to 63.9
|
52 titer
Interval 39.6 to 69.0
|
34 titer
Interval 26.2 to 45.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, Pre Vax 2
|
23 titer
Interval 18.6 to 28.1
|
19 titer
Interval 14.5 to 24.1
|
26 titer
Interval 20.3 to 32.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Year Post Vax 2
|
26 titer
Interval 21.4 to 31.6
|
18 titer
Interval 14.2 to 22.3
|
18 titer
Interval 14.7 to 22.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, Pre Vax 2
|
591 titer
Interval 437.9 to 798.0
|
710 titer
Interval 504.4 to 998.7
|
350 titer
Interval 242.0 to 506.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Year Post Vax 2
|
414 titer
Interval 312.3 to 548.2
|
376 titer
Interval 264.2 to 534.0
|
209 titer
Interval 144.6 to 302.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, Pre Vax 2
|
66 titer
Interval 48.9 to 87.8
|
39 titer
Interval 26.2 to 56.7
|
49 titer
Interval 36.4 to 67.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Year Post Vax 2
|
73 titer
Interval 55.3 to 96.4
|
29 titer
Interval 20.4 to 42.1
|
43 titer
Interval 31.9 to 58.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, Pre Vax 2
|
656 titer
Interval 484.0 to 888.4
|
540 titer
Interval 347.1 to 838.8
|
85 titer
Interval 56.3 to 127.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Year Post Vax 2
|
251 titer
Interval 183.4 to 343.3
|
331 titer
Interval 227.1 to 483.3
|
108 titer
Interval 74.7 to 157.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, Pre Vax 2
|
430 titer
Interval 304.8 to 605.6
|
459 titer
Interval 292.2 to 719.9
|
192 titer
Interval 128.4 to 286.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Year Post Vax 2
|
580 titer
Interval 427.9 to 786.8
|
781 titer
Interval 529.8 to 1150.8
|
298 titer
Interval 203.8 to 435.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, Pre Vax 2
|
133 titer
Interval 92.4 to 191.0
|
146 titer
Interval 89.4 to 237.1
|
71 titer
Interval 46.9 to 107.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Year Post Vax 2
|
414 titer
Interval 313.8 to 546.5
|
244 titer
Interval 155.7 to 383.4
|
146 titer
Interval 99.7 to 212.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, Pre Vax 2
|
79 titer
Interval 53.2 to 116.2
|
96 titer
Interval 58.3 to 158.4
|
50 titer
Interval 32.4 to 78.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Year Post Vax 2
|
212 titer
Interval 147.4 to 306.4
|
201 titer
Interval 125.8 to 320.2
|
147 titer
Interval 95.8 to 226.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Year Post Vax 2
|
513 titer
Interval 389.5 to 676.1
|
398 titer
Interval 274.1 to 579.1
|
349 titer
Interval 247.8 to 492.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, Pre Vax 2
|
209 titer
Interval 170.3 to 257.6
|
203 titer
Interval 151.3 to 271.8
|
153 titer
Interval 117.3 to 199.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Year Post Vax 2
|
296 titer
Interval 248.3 to 353.0
|
253 titer
Interval 197.2 to 325.7
|
169 titer
Interval 133.0 to 214.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, Pre Vax 2
|
183 titer
Interval 135.0 to 247.7
|
114 titer
Interval 72.7 to 177.5
|
127 titer
Interval 89.7 to 180.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Year Post Vax 2
|
419 titer
Interval 334.2 to 524.2
|
238 titer
Interval 165.2 to 341.7
|
190 titer
Interval 139.8 to 258.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, Pre Vax 2
|
90 titer
Interval 65.4 to 123.6
|
90 titer
Interval 58.5 to 139.9
|
30 titer
Interval 21.2 to 42.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Year Post Vax 2
|
66 titer
Interval 48.7 to 88.9
|
104 titer
Interval 67.9 to 158.6
|
36 titer
Interval 26.3 to 50.6
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=219 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=217 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Year Post Vax 2
|
111 titer
Interval 78.4 to 157.4
|
175 titer
Interval 127.1 to 240.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, Pre Vax 2
|
28 titer
Interval 19.7 to 40.6
|
40 titer
Interval 27.6 to 59.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
69 titer
Interval 47.3 to 100.9
|
76 titer
Interval 51.6 to 112.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, Pre Vax 2
|
144 titer
Interval 104.7 to 198.7
|
130 titer
Interval 96.1 to 176.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Year Post Vax 2
|
240 titer
Interval 180.7 to 319.3
|
204 titer
Interval 155.6 to 268.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, Pre Vax 2
|
271 titer
Interval 197.8 to 371.7
|
436 titer
Interval 340.9 to 556.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Year Post Vax 2
|
360 titer
Interval 272.5 to 475.9
|
545 titer
Interval 438.2 to 678.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, Pre Vax 2
|
124 titer
Interval 97.4 to 158.3
|
185 titer
Interval 152.8 to 222.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Year Post Vax 2
|
181 titer
Interval 146.7 to 223.8
|
235 titer
Interval 196.4 to 282.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, Pre Vax 2
|
84 titer
Interval 61.6 to 115.4
|
121 titer
Interval 91.1 to 160.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Year Post Vax 2
|
159 titer
Interval 119.0 to 211.4
|
261 titer
Interval 204.9 to 333.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, Pre Vax 2
|
30 titer
Interval 22.3 to 41.0
|
60 titer
Interval 44.5 to 81.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Year Post Vax 2
|
46 titer
Interval 33.9 to 61.8
|
104 titer
Interval 78.0 to 137.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, Pre Vax 2
|
21 titer
Interval 17.1 to 26.9
|
33 titer
Interval 26.4 to 41.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Year Post Vax 2
|
22 titer
