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=99 Participants
|
64.1 Years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
64.2 Years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
78.3 Years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
77.8 Years
STANDARD_DEVIATION 4.1 • n=31 Participants
|
70.5 Years
STANDARD_DEVIATION 7.6 • n=30 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
115 Participants
n=31 Participants
|
532 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
107 Participants
n=31 Participants
|
430 Participants
n=30 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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=129 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 3
|
19 titer
Interval 15.0 to 23.5
|
27 titer
Interval 22.2 to 32.3
|
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
|
328 titer
Interval 229.0 to 469.0
|
355 titer
Interval 264.7 to 475.9
|
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 7F
|
247 titer
Interval 160.4 to 380.9
|
412 titer
Interval 313.1 to 541.2
|
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 1
|
54 titer
Interval 40.8 to 71.0
|
52 titer
Interval 40.9 to 65.5
|
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 6A
|
316 titer
Interval 216.5 to 461.2
|
225 titer
Interval 163.6 to 308.3
|
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 5
|
29 titer
Interval 20.4 to 41.4
|
76 titer
Interval 58.0 to 99.7
|
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 6B
|
785 titer
Interval 540.6 to 1140.2
|
593 titer
Interval 441.4 to 797.3
|
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 9V
|
211 titer
Interval 134.3 to 330.9
|
221 titer
Interval 154.2 to 316.0
|
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
|
379 titer
Interval 273.6 to 526.2
|
416 titer
Interval 316.2 to 548.2
|
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 18C
|
393 titer
Interval 271.3 to 569.3
|
527 titer
Interval 401.7 to 690.5
|
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 19A
|
244 titer
Interval 189.1 to 314.1
|
313 titer
Interval 263.1 to 372.3
|
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 19F
|
256 titer
Interval 182.4 to 359.0
|
426 titer
Interval 343.7 to 527.7
|
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
|
110 titer
Interval 73.9 to 165.0
|
64 titer
Interval 47.6 to 86.5
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=220 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
38 titer
Interval 30.9 to 47.9
|
22 titer
Interval 17.5 to 27.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 3
|
20 titer
Interval 16.5 to 23.4
|
16 titer
Interval 13.3 to 19.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 4
|
265 titer
Interval 200.8 to 348.5
|
172 titer
Interval 129.0 to 230.1
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 5
|
58 titer
Interval 45.1 to 74.1
|
42 titer
Interval 32.2 to 55.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 6A
|
250 titer
Interval 187.3 to 334.0
|
115 titer
Interval 84.5 to 156.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 6B
|
510 titer
Interval 378.2 to 686.4
|
381 titer
Interval 281.9 to 513.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 7F
|
173 titer
Interval 126.0 to 237.5
|
115 titer
Interval 81.6 to 160.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 9V
|
81 titer
Interval 55.1 to 117.9
|
68 titer
Interval 47.4 to 98.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 14
|
202 titer
Interval 154.6 to 265.0
|
240 titer
Interval 181.0 to 317.0
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 18C
|
540 titer
Interval 435.5 to 668.5
|
360 titer
Interval 273.6 to 474.5
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 19A
|
232 titer
Interval 193.2 to 278.1
|
181 titer
Interval 146.7 to 222.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 19F
|
277 titer
Interval 218.6 to 351.7
|
158 titer
Interval 119.3 to 209.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Serotype 23F
|
103 titer
Interval 78.0 to 135.5
|
45 titer
Interval 33.5 to 59.6
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=126 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=204 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 3, 1 Month Post Vax 2
|
87 titer
Interval 73.7 to 103.8
|
130 titer
Interval 112.8 to 150.3
|
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
|
18 titer
Interval 14.6 to 22.9
|
27 titer
Interval 22.2 to 32.5
|
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 7F, 1 Month Post Vax 2
|
306 titer
Interval 201.8 to 462.5
|
667 titer
Interval 531.5 to 836.8
|
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 14, 1 Month Post Vax 2
|
434 titer
Interval 311.6 to 605.6
|
639 titer
Interval 487.8 to 836.3
|
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 18C, 1 Month Post Vax 2
|
972 titer
Interval 732.4 to 1290.1
|
1092 titer
Interval 879.6 to 1356.2
|
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 23F, 1 Month Post Vax 2
|
543 titer
Interval 392.9 to 749.4
|
218 titer
Interval 164.8 to 288.0
|
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
|
108 titer
Interval 71.9 to 162.3
|
63 titer
Interval 46.4 to 84.5
|
38 titer
Interval 27.1 to 52.2
|
|
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
|
141 titer
Interval 110.4 to 179.7
|
149 titer
Interval 123.5 to 180.6
|