Interval 17.5 to 27.8
|
38 titer
Interval 30.7 to 47.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, Pre Vax 2
|
16 titer
Interval 13.0 to 19.4
|
16 titer
Interval 13.2 to 19.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Year Post Vax 2
|
16 titer
Interval 13.3 to 19.4
|
19 titer
Interval 16.2 to 23.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, Pre Vax 2
|
73 titer
Interval 50.4 to 104.7
|
129 titer
Interval 89.0 to 186.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Year Post Vax 2
|
177 titer
Interval 129.9 to 240.0
|
267 titer
Interval 198.8 to 358.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, Pre Vax 2
|
24 titer
Interval 18.0 to 30.8
|
32 titer
Interval 25.0 to 41.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
42 titer
Interval 32.2 to 55.6
|
57 titer
Interval 44.5 to 73.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, Pre Vax 2
|
58 titer
Interval 41.9 to 81.1
|
279 titer
Interval 203.4 to 383.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Year Post Vax 2
|
113 titer
Interval 82.5 to 155.2
|
256 titer
Interval 191.2 to 341.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, Pre Vax 2
|
186 titer
Interval 131.1 to 264.3
|
403 titer
Interval 290.6 to 558.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Year Post Vax 2
|
361 titer
Interval 263.4 to 495.7
|
511 titer
Interval 376.9 to 693.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, Pre Vax 2
|
66 titer
Interval 45.5 to 95.0
|
66 titer
Interval 46.3 to 95.3
|
—
|
SECONDARY outcome
Timeframe: Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=199 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=127 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=171 Participants
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Month Post Vax 1
|
727 titer
Interval 527.6 to 1000.7
|
614 titer
Interval 409.0 to 921.9
|
748 titer
Interval 535.4 to 1045.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Year Post Vax 2
|
435 titer
Interval 329.4 to 575.6
|
387 titer
Interval 277.1 to 540.7
|
391 titer
Interval 291.9 to 524.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Month Post Vax 1
|
1614 titer
Interval 1230.2 to 2117.7
|
1603 titer
Interval 1153.7 to 2226.2
|
888 titer
Interval 639.0 to 1233.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Year Post Vax 2
|
560 titer
Interval 424.2 to 739.8
|
409 titer
Interval 281.0 to 596.0
|
323 titer
Interval 227.9 to 457.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Month Post Vax 1
|
781 titer
Interval 662.0 to 920.4
|
698 titer
Interval 522.4 to 932.2
|
380 titer
Interval 296.6 to 486.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Month Post Vax 1
|
228 titer
Interval 185.8 to 280.7
|
229 titer
Interval 176.7 to 295.9
|
147 titer
Interval 112.6 to 192.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Year Post Vax 2
|
47 titer
Interval 37.5 to 60.0
|
54 titer
Interval 40.6 to 71.4
|
35 titer
Interval 26.6 to 46.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Month Post Vax 1
|
75 titer
Interval 61.6 to 91.6
|
75 titer
Interval 59.1 to 95.5
|
85 titer
Interval 69.0 to 103.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Year Post Vax 2
|
27 titer
Interval 22.5 to 32.8
|
19 titer
Interval 14.8 to 23.3
|
18 titer
Interval 14.8 to 22.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Month Post Vax 1
|
2575 titer
Interval 2075.2 to 3195.9
|
2546 titer
Interval 1908.6 to 3395.8
|
1406 titer
Interval 1026.6 to 1926.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Year Post Vax 2
|
405 titer
Interval 304.4 to 538.3
|
346 titer
Interval 242.6 to 493.7
|
184 titer
Interval 127.1 to 267.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Month Post Vax 1
|
255 titer
Interval 190.1 to 341.4
|
153 titer
Interval 101.6 to 229.5
|
145 titer
Interval 106.8 to 197.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Year Post Vax 2
|
69 titer
Interval 52.4 to 91.8
|
26 titer
Interval 18.5 to 37.8
|
45 titer
Interval 33.6 to 61.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Month Post Vax 1
|
3022 titer
Interval 2356.7 to 3875.6
|
2757 titer
Interval 2027.3 to 3750.3
|
335 titer
Interval 227.3 to 494.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Year Post Vax 2
|
235 titer
Interval 171.4 to 320.9
|
286 titer
Interval 195.1 to 418.1
|
105 titer
Interval 73.1 to 152.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Month Post Vax 1
|
1969 titer
Interval 1512.1 to 2562.7
|
1739 titer
Interval 1176.0 to 2570.2
|
767 titer
Interval 545.3 to 1080.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Year Post Vax 2
|
697 titer
Interval 523.9 to 926.4
|
855 titer
Interval 595.2 to 1227.5
|
319 titer
Interval 220.5 to 462.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Month Post Vax 1
|
1459 titer
Interval 1147.2 to 1855.1
|
906 titer
Interval 590.6 to 1388.7
|
365 titer
Interval 243.8 to 546.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Year Post Vax 2
|
398 titer
Interval 301.1 to 527.0
|
231 titer
Interval 148.8 to 359.6
|
143 titer
Interval 97.9 to 208.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Month Post Vax 1
|
801 titer
Interval 589.0 to 1090.0
|
1055 titer
Interval 740.6 to 1502.7
|
294 titer
Interval 192.2 to 449.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Year Post Vax 2
|
224 titer
Interval 155.1 to 322.3
|
203 titer
Interval 127.4 to 322.0
|
127 titer
Interval 82.5 to 196.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Year Post Vax 2
|
310 titer
Interval 260.8 to 369.0
|
243 titer
Interval 185.7 to 319.1
|
162 titer
Interval 126.7 to 207.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Month Post Vax 1
|
845 titer
Interval 661.8 to 1079.9
|
530 titer
Interval 361.7 to 775.7
|
423 titer
Interval 302.2 to 591.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Year Post Vax 2
|
416 titer
Interval 333.0 to 519.7
|
239 titer
Interval 166.7 to 342.6
|
180 titer
Interval 131.7 to 245.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Month Post Vax 1
|
367 titer
Interval 268.3 to 501.2
|
339 titer
Interval 219.9 to 521.8
|
72 titer
Interval 49.1 to 104.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Year Post Vax 2
|
70 titer
Interval 52.0 to 95.0
|
105 titer
Interval 69.5 to 159.3
|
39 titer
Interval 27.6 to 53.8
|
SECONDARY outcome
Timeframe: Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)Population: 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.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=218 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=214 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Year Post Vax 2
|
236 titer
Interval 175.5 to 318.0
|
205 titer
Interval 155.8 to 270.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Month Post Vax 1
|
42 titer
Interval 31.6 to 55.2
|
84 titer
Interval 64.7 to 108.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Month Post Vax 1
|
53 titer
Interval 41.5 to 68.2
|
92 titer
Interval 72.4 to 118.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Year Post Vax 2
|
22 titer
Interval 17.5 to 28.0
|
39 titer
Interval 31.5 to 48.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Month Post Vax 1
|
51 titer
Interval 41.5 to 63.5
|
52 titer
Interval 42.2 to 63.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Year Post Vax 2
|
16 titer
Interval 13.1 to 19.1
|
19 titer
Interval 16.2 to 23.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Month Post Vax 1
|
216 titer
Interval 151.2 to 308.2
|
511 titer
Interval 374.5 to 697.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Year Post Vax 2
|
185 titer
Interval 136.2 to 249.9
|
271 titer
Interval 203.9 to 361.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
42 titer
Interval 31.9 to 55.2
|
58 titer
Interval 45.6 to 75.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Month Post Vax 1
|
106 titer
Interval 75.2 to 149.1
|
975 titer
Interval 715.1 to 1328.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Year Post Vax 2
|
115 titer
Interval 84.3 to 158.2
|
264 titer
Interval 197.8 to 353.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Month Post Vax 1
|
465 titer
Interval 333.3 to 648.1
|
1331 titer
Interval 981.1 to 1806.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Year Post Vax 2
|
396 titer
Interval 289.7 to 540.2
|
553 titer
Interval 411.3 to 743.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Month Post Vax 1
|
195 titer
Interval 134.4 to 281.9
|
328 titer
Interval 233.5 to 459.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Year Post Vax 2
|
112 titer
Interval 79.2 to 159.1
|
165 titer
Interval 119.3 to 227.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Month Post Vax 1
|
102 titer
Interval 68.2 to 152.2
|
193 titer
Interval 131.4 to 282.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
69 titer
Interval 46.9 to 101.2
|
82 titer
Interval 55.3 to 121.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Month Post Vax 1
|
280 titer
Interval 203.3 to 384.3
|
241 titer
Interval 179.4 to 325.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Month Post Vax 1
|
555 titer
Interval 405.8 to 759.9
|
946 titer
Interval 749.2 to 1195.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Year Post Vax 2
|
370 titer
Interval 276.9 to 495.3
|
544 titer
Interval 435.5 to 679.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Month Post Vax 1
|
199 titer
Interval 157.3 to 251.4
|
381 titer
Interval 312.9 to 462.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Year Post Vax 2
|
180 titer
Interval 145.9 to 222.1
|
232 titer
Interval 192.7 to 279.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Month Post Vax 1
|
238 titer
Interval 177.4 to 320.2
|
407 titer
Interval 312.1 to 531.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Year Post Vax 2
|
158 titer
Interval 118.2 to 211.0
|
281 titer
Interval 219.7 to 358.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Month Post Vax 1
|
48 titer
Interval 35.2 to 65.6
|
173 titer
Interval 125.5 to 239.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Year Post Vax 2
|
45 titer
Interval 33.0 to 60.2
|
106 titer
Interval 79.7 to 141.5
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=209 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=127 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
n=173 Participants
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, Pre Vax 1
|
6 titer
Interval 5.4 to 7.1
|
7 titer
Interval 5.6 to 7.9
|
7 titer
Interval 6.2 to 8.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Year Post Vax 2
|
52 titer
Interval 40.9 to 65.5
|
54 titer
Interval 40.8 to 70.4
|
36 titer
Interval 27.0 to 46.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, Pre Vax 1
|
6 titer
Interval 5.3 to 7.0
|
6 titer
Interval 5.0 to 6.9
|
7 titer
Interval 5.6 to 7.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Year Post Vax 2
|
27 titer
Interval 22.1 to 32.3
|
19 titer
Interval 14.9 to 23.5
|
17 titer
Interval 14.0 to 21.3
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, Pre Vax 1
|
36 titer
Interval 23.8 to 54.0
|
24 titer
Interval 14.7 to 40.3
|
31 titer
Interval 20.3 to 47.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Year Post Vax 2
|
323 titer
Interval 233.9 to 445.7
|
314 titer
Interval 208.6 to 472.1
|
170 titer
Interval 115.4 to 249.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, Pre Vax 1
|
6 titer
Interval 5.2 to 6.9
|
5 titer
Interval 4.2 to 5.3
|
6 titer