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
|
54 titer
Interval 40.7 to 70.4
|
52 titer
Interval 41.1 to 66.1
|
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 4, 1 Month Post Vax 2
|
1284 titer
Interval 992.3 to 1661.9
|
1375 titer
Interval 1137.0 to 1663.8
|
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
|
318 titer
Interval 220.9 to 458.7
|
369 titer
Interval 276.1 to 493.9
|
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
|
95 titer
Interval 67.1 to 133.2
|
223 titer
Interval 180.7 to 276.3
|
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
|
29 titer
Interval 20.3 to 42.5
|
72 titer
Interval 54.6 to 95.1
|
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
|
2120 titer
Interval 1614.1 to 2783.9
|
1307 titer
Interval 1021.4 to 1672.8
|
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
|
304 titer
Interval 207.7 to 446.3
|
266 titer
Interval 195.2 to 362.6
|
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
|
1683 titer
Interval 1253.6 to 2258.3
|
1232 titer
Interval 965.9 to 1570.4
|
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
|
847 titer
Interval 590.8 to 1214.8
|
637 titer
Interval 476.3 to 851.6
|
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 Year Post Vax 2
|
237 titer
Interval 152.2 to 369.9
|
412 titer
Interval 313.2 to 541.5
|
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
|
385 titer
Interval 252.6 to 586.8
|
419 titer
Interval 298.6 to 588.0
|
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
|
221 titer
Interval 139.8 to 350.8
|
224 titer
Interval 155.9 to 321.6
|
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 Year Post Vax 2
|
380 titer
Interval 273.4 to 528.8
|
406 titer
Interval 306.7 to 537.0
|
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 Year Post Vax 2
|
373 titer
Interval 255.6 to 544.2
|
513 titer
Interval 389.6 to 676.7
|
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
|
365 titer
Interval 295.0 to 450.7
|
513 titer
Interval 445.6 to 590.5
|
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
|
213 titer
Interval 163.6 to 276.3
|
295 titer
Interval 246.6 to 352.7
|
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
|
493 titer
Interval 365.0 to 664.7
|
835 titer
Interval 685.5 to 1015.9
|
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
|
255 titer
Interval 180.5 to 360.8
|
425 titer
Interval 340.9 to 529.2
|
197 titer
Interval 146.4 to 266.2
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=216 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 6B, 1 Month Post Vax 2
|
1516 titer
Interval 1173.7 to 1957.5
|
781 titer
Interval 574.8 to 1061.9
|
—
|
|
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 Year Post Vax 2
|
561 titer
Interval 421.4 to 746.9
|
381 titer
Interval 282.6 to 514.5
|
—
|
|
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 14, 1 Month Post Vax 2
|
216 titer
Interval 163.8 to 284.3
|
199 titer
Interval 146.9 to 270.8
|
—
|
|
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 19A, 1 Month Post Vax 2
|
356 titer
Interval 297.6 to 425.6
|
255 titer
Interval 207.8 to 313.7
|
—
|
|
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 19F, 1 Year Post Vax 2
|
274 titer
Interval 214.2 to 350.8
|
158 titer
Interval 119.1 to 210.6
|
—
|
|
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 1, 1 Year Post Vax 2
|
39 titer
Interval 31.1 to 48.2
|
22 titer
Interval 17.4 to 27.6
|
—
|
|
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 3, 1 Month Post Vax 2
|
50 titer
Interval 42.1 to 59.2
|
32 titer
Interval 26.1 to 38.9
|
—
|
|
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 3, 1 Year Post Vax 2
|
20 titer
Interval 16.5 to 23.6
|
16 titer
Interval 13.2 to 19.1
|
—
|
|
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 4, 1 Month Post Vax 2
|
437 titer
Interval 332.0 to 576.3
|
237 titer
Interval 173.5 to 325.1
|
—
|
|
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 4, 1 Year Post Vax 2
|
311 titer
Interval 238.1 to 407.1
|
186 titer
Interval 138.3 to 250.2
|
—
|
|
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 5, 1 Month Post Vax 2
|
62 titer
Interval 48.1 to 79.4
|
49 titer
Interval 37.4 to 63.7
|
—
|
|
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 5, 1 Year Post Vax 2
|
58 titer
Interval 45.0 to 74.4
|
42 titer
Interval 31.7 to 54.8
|
—
|
|
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 6A, 1 Month Post Vax 2
|
1088 titer
Interval 843.2 to 1404.7
|
569 titer
Interval 421.8 to 768.5
|
—
|
|
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 6A, 1 Year Post Vax 2
|
257 titer
Interval 192.4 to 342.9
|
133 titer
Interval 97.4 to 182.1
|
—
|
|
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 7F, 1 Month Post Vax 2
|
233 titer
Interval 166.5 to 324.8
|
135 titer
Interval 93.2 to 194.5
|
—
|
|
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 7F, 1 Year Post Vax 2
|
173 titer
Interval 125.9 to 239.1
|
117 titer
Interval 82.8 to 165.4
|
—
|
|
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 9V, 1 Month Post Vax 2
|
166 titer
Interval 113.8 to 241.5
|
91 titer
Interval 62.0 to 133.3
|
—
|
|
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 9V, 1 Year Post Vax 2
|
83 titer
Interval 56.2 to 121.9
|
73 titer
Interval 49.9 to 105.9
|
—
|
|
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 Year Post Vax 2
|
209 titer
Interval 159.5 to 272.9
|
244 titer
Interval 184.5 to 321.9