Interval 4.9 to 6.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Year Post Vax 2
|
75 titer
Interval 57.4 to 99.2
|
29 titer
Interval 20.4 to 41.4
|
43 titer
Interval 31.4 to 57.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, Pre Vax 1
|
17 titer
Interval 12.4 to 24.6
|
21 titer
Interval 13.5 to 31.9
|
14 titer
Interval 10.1 to 20.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Year Post Vax 2
|
214 titer
Interval 153.1 to 298.7
|
313 titer
Interval 210.4 to 464.4
|
94 titer
Interval 64.0 to 137.6
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, Pre Vax 1
|
24 titer
Interval 16.7 to 35.7
|
35 titer
Interval 20.6 to 58.4
|
26 titer
Interval 17.3 to 40.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Year Post Vax 2
|
522 titer
Interval 378.0 to 719.8
|
720 titer
Interval 474.8 to 1090.7
|
292 titer
Interval 197.3 to 431.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, Pre Vax 1
|
8 titer
Interval 6.3 to 10.5
|
7 titer
Interval 5.4 to 10.0
|
7 titer
Interval 5.7 to 9.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Year Post Vax 2
|
384 titer
Interval 290.3 to 508.9
|
238 titer
Interval 152.5 to 370.7
|
143 titer
Interval 97.6 to 208.7
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, Pre Vax 1
|
15 titer
Interval 10.7 to 21.5
|
15 titer
Interval 9.5 to 22.5
|
18 titer
Interval 11.9 to 26.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Year Post Vax 2
|
192 titer
Interval 130.6 to 283.3
|
187 titer
Interval 116.1 to 301.9
|
119 titer
Interval 76.6 to 185.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, Pre Vax 1
|
34 titer
Interval 23.1 to 48.6
|
27 titer
Interval 17.6 to 42.5
|
46 titer
Interval 30.9 to 67.1
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Year Post Vax 2
|
385 titer
Interval 286.5 to 518.5
|
350 titer
Interval 249.6 to 489.5
|
366 titer
Interval 271.3 to 494.2
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, Pre Vax 1
|
25 titer
Interval 17.8 to 33.8
|
20 titer
Interval 13.5 to 29.7
|
33 titer
Interval 22.9 to 47.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Year Post Vax 2
|
546 titer
Interval 415.3 to 718.0
|
400 titer
Interval 274.2 to 584.1
|
324 titer
Interval 229.8 to 455.8
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, Pre Vax 1
|
25 titer
Interval 19.1 to 32.9
|
20 titer
Interval 14.6 to 28.6
|
21 titer
Interval 15.9 to 28.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Year Post Vax 2
|
327 titer
Interval 273.7 to 391.0
|
245 titer
Interval 188.5 to 319.5
|
162 titer
Interval 125.9 to 209.4
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, Pre Vax 1
|
24 titer
Interval 17.3 to 33.4
|
20 titer
Interval 13.1 to 29.0
|
16 titer
Interval 11.7 to 22.5
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Year Post Vax 2
|
415 titer
Interval 332.9 to 516.2
|
237 titer
Interval 165.0 to 340.7
|
186 titer
Interval 136.5 to 253.0
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, Pre Vax 1
|
9 titer
Interval 7.1 to 11.2
|
10 titer
Interval 7.0 to 13.0
|
7 titer
Interval 5.8 to 8.9
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Year Post Vax 2
|
59 titer
Interval 43.9 to 80.6
|
114 titer
Interval 75.4 to 172.9
|
34 titer
Interval 24.2 to 47.1
|
SECONDARY outcome
Timeframe: Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=218 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=218 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F 1 Year Post Vax 2
|
45 titer
Interval 33.7 to 61.1
|
99 titer
Interval 74.0 to 131.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, Pre Vax 1
|
10 titer
Interval 7.9 to 11.5
|
10 titer
Interval 8.7 to 12.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Year Post Vax 2
|
22 titer
Interval 17.6 to 28.1
|
38 titer
Interval 30.9 to 47.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, Pre Vax 1
|
10 titer
Interval 8.6 to 12.2
|
9 titer
Interval 7.7 to 11.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Year Post Vax 2
|
16 titer
Interval 12.9 to 18.7
|
20 titer
Interval 16.4 to 23.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, Pre Vax 1
|
27 titer
Interval 19.0 to 38.7
|
30 titer
Interval 20.4 to 42.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Year Post Vax 2
|
160 titer
Interval 117.1 to 219.2
|
238 titer
Interval 176.8 to 319.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, Pre Vax 1
|
14 titer
Interval 10.8 to 17.6
|
12 titer
Interval 9.3 to 14.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
43 titer
Interval 32.7 to 56.7
|
57 titer
Interval 44.4 to 73.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, Pre Vax 1
|
31 titer
Interval 22.1 to 42.6
|
22 titer
Interval 16.0 to 29.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Year Post Vax 2
|
108 titer
Interval 78.4 to 148.3
|
259 titer
Interval 192.7 to 346.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, Pre Vax 1
|
123 titer
Interval 84.0 to 179.4
|
79 titer
Interval 54.1 to 113.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Year Post Vax 2
|
385 titer
Interval 278.9 to 531.9
|
507 titer
Interval 368.6 to 696.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, Pre Vax 1
|
21 titer
Interval 14.7 to 28.9
|
23 titer
Interval 16.4 to 32.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Year Post Vax 2
|
115 titer
Interval 81.7 to 163.2
|
169 titer
Interval 122.3 to 232.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, Pre Vax 1
|
23 titer
Interval 15.9 to 32.6
|
21 titer
Interval 14.4 to 29.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
66 titer
Interval 45.3 to 97.4
|
75 titer
Interval 50.5 to 111.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, Pre Vax 1
|
79 titer
Interval 55.5 to 111.2
|
70 titer
Interval 49.9 to 97.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Year Post Vax 2
|
224 titer
Interval 167.0 to 299.6
|
202 titer
Interval 153.2 to 266.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, Pre Vax 1
|
145 titer
Interval 103.9 to 201.9
|
131 titer
Interval 95.8 to 178.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Year Post Vax 2
|
368 titer
Interval 277.8 to 488.9
|
530 titer
Interval 425.0 to 660.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, Pre Vax 1
|
66 titer
Interval 50.9 to 85.3
|
79 titer
Interval 62.4 to 101.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Year Post Vax 2
|
175 titer
Interval 141.8 to 216.8
|
236 titer
Interval 197.3 to 283.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, Pre Vax 1
|
37 titer
Interval 27.6 to 50.9
|
46 titer
Interval 33.2 to 62.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Year Post Vax 2
|
151 titer
Interval 112.6 to 201.6
|
272 titer
Interval 212.8 to 346.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, Pre Vax 1
|
16 titer
Interval 12.5 to 21.6
|
14 titer
Interval 11.1 to 18.4
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=179 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=209 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 1
|
36 titer
Interval 27.1 to 46.7
|
52 titer
Interval 40.9 to 65.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 3
|
18 titer
Interval 14.4 to 21.9
|
27 titer
Interval 22.2 to 32.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 4
|
183 titer
Interval 127.7 to 263.2
|
355 titer
Interval 264.7 to 475.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 5
|
44 titer
Interval 32.9 to 59.6
|
76 titer
Interval 58.0 to 99.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 6A
|
102 titer
Interval 71.4 to 146.9
|
225 titer
Interval 163.6 to 308.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 6B
|
324 titer
Interval 225.0 to 466.1
|
593 titer
Interval 441.4 to 797.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 7F
|
145 titer
Interval 100.3 to 210.7
|
412 titer
Interval 313.1 to 541.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 9V
|
129 titer
Interval 84.5 to 196.5
|
221 titer
Interval 154.2 to 316.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 14
|
383 titer
Interval 286.9 to 510.6
|
416 titer
Interval 316.2 to 548.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 18C
|
337 titer
Interval 240.7 to 471.7
|
527 titer
Interval 401.7 to 690.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 19A
|
170 titer
Interval 134.4 to 214.8
|
313 titer
Interval 263.1 to 372.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 19F
|
195 titer
Interval 145.1 to 262.1
|
426 titer
Interval 343.7 to 527.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)
Serotype 23F
|
35 titer
Interval 25.6 to 48.6
|
64 titer
Interval 47.6 to 86.5
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=179 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=129 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 1
|
36 titer
Interval 27.1 to 46.7
|
54 titer
Interval 40.8 to 71.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 3
|
18 titer
Interval 14.4 to 21.9
|
19 titer
Interval 15.0 to 23.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 4
|
183 titer
Interval 127.7 to 263.2
|
328 titer
Interval 229.0 to 469.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 5
|
44 titer
Interval 32.9 to 59.6
|
29 titer
Interval 20.4 to 41.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A
|
102 titer
Interval 71.4 to 146.9
|
316 titer
Interval 216.5 to 461.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B
|
324 titer
Interval 225.0 to 466.1
|
785 titer
Interval 540.6 to 1140.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
145 titer
Interval 100.3 to 210.7
|
247 titer
Interval 160.4 to 380.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V
|
129 titer
Interval 84.5 to 196.5
|
211 titer
Interval 134.3 to 330.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
383 titer
Interval 286.9 to 510.6
|
379 titer
Interval 273.6 to 526.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
337 titer
Interval 240.7 to 471.7
|
393 titer
Interval 271.3 to 569.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
170 titer
Interval 134.4 to 214.8
|
244 titer
Interval 189.1 to 314.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F
|
195 titer
Interval 145.1 to 262.1
|
256 titer
Interval 182.4 to 359.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F
|
35 titer
Interval 25.6 to 48.6
|
110 titer
Interval 73.9 to 165.0
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=209 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=129 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 1
|
52 titer
Interval 40.9 to 65.5
|
54 titer
Interval 40.8 to 71.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 3
|
27 titer
Interval 22.2 to 32.3
|
19 titer
Interval 15.0 to 23.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 4
|
355 titer
Interval 264.7 to 475.9
|
328 titer
Interval 229.0 to 469.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 5
|
76 titer
Interval 58.0 to 99.7
|
29 titer
Interval 20.4 to 41.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A
|
225 titer
Interval 163.6 to 308.3
|
316 titer
Interval 216.5 to 461.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B
|
593 titer
Interval 441.4 to 797.3
|
785 titer
Interval 540.6 to 1140.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
412 titer
Interval 313.1 to 541.2
|
247 titer
Interval 160.4 to 380.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V
|
221 titer
Interval 154.2 to 316.0
|
211 titer
Interval 134.3 to 330.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
416 titer
Interval 316.2 to 548.2
|
379 titer