|
—
|
|
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
|
1015 titer
Interval 832.6 to 1237.6
|
523 titer
Interval 395.1 to 693.5
|
—
|
|
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 18C, 1 Year Post Vax 2
|
553 titer
Interval 446.5 to 685.6
|
366 titer
Interval 277.2 to 482.9
|
—
|
|
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 19A, 1 Year Post Vax 2
|
228 titer
Interval 189.1 to 276.1
|
182 titer
Interval 147.7 to 225.2
|
—
|
|
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 19F, 1 Month Post Vax 2
|
349 titer
Interval 274.7 to 444.5
|
178 titer
Interval 134.1 to 235.0
|
—
|
|
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
|
324 titer
Interval 250.8 to 419.8
|
113 titer
Interval 82.4 to 154.8
|
—
|
|
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
|
102 titer
Interval 77.0 to 135.0
|
46 titer
Interval 33.9 to 61.7
|
—
|
|
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 Month Post Vax 2
|
80 titer
Interval 65.0 to 97.7
|
34 titer
Interval 27.2 to 43.7
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=124 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=204 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 3, Pre Vax 2
|
19 titer
Interval 14.5 to 24.1
|
23 titer
Interval 18.6 to 28.1
|
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 4, Pre Vax 2
|
710 titer
Interval 504.4 to 998.7
|
591 titer
Interval 437.9 to 798.0
|
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
|
376 titer
Interval 264.2 to 534.0
|
414 titer
Interval 312.3 to 548.2
|
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
|
39 titer
Interval 26.2 to 56.7
|
66 titer
Interval 48.9 to 87.8
|
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 6A, Pre Vax 2
|
540 titer
Interval 347.1 to 838.8
|
656 titer
Interval 484.0 to 888.4
|
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 7F, 1 Year Post Vax 2
|
244 titer
Interval 155.7 to 383.4
|
414 titer
Interval 313.8 to 546.5
|
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 19F, Pre Vax 2
|
114 titer
Interval 72.7 to 177.5
|
183 titer
Interval 135.0 to 247.7
|
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 1, Pre Vax 2
|
52 titer
Interval 38.2 to 69.5
|
56 titer
Interval 44.4 to 70.6
|
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
|
52 titer
Interval 39.6 to 69.0
|
50 titer
Interval 39.7 to 63.9
|
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, 1 Year Post Vax 2
|
18 titer
Interval 14.2 to 22.3
|
26 titer
Interval 21.4 to 31.6
|
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 5, 1 Year Post Vax 2
|
29 titer
Interval 20.4 to 42.1
|
73 titer
Interval 55.3 to 96.4
|
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, 1 Year Post Vax 2
|
331 titer
Interval 227.1 to 483.3
|
251 titer
Interval 183.4 to 343.3
|
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
|
459 titer
Interval 292.2 to 719.9
|
430 titer
Interval 304.8 to 605.6
|
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
|
781 titer
Interval 529.8 to 1150.8
|
580 titer
Interval 427.9 to 786.8
|
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
|
146 titer
Interval 89.4 to 237.1
|
133 titer
Interval 92.4 to 191.0
|
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 9V, Pre Vax 2
|
96 titer
Interval 58.3 to 158.4
|
79 titer
Interval 53.2 to 116.2
|
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
|
201 titer
Interval 125.8 to 320.2
|
212 titer
Interval 147.4 to 306.4
|
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 14, Pre Vax 2
|
241 titer
Interval 159.6 to 364.0
|
290 titer
Interval 208.6 to 403.1
|
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 14, 1 Year Post Vax 2
|
383 titer
Interval 274.1 to 534.2
|
420 titer
Interval 317.0 to 556.1
|
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
|
403 titer
Interval 273.8 to 592.0
|
462 titer
Interval 346.1 to 615.8
|
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 18C, 1 Year Post Vax 2
|
398 titer
Interval 274.1 to 579.1
|
513 titer
Interval 389.5 to 676.1
|
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
|
203 titer
Interval 151.3 to 271.8
|
209 titer
Interval 170.3 to 257.6
|
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
|
253 titer
Interval 197.2 to 325.7
|
296 titer
Interval 248.3 to 353.0
|
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, 1 Year Post Vax 2
|
238 titer
Interval 165.2 to 341.7
|
419 titer
Interval 334.2 to 524.2
|
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 58.5 to 139.9
|
90 titer
Interval 65.4 to 123.6
|
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
|
104 titer
Interval 67.9 to 158.6
|
66 titer
Interval 48.7 to 88.9
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=217 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=219 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 1, Pre Vax 2
|
33 titer
Interval 26.4 to 41.1
|
21 titer
Interval 17.1 to 26.9
|
—
|
|
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
|
175 titer
Interval 127.1 to 240.3
|
111 titer
Interval 78.4 to 157.4
|
—
|
|
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
|
40 titer
Interval 27.6 to 59.1
|
28 titer
Interval 19.7 to 40.6
|
—
|
|
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
|
545 titer
Interval 438.2 to 678.0
|
360 titer
Interval 272.5 to 475.9
|
—
|
|
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
|
38 titer
Interval 30.7 to 47.5
|
22 titer
Interval 17.5 to 27.8
|
—
|
|
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 13.2 to 19.4
|
16 titer
Interval 13.0 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
|
19 titer
Interval 16.2 to 23.2
|
16 titer
Interval 13.3 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 4, Pre Vax 2
|
129 titer
Interval 89.0 to 186.9
|
73 titer
Interval 50.4 to 104.7
|
—
|
|
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
|
267 titer
Interval 198.8 to 358.8
|
177 titer
Interval 129.9 to 240.0
|
—
|
|
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
|
32 titer
Interval 25.0 to 41.4
|
24 titer
Interval 18.0 to 30.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5, 1 Year Post Vax 2
|
57 titer
Interval 44.5 to 73.2
|
42 titer
Interval 32.2 to 55.6
|
—
|
|
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
|
279 titer
Interval 203.4 to 383.4
|
58 titer
Interval 41.9 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 6A, 1 Year Post Vax 2
|
256 titer
Interval 191.2 to 341.9
|
113 titer
Interval 82.5 to 155.2
|
—
|
|
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
|
403 titer
Interval 290.6 to 558.3
|
186 titer
Interval 131.1 to 264.3
|
—
|
|
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
|
511 titer
Interval 376.9 to 693.4
|
361 titer
Interval 263.4 to 495.7
|
—
|
|
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 46.3 to 95.3
|
66 titer
Interval 45.5 to 95.0
|
—
|
|
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
|
76 titer
Interval 51.6 to 112.9
|
69 titer
Interval 47.3 to 100.9
|
—
|
|
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
|
130 titer
Interval 96.1 to 176.2
|
144 titer
Interval 104.7 to 198.7
|
—
|
|
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
|
204 titer
Interval 155.6 to 268.5
|
240 titer
Interval 180.7 to 319.3
|
—
|
|
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
|
436 titer
Interval 340.9 to 556.7
|
271 titer
Interval 197.8 to 371.7
|
—
|
|
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
|
185 titer
Interval 152.8 to 222.9
|
124 titer
Interval 97.4 to 158.3
|
—
|
|
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
|
235 titer
Interval 196.4 to 282.2
|
181 titer
Interval 146.7 to 223.8
|
—
|
|
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
|
121 titer
Interval 91.1 to 160.0
|
84 titer
Interval 61.6 to 115.4
|
—
|
|
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
|
261 titer
Interval 204.9 to 333.7
|
159 titer
Interval 119.0 to 211.4
|
—
|
|
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
|
60 titer
Interval 44.5 to 81.1
|
30 titer
Interval 22.3 to 41.0
|
—
|
|
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
|
104 titer
Interval 78.0 to 137.4
|
46 titer
Interval 33.9 to 61.8
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=127 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=199 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 9V, 1 Month Post Vax 1
|
1055 titer
Interval 740.6 to 1502.7
|
801 titer
Interval 589.0 to 1090.0
|
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 14, 1 Year Post Vax 2
|
387 titer
Interval 277.1 to 540.7
|
435 titer
Interval 329.4 to 575.6
|
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
|
1603 titer
Interval 1153.7 to 2226.2
|
1614 titer
Interval 1230.2 to 2117.7
|
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 19A, 1 Month Post Vax 1
|
698 titer
Interval 522.4 to 932.2
|
781 titer
Interval 662.0 to 920.4
|
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
|
229 titer
Interval 176.7 to 295.9
|
228 titer
Interval 185.8 to 280.7
|
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
|
54 titer
Interval 40.6 to 71.4
|
47 titer
Interval 37.5 to 60.0
|
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 59.1 to 95.5
|
75 titer
Interval 61.6 to 91.6
|
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
|
19 titer
Interval 14.8 to 23.3
|
27 titer
Interval 22.5 to 32.8
|
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
|
2546 titer
Interval 1908.6 to 3395.8
|
2575 titer
Interval 2075.2 to 3195.9
|
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
|
346 titer
Interval 242.6 to 493.7
|
405 titer
Interval 304.4 to 538.3
|
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
|
153 titer
Interval 101.6 to 229.5
|
255 titer
Interval 190.1 to 341.4
|
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 18C, 1 Year Post Vax 2
|
409 titer
Interval 281.0 to 596.0
|
560 titer
Interval 424.2 to 739.8
|
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 Year Post Vax 2
|
243 titer
Interval 185.7 to 319.1
|
310 titer
Interval 260.8 to 369.0
|
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
|
530 titer
Interval 361.7 to 775.7
|
845 titer
Interval 661.8 to 1079.9
|
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
|
239 titer
Interval 166.7 to 342.6
|
416 titer
Interval 333.0 to 519.7
|
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
|
339 titer
Interval 219.9 to 521.8
|
367 titer
Interval 268.3 to 501.2
|
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
|
105 titer
Interval 69.5 to 159.3
|
70 titer
Interval 52.0 to 95.0
|
39 titer
Interval 27.6 to 53.8
|
|
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 5, 1 Year Post Vax 2
|
26 titer
Interval 18.5 to 37.8
|
69 titer
Interval 52.4 to 91.8
|