Interval 273.6 to 526.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
527 titer
Interval 401.7 to 690.5
|
393 titer
Interval 271.3 to 569.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
313 titer
Interval 263.1 to 372.3
|
244 titer
Interval 189.1 to 314.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F
|
426 titer
Interval 343.7 to 527.7
|
256 titer
Interval 182.4 to 359.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F
|
64 titer
Interval 47.6 to 86.5
|
110 titer
Interval 73.9 to 165.0
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=222 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=220 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 1
|
22 titer
Interval 17.5 to 27.8
|
38 titer
Interval 30.9 to 47.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 3
|
16 titer
Interval 13.3 to 19.2
|
20 titer
Interval 16.5 to 23.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 4
|
172 titer
Interval 129.0 to 230.1
|
265 titer
Interval 200.8 to 348.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 5
|
42 titer
Interval 32.2 to 55.6
|
58 titer
Interval 45.1 to 74.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A
|
115 titer
Interval 84.5 to 156.8
|
250 titer
Interval 187.3 to 334.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B
|
381 titer
Interval 281.9 to 513.9
|
510 titer
Interval 378.2 to 686.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F
|
115 titer
Interval 81.6 to 160.9
|
173 titer
Interval 126.0 to 237.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V
|
68 titer
Interval 47.4 to 98.5
|
81 titer
Interval 55.1 to 117.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 14
|
240 titer
Interval 181.0 to 317.0
|
202 titer
Interval 154.6 to 265.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C
|
360 titer
Interval 273.6 to 474.5
|
540 titer
Interval 435.5 to 668.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A
|
181 titer
Interval 146.7 to 222.9
|
232 titer
Interval 193.2 to 278.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F
|
158 titer
Interval 119.3 to 209.9
|
277 titer
Interval 218.6 to 351.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F
|
45 titer
Interval 33.5 to 69.6
|
103 titer
Interval 78.0 to 135.0
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=175 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=209 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1
|
45 titer
Interval 34.5 to 59.8
|
52 titer
Interval 40.9 to 65.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3
|
26 titer
Interval 20.4 to 32.5
|
27 titer
Interval 22.2 to 32.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4
|
332 titer
Interval 231.8 to 476.2
|
355 titer
Interval 264.7 to 475.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5
|
49 titer
Interval 36.4 to 66.9
|
76 titer
Interval 58.0 to 99.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A
|
82 titer
Interval 54.6 to 122.4
|
225 titer
Interval 163.6 to 308.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B
|
162 titer
Interval 108.9 to 241.6
|
593 titer
Interval 441.4 to 797.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
66 titer
Interval 44.1 to 100.1
|
412 titer
Interval 313.1 to 541.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V
|
52 titer
Interval 33.7 to 80.3
|
221 titer
Interval 154.2 to 316.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
302 titer
Interval 214.2 to 425.3
|
416 titer
Interval 316.2 to 548.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
319 titer
Interval 222.5 to 457.3
|
527 titer
Interval 401.7 to 690.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
153 titer
Interval 117.3 to 199.5
|
313 titer
Interval 263.1 to 372.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F
|
125 titer
Interval 88.8 to 176.5
|
426 titer
Interval 343.7 to 527.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F
|
30 titer
Interval 21.2 to 42.1
|
64 titer
Interval 47.6 to 86.5
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=332 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=179 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1
|
54 titer
Interval 45.4 to 65.0
|
36 titer
Interval 27.1 to 46.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3
|
21 titer
Interval 18.1 to 24.9
|
18 titer
Interval 14.4 to 21.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4
|
622 titer
Interval 496.9 to 777.7
|
183 titer
Interval 127.7 to 263.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5
|
52 titer
Interval 40.9 to 64.8
|
44 titer
Interval 32.9 to 59.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A
|
597 titer
Interval 466.8 to 764.7
|
102 titer
Interval 71.4 to 146.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B
|
420 titer
Interval 320.2 to 552.0
|
324 titer
Interval 225.0 to 466.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
133 titer
Interval 99.6 to 177.8
|
145 titer
Interval 100.3 to 210.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V
|
85 titer
Interval 62.7 to 115.4
|
129 titer
Interval 84.5 to 196.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
250 titer
Interval 193.5 to 324.2
|
383 titer
Interval 286.9 to 510.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
439 titer
Interval 349.8 to 551.0
|
337 titer
Interval 240.7 to 471.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
208 titer
Interval 175.9 to 245.7
|
170 titer
Interval 134.4 to 214.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F
|
147 titer
Interval 115.1 to 187.7
|
195 titer
Interval 145.1 to 262.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F
|
90 titer
Interval 69.9 to 116.6
|
35 titer
Interval 25.6 to 48.6
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=124 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, 1 Year Post Vax 2