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
|
2757 titer
Interval 2027.3 to 3750.3
|
3022 titer
Interval 2356.7 to 3875.6
|
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
|
286 titer
Interval 195.1 to 418.1
|
235 titer
Interval 171.4 to 320.9
|
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
|
1739 titer
Interval 1176.0 to 2570.2
|
1969 titer
Interval 1512.1 to 2562.7
|
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
|
855 titer
Interval 595.2 to 1227.5
|
697 titer
Interval 523.9 to 926.4
|
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
|
906 titer
Interval 590.6 to 1388.7
|
1459 titer
Interval 1147.2 to 1855.1
|
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
|
231 titer
Interval 148.8 to 359.6
|
398 titer
Interval 301.1 to 527.0
|
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 Year Post Vax 2
|
203 titer
Interval 127.4 to 322.0
|
224 titer
Interval 155.1 to 322.3
|
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 14, 1 Month Post Vax 1
|
614 titer
Interval 409.0 to 921.9
|
727 titer
Interval 527.6 to 1000.7
|
748 titer
Interval 535.4 to 1045.9
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=214 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 1, 1 Month Post Vax 1
|
92 titer
Interval 72.4 to 118.0
|
53 titer
Interval 41.5 to 68.2
|
—
|
|
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 1, 1 Year Post Vax 2
|
39 titer
Interval 31.5 to 48.6
|
22 titer
Interval 17.5 to 28.0
|
—
|
|
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 3, 1 Month Post Vax 1
|
52 titer
Interval 42.2 to 63.2
|
51 titer
Interval 41.5 to 63.5
|
—
|
|
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 3, 1 Year Post Vax 2
|
19 titer
Interval 16.2 to 23.4
|
16 titer
Interval 13.1 to 19.1
|
—
|
|
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 4, 1 Month Post Vax 1
|
511 titer
Interval 374.5 to 697.2
|
216 titer
Interval 151.2 to 308.2
|
—
|
|
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
|
271 titer
Interval 203.9 to 361.3
|
185 titer
Interval 136.2 to 249.9
|
—
|
|
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 5, 1 Month Post Vax 1
|
84 titer
Interval 64.7 to 108.8
|
42 titer
Interval 31.6 to 55.2
|
—
|
|
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 5, 1 Year Post Vax 2
|
58 titer
Interval 45.6 to 75.0
|
42 titer
Interval 31.9 to 55.2
|
—
|
|
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 6A, 1 Month Post Vax 1
|
975 titer
Interval 715.1 to 1328.4
|
106 titer
Interval 75.2 to 149.1
|
—
|
|
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 6A, 1 Year Post Vax 2
|
264 titer
Interval 197.8 to 353.4
|
115 titer
Interval 84.3 to 158.2
|
—
|
|
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 6B, 1 Month Post Vax 1
|
1331 titer
Interval 981.1 to 1806.1
|
465 titer
Interval 333.3 to 648.1
|
—
|
|
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
|
553 titer
Interval 411.3 to 743.9
|
396 titer
Interval 289.7 to 540.2
|
—
|
|
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 7F, 1 Month Post Vax 1
|
328 titer
Interval 233.5 to 459.8
|
195 titer
Interval 134.4 to 281.9
|
—
|
|
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 Year Post Vax 2
|
165 titer
Interval 119.3 to 227.8
|
112 titer
Interval 79.2 to 159.1
|
—
|
|
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 9V, 1 Month Post Vax 1
|
193 titer
Interval 131.4 to 282.8
|
102 titer
Interval 68.2 to 152.2
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 9V, 1 Year Post Vax 2
|
82 titer
Interval 55.3 to 121.8
|
69 titer
Interval 46.9 to 101.2
|
—
|
|
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 Month Post Vax 1
|
241 titer
Interval 179.4 to 325.0
|
280 titer
Interval 203.3 to 384.3
|
—
|
|
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 14, 1 Year Post Vax 2
|
205 titer
Interval 155.8 to 270.6
|
236 titer
Interval 175.5 to 318.0
|
—
|
|
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
|
946 titer
Interval 749.2 to 1195.4
|
555 titer
Interval 405.8 to 759.9
|
—
|
|
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 18C, 1 Year Post Vax 2
|
544 titer
Interval 435.5 to 679.5
|
370 titer
Interval 276.9 to 495.3
|
—
|
|
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 19A, 1 Month Post Vax 1
|
381 titer
Interval 312.9 to 462.9
|
199 titer
Interval 157.3 to 251.4
|
—
|
|
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 19A, 1 Year Post Vax 2
|
232 titer
Interval 192.7 to 279.3
|
180 titer
Interval 145.9 to 222.1
|
—
|
|
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 19F, 1 Month Post Vax 1
|
407 titer
Interval 312.1 to 531.7
|
238 titer
Interval 177.4 to 320.2
|
—
|
|
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 19F, 1 Year Post Vax 2
|
281 titer
Interval 219.7 to 358.5
|
158 titer
Interval 118.2 to 211.0
|
—
|
|
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 23F, 1 Month Post Vax 1
|
173 titer
Interval 125.5 to 239.6
|
48 titer
Interval 35.2 to 65.6
|
—
|
|
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
|
106 titer
Interval 79.7 to 141.5
|
45 titer
Interval 33.0 to 60.2
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=127 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
7 titer
Interval 5.6 to 7.9
|
6 titer
Interval 5.4 to 7.1
|
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
|
54 titer
Interval 40.8 to 70.4
|
52 titer
Interval 40.9 to 65.5
|
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 5.0 to 6.9
|
6 titer
Interval 5.3 to 7.0
|
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
|
19 titer
Interval 14.9 to 23.5
|
27 titer
Interval 22.1 to 32.3
|
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
|
24 titer
Interval 14.7 to 40.3
|
36 titer
Interval 23.8 to 54.0
|
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
|
314 titer
Interval 208.6 to 472.1
|
323 titer
Interval 233.9 to 445.7
|
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
|
5 titer
Interval 4.2 to 5.3
|
6 titer
Interval 5.2 to 6.9
|
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
|
29 titer
Interval 20.4 to 41.4
|
75 titer
Interval 57.4 to 99.2
|
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
|
21 titer
Interval 13.5 to 31.9
|
17 titer
Interval 12.4 to 24.6
|
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
|
313 titer
Interval 210.4 to 464.4
|
214 titer
Interval 153.1 to 298.7
|
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
|
35 titer
Interval 20.6 to 58.4
|
24 titer
Interval 16.7 to 35.7
|
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
|
720 titer
Interval 474.8 to 1090.7
|
522 titer
Interval 378.0 to 719.8
|
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
|
7 titer
Interval 5.4 to 10.0
|
8 titer
Interval 6.3 to 10.5
|
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
|
238 titer
Interval 152.5 to 370.7
|
384 titer
Interval 290.3 to 508.9
|
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 9.5 to 22.5
|
15 titer
Interval 10.7 to 21.5
|
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
|
187 titer
Interval 116.1 to 301.9
|
192 titer
Interval 130.6 to 283.3
|
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
|
27 titer
Interval 17.6 to 42.5
|
34 titer
Interval 23.1 to 48.6
|
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
|
350 titer
Interval 249.6 to 489.5
|
385 titer
Interval 286.5 to 518.5
|
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
|
20 titer
Interval 13.5 to 29.7
|
25 titer
Interval 17.8 to 33.8
|
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
|
400 titer
Interval 274.2 to 584.1
|
546 titer
Interval 415.3 to 718.0
|
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
|
20 titer
Interval 14.6 to 28.6
|
25 titer
Interval 19.1 to 32.9
|
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
|
245 titer
Interval 188.5 to 319.5
|
327 titer
Interval 273.7 to 391.0
|
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
|
20 titer
Interval 13.1 to 29.0
|
24 titer
Interval 17.3 to 33.4
|
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
|
237 titer
Interval 165.0 to 340.7
|
415 titer
Interval 332.9 to 516.2
|
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
|
10 titer
Interval 7.0 to 13.0
|
9 titer
Interval 7.1 to 11.2
|
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
|
114 titer
Interval 75.4 to 172.9
|
59 titer
Interval 43.9 to 80.6
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=218 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 1, Pre Vax 1
|
10 titer
Interval 8.7 to 12.4
|
10 titer
Interval 7.9 to 11.5
|
—
|
|
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
|
38 titer
Interval 30.9 to 47.9
|
22 titer
Interval 17.6 to 28.1
|
—
|
|
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
|
9 titer
Interval 7.7 to 11.0
|
10 titer
Interval 8.6 to 12.2
|
—
|
|
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
|
20 titer
Interval 16.4 to 23.5
|
16 titer
Interval 12.9 to 18.7
|
—
|
|
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
|
30 titer
Interval 20.4 to 42.9
|
27 titer
Interval 19.0 to 38.7
|
—
|
|
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
|
238 titer
Interval 176.8 to 319.4
|
160 titer
Interval 117.1 to 219.2
|
—
|
|
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
|
12 titer
Interval 9.3 to 14.6
|
14 titer
Interval 10.8 to 17.6
|
—
|
|
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
|
57 titer
Interval 44.4 to 73.2
|
43 titer
Interval 32.7 to 56.7
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 6A, Pre Vax 1
|
22 titer
Interval 16.0 to 29.7
|
31 titer
Interval 22.1 to 42.6
|
—
|
|
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
|
259 titer
Interval 192.7 to 346.9
|
108 titer
Interval 78.4 to 148.3
|
—
|
|
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
|
79 titer
Interval 54.1 to 113.9
|
123 titer
Interval 84.0 to 179.4
|
—
|
|
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
|
507 titer
Interval 368.6 to 696.7
|
385 titer
Interval 278.9 to 531.9
|
—
|
|
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
|
23 titer
Interval 16.4 to 32.1
|
21 titer
Interval 14.7 to 28.9
|
—
|
|
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
|
169 titer
Interval 122.3 to 232.4
|
115 titer
Interval 81.7 to 163.2
|
—
|
|
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
|
21 titer
Interval 14.4 to 29.9
|
23 titer
Interval 15.9 to 32.6
|
—
|
|
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
|
75 titer
Interval 50.5 to 111.3
|
66 titer
Interval 45.3 to 97.4
|
—
|
|
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
|
70 titer
Interval 49.9 to 97.8
|
79 titer
Interval 55.5 to 111.2
|
—
|
|
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
|
202 titer
Interval 153.2 to 266.8
|
224 titer
Interval 167.0 to 299.6
|
—
|
|
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
|
131 titer
Interval 95.8 to 178.3
|
145 titer
Interval 103.9 to 201.9
|
—
|
|
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
|
530 titer
Interval 425.0 to 660.6
|
368 titer
Interval 277.8 to 488.9
|
—
|
|
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
|
79 titer
Interval 62.4 to 101.1
|
66 titer
Interval 50.9 to 85.3
|
—
|
|
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
|
236 titer
Interval 197.3 to 283.1
|
175 titer
Interval 141.8 to 216.8
|
—
|
|
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
|
46 titer
Interval 33.2 to 62.9
|
37 titer
Interval 27.6 to 50.9
|
—
|
|
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
|
272 titer
Interval 212.8 to 346.8
|
151 titer
Interval 112.6 to 201.6
|
—
|
|
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
|
14 titer
Interval 11.1 to 18.4
|
16 titer
Interval 12.5 to 21.6
|
—
|
|
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
|
99 titer
Interval 74.0 to 131.6
|
45 titer
Interval 33.7 to 61.1
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=209 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
52 titer
Interval 40.9 to 65.5
|
36 titer
Interval 27.1 to 46.7
|
—
|
|
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 3
|
27 titer
Interval 22.2 to 32.3
|
18 titer
Interval 14.4 to 21.9
|
—
|
|
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 4
|
355 titer
Interval 264.7 to 475.9
|
183 titer
Interval 127.7 to 263.2
|
—
|
|
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 5
|
76 titer
Interval 58.0 to 99.7
|
44 titer
Interval 32.9 to 59.6
|
—
|
|
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
|
225 titer
Interval 163.6 to 308.3
|
102 titer
Interval 71.4 to 146.9
|
—
|
|
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 6B
|
593 titer
Interval 441.4 to 797.3
|
324 titer
Interval 225.0 to 466.1
|
—
|
|
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
|
412 titer
Interval 313.1 to 541.2
|
145 titer
Interval 100.3 to 210.7
|
—
|
|
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 9V
|
221 titer
Interval 154.2 to 316.0
|
129 titer
Interval 84.5 to 196.5
|
—
|
|
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 14
|
416 titer
Interval 316.2 to 548.2
|
383 titer
Interval 286.9 to 510.6
|
—
|
|
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
|
527 titer
Interval 401.7 to 690.5
|
337 titer
Interval 240.7 to 471.7
|
—
|
|
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 19A
|
313 titer
Interval 263.1 to 372.3
|
170 titer
Interval 134.4 to 214.8
|
—
|
|
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
|
426 titer
Interval 343.7 to 527.7
|
195 titer
Interval 145.1 to 262.1
|
—
|
|
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
|
64 titer
Interval 47.6 to 86.5
|
35 titer
Interval 25.6 to 48.6
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=129 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 19F
|
256 titer
Interval 182.4 to 359.0
|
195 titer
Interval 145.1 to 262.1
|
—
|
|
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 23F
|
110 titer
Interval 73.9 to 165.0
|
35 titer
Interval 25.6 to 48.6
|
—
|
|
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
|
54 titer
Interval 40.8 to 71.0
|
36 titer
Interval 27.1 to 46.7
|
—
|
|
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
|
19 titer
Interval 15.0 to 23.5
|
18 titer
Interval 14.4 to 21.9
|
—
|
|
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 4
|
328 titer
Interval 229.0 to 469.0
|
183 titer
Interval 127.7 to 263.2
|
—
|
|
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 5
|
29 titer
Interval 20.4 to 41.4
|
44 titer
Interval 32.9 to 59.6
|
—
|
|
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
|
316 titer
Interval 216.5 to 461.2
|
102 titer
Interval 71.4 to 146.9
|
—
|
|
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 6B
|
785 titer
Interval 540.6 to 1140.2
|
324 titer
Interval 225.0 to 466.1
|
—
|
|
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 7F
|
247 titer
Interval 160.4 to 380.9
|
145 titer
Interval 100.3 to 210.7
|
—
|
|
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
|
211 titer
Interval 134.3 to 330.9
|
129 titer
Interval 84.5 to 196.5
|
—
|
|
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 14
|
379 titer
Interval 273.6 to 526.2
|
383 titer
Interval 286.9 to 510.6
|
—
|
|
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
|
393 titer
Interval 271.3 to 569.3
|
337 titer
Interval 240.7 to 471.7
|
—
|
|
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
|
244 titer
Interval 189.1 to 314.1
|
170 titer
Interval 134.4 to 214.8
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=129 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
54 titer
Interval 40.8 to 71.0
|
52 titer
Interval 40.9 to 65.5
|
—
|
|
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 3
|
19 titer
Interval 15.0 to 23.5
|
27 titer
Interval 22.2 to 32.3
|
—
|
|
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 4
|
328 titer
Interval 229.0 to 469.0
|
355 titer
Interval 264.7 to 475.9
|
—
|
|
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 5
|
29 titer
Interval 20.4 to 41.4
|
76 titer
Interval 58.0 to 99.7
|
—
|
|
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
|
316 titer
Interval 216.5 to 461.2
|
225 titer
Interval 163.6 to 308.3
|
—
|
|
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 6B
|
785 titer
Interval 540.6 to 1140.2
|
593 titer
Interval 441.4 to 797.3
|
—
|
|
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 7F
|
247 titer
Interval 160.4 to 380.9
|
412 titer
Interval 313.1 to 541.2
|
—
|
|
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 9V
|
211 titer
Interval 134.3 to 330.9
|
221 titer
Interval 154.2 to 316.0
|
—
|
|
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 14
|
379 titer
Interval 273.6 to 526.2
|
416 titer
Interval 316.2 to 548.2
|
—
|
|
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
|
393 titer
Interval 271.3 to 569.3
|
527 titer
Interval 401.7 to 690.5
|
—
|
|
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 19A
|
244 titer
Interval 189.1 to 314.1
|
313 titer
Interval 263.1 to 372.3
|
—
|
|
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 19F
|
256 titer
Interval 182.4 to 359.0
|
426 titer
Interval 343.7 to 527.7
|
—
|
|
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
|
110 titer
Interval 73.9 to 165.0
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=220 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
38 titer
Interval 30.9 to 47.9
|
22 titer
Interval 17.5 to 27.8
|
—
|
|
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
|
20 titer
Interval 16.5 to 23.4
|
16 titer
Interval 13.3 to 19.2
|
—
|
|
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 4
|
265 titer
Interval 200.8 to 348.5
|
172 titer
Interval 129.0 to 230.1
|
—
|
|
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 5
|
58 titer
Interval 45.1 to 74.1
|
42 titer
Interval 32.2 to 55.6
|
—
|
|
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
|
250 titer
Interval 187.3 to 334.0
|
115 titer
Interval 84.5 to 156.8
|
—
|
|
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
|
510 titer
Interval 378.2 to 686.4
|
381 titer
Interval 281.9 to 513.9
|
—
|
|
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 7F
|
173 titer
Interval 126.0 to 237.5
|
115 titer
Interval 81.6 to 160.9
|
—
|
|
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 9V
|
81 titer
Interval 55.1 to 117.9
|
68 titer
Interval 47.4 to 98.5
|
—
|
|
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 14
|
202 titer
Interval 154.6 to 265.0
|
240 titer
Interval 181.0 to 317.0
|
—
|
|
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
|
540 titer
Interval 435.5 to 668.5
|
360 titer
Interval 273.6 to 474.5
|
—
|
|
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
|
232 titer
Interval 193.2 to 278.1
|
181 titer
Interval 146.7 to 222.9
|
—
|
|
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 19F
|
277 titer
Interval 218.6 to 351.7
|
158 titer
Interval 119.3 to 209.9
|
—
|
|
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 23F
|
103 titer
Interval 78.0 to 135.0
|
45 titer
Interval 33.5 to 69.6
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=209 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=175 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
52 titer
Interval 40.9 to 65.5
|
45 titer
Interval 34.5 to 59.8
|
—
|
|
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
|
27 titer
Interval 22.2 to 32.3
|
26 titer
Interval 20.4 to 32.5
|
—
|
|
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 4
|
355 titer
Interval 264.7 to 475.9
|
332 titer
Interval 231.8 to 476.2
|
—
|
|
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 5
|
76 titer
Interval 58.0 to 99.7
|
49 titer
Interval 36.4 to 66.9
|
—
|
|
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 6A
|
225 titer
Interval 163.6 to 308.3
|
82 titer
Interval 54.6 to 122.4
|
—
|
|
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
|
593 titer
Interval 441.4 to 797.3
|
162 titer
Interval 108.9 to 241.6
|
—
|
|
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
|
412 titer
Interval 313.1 to 541.2
|
66 titer
Interval 44.1 to 100.1
|
—
|
|
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
|
221 titer
Interval 154.2 to 316.0
|
52 titer
Interval 33.7 to 80.3
|
—
|
|
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 14
|
416 titer
Interval 316.2 to 548.2
|
302 titer
Interval 214.2 to 425.3
|
—
|
|
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 18C
|
527 titer
Interval 401.7 to 690.5
|
319 titer
Interval 222.5 to 457.3
|
—
|
|
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 19A
|
313 titer
Interval 263.1 to 372.3
|
153 titer
Interval 117.3 to 199.5
|
—
|
|
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 19F
|
426 titer
Interval 343.7 to 527.7
|
125 titer
Interval 88.8 to 176.5
|
—
|
|
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 23F
|
64 titer
Interval 47.6 to 86.5
|
30 titer
Interval 21.2 to 42.1
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=179 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 5
|
44 titer
Interval 32.9 to 59.6
|
52 titer
Interval 40.9 to 64.8
|
—
|
|
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 6A
|
102 titer
Interval 71.4 to 146.9
|
597 titer
Interval 466.8 to 764.7
|
—
|
|
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 6B
|
324 titer
Interval 225.0 to 466.1
|
420 titer
Interval 320.2 to 552.0
|
—
|
|
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
|
145 titer
Interval 100.3 to 210.7
|
133 titer
Interval 99.6 to 177.8
|
—
|
|
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 9V
|
129 titer
Interval 84.5 to 196.5
|
85 titer
Interval 62.7 to 115.4