|
—
|
201 titer
Interval 125.8 to 320.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, Pre Vax 2
|
—
|
241 titer
Interval 159.6 to 364.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14, 1 Year Post Vax 2
|
—
|
383 titer
Interval 274.1 to 534.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, Pre Vax 2
|
—
|
403 titer
Interval 273.8 to 592.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C, 1 Year Post Vax 2
|
—
|
398 titer
Interval 274.1 to 579.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, Pre Vax 2
|
—
|
203 titer
Interval 151.3 to 271.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A, 1 Year Post Vax 2
|
—
|
253 titer
Interval 197.2 to 325.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, Pre Vax 2
|
—
|
114 titer
Interval 72.7 to 177.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F, 1 Year Post Vax 2
|
—
|
238 titer
Interval 165.2 to 341.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, Pre Vax 2
|
—
|
90 titer
Interval 58.5 to 139.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F, 1 Year Post Vax 2
|
—
|
104 titer
Interval 67.9 to 158.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, Pre Vax 2
|
—
|
52 titer
Interval 38.2 to 69.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1, 1 Year Post Vax 2
|
—
|
52 titer
Interval 39.6 to 69.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, Pre Vax 2
|
—
|
19 titer
Interval 14.5 to 24.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3, 1 Year Post Vax 2
|
—
|
18 titer
Interval 14.2 to 22.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, Pre Vax 2
|
—
|
710 titer
Interval 504.4 to 998.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4, 1 Year Post Vax 2
|
—
|
376 titer
Interval 264.2 to 534.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, Pre Vax 2
|
—
|
39 titer
Interval 26.2 to 56.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5, 1 Year Post Vax 2
|
—
|
29 titer
Interval 20.4 to 42.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, Pre Vax 2
|
—
|
540 titer
Interval 347.1 to 838.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A, 1 Year Post Vax 2
|
—
|
331 titer
Interval 227.1 to 483.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, Pre Vax 2
|
—
|
459 titer
Interval 292.2 to 719.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B, 1 Year Post Vax 2
|
—
|
781 titer
Interval 529.8 to 1150.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, Pre Vax 2
|
—
|
146 titer
Interval 89.4 to 237.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F, 1 Year Post Vax 2
|
—
|
244 titer
Interval 155.7 to 383.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V, Pre Vax 2
|
—
|
96 titer
Interval 58.3 to 158.4
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=220 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=222 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1
|
33 titer
Interval 26.6 to 41.3
|
22 titer
Interval 17.5 to 27.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3
|
16 titer
Interval 13.5 to 19.6
|
16 titer
Interval 13.3 to 19.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4
|
123 titer
Interval 85.4 to 177.6
|
172 titer
Interval 129.0 to 230.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5
|
31 titer
Interval 24.4 to 40.2
|
42 titer
Interval 32.2 to 55.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A
|
271 titer
Interval 197.5 to 370.6
|
115 titer
Interval 84.5 to 156.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B
|
380 titer
Interval 274.0 to 526.3
|
381 titer
Interval 281.9 to 513.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F
|
61 titer
Interval 43.0 to 87.7
|
115 titer
Interval 81.6 to 160.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V
|
40 titer
Interval 27.8 to 58.3
|
68 titer
Interval 47.4 to 98.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14
|
126 titer
Interval 93.0 to 170.7
|
240 titer
Interval 181.0 to 317.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C
|
439 titer
Interval 343.4 to 559.9
|
360 titer
Interval 273.6 to 474.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A
|
183 titer
Interval 151.3 to 220.7
|
181 titer
Interval 146.7 to 222.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F
|
115 titer
Interval 87.4 to 151.3
|
158 titer
Interval 119.3 to 209.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F
|
59 titer
Interval 43.7 to 79.4
|
45 titer
Interval 33.5 to 59.6
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=217 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, Pre Vax 2
|
—
|
33 titer
Interval 26.4 to 41.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1, 1 Year Post Vax 2
|
—
|
38 titer
Interval 30.7 to 47.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, Pre Vax 2
|
—
|
16 titer
Interval 13.2 to 19.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3, 1 Year Post Vax 2
|
—
|
19 titer
Interval 16.2 to 23.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, Pre Vax 2
|
—
|
129 titer
Interval 89.0 to 186.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4, 1 Year Post Vax 2
|
—
|
267 titer
Interval 198.8 to 358.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, Pre Vax 2
|
—
|
32 titer
Interval 25.0 to 41.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
—
|
57 titer
Interval 44.5 to 73.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, Pre Vax 2
|
—
|
279 titer
Interval 203.4 to 383.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, 1 Year Post Vax 2
|
—
|
256 titer
Interval 191.2 to 341.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, Pre Vax 2
|
—
|
403 titer
Interval 290.6 to 558.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B, 1 Year Post Vax 2
|
—
|
511 titer
Interval 376.9 to 693.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, Pre Vax 2
|
—
|
66 titer
Interval 46.3 to 95.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F, 1 Year Post Vax 2
|
—
|
175 titer
Interval 127.1 to 240.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, Pre Vax 2
|
—
|
40 titer
Interval 27.6 to 59.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
—
|
76 titer
Interval 51.6 to 112.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, Pre Vax 2
|
—
|
130 titer
Interval 96.1 to 176.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14, 1 Year Post Vax 2
|
—
|
204 titer
Interval 155.6 to 268.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, Pre Vax 2
|
—
|
436 titer
Interval 340.9 to 556.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C, 1 Year Post Vax 2
|
—
|
545 titer
Interval 438.2 to 678.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, Pre Vax 2
|
—
|
185 titer
Interval 152.8 to 222.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A, 1 Year Post Vax 2
|
—
|
235 titer
Interval 196.4 to 282.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, Pre Vax 2
|
—
|
121 titer
Interval 91.1 to 160.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F, 1 Year Post Vax 2
|
—
|
261 titer
Interval 204.9 to 333.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, Pre Vax 2
|
—
|
60 titer
Interval 44.5 to 81.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F, 1 Year Post Vax 2
|
—
|
104 titer
Interval 78.0 to 137.4
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00574548)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=175 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=332 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 1
|
45 titer
Interval 34.5 to 59.8
|
54 titer
Interval 45.4 to 65.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 3
|
26 titer
Interval 20.4 to 32.5
|
21 titer
Interval 18.1 to 24.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 4
|
332 titer
Interval 231.8 to 476.2
|
622 titer
Interval 496.9 to 777.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 5
|
49 titer
Interval 36.4 to 66.9
|
52 titer
Interval 40.9 to 64.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6A
|
82 titer
Interval 54.6 to 122.4
|
597 titer
Interval 466.8 to 764.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 6B
|
162 titer
Interval 108.9 to 241.6
|
420 titer
Interval 320.2 to 552.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
66 titer
Interval 44.1 to 100.1
|
133 titer
Interval 99.6 to 177.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 9V
|
52 titer
Interval 33.7 to 80.3
|
85 titer
Interval 62.7 to 115.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
302 titer
Interval 214.2 to 425.3
|
250 titer
Interval 193.5 to 324.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
319 titer
Interval 222.5 to 457.3
|
439 titer
Interval 349.8 to 551.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
153 titer
Interval 117.3 to 199.5
|
208 titer
Interval 175.9 to 245.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19F
|
125 titer
Interval 88.8 to 176.5
|
147 titer
Interval 115.1 to 187.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 23F
|
30 titer
Interval 21.2 to 42.1
|
90 titer
Interval 69.9 to 116.6
|
—
|
SECONDARY outcome
Timeframe: Month 0/Year 1 (Parent Study NCT00546572)Population: All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.
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.
Outcome measures
| Measure |
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
n=222 Participants
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)
|
13vPnC/13vPnC Group (23vPS Naïve)
n=220 Participants
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)
|
23vPS/13vPnC Group (23vPS Naïve)
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)
|
|---|---|---|---|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 1
|
21 titer
Interval 16.8 to 26.5
|
33 titer
Interval 26.6 to 41.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 3
|
16 titer
Interval 13.2 to 19.8
|
16 titer
Interval 13.5 to 19.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4
|
68 titer
Interval 47.0 to 96.9
|
123 titer
Interval 85.4 to 177.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5
|
23 titer
Interval 17.6 to 29.7
|
31 titer
Interval 24.4 to 40.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A
|
57 titer
Interval 40.9 to 78.2
|
271 titer
Interval 197.5 to 370.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6B
|
168 titer
Interval 118.6 to 238.1
|
380 titer
Interval 274.0 to 526.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 7F
|
63 titer
Interval 43.8 to 91.1
|
61 titer
Interval 43.0 to 87.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V
|
29 titer
Interval 20.3 to 41.3
|
40 titer
Interval 27.8 to 58.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 14
|
140 titer
Interval 101.7 to 192.7
|
126 titer
Interval 93.0 to 170.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19A
|
122 titer
Interval 96.0 to 155.9
|
183 titer
Interval 151.3 to 220.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F
|
86 titer
Interval 63.2 to 115.9
|
115 titer
Interval 87.4 to 151.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F
|
30 titer
Interval 22.3 to 41.0
|
59 titer
Interval 43.7 to 79.4
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 18C
|
271 titer
Interval 197.8 to 371.7
|
439 titer
Interval 343.4 to 559.9
|
—
|
Adverse Events
13vPnC/13vPnC Group (23vPS Naïve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC/23vPS Group (23vPS Naïve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
23vPS/13vPnC Group (23vPS Naïve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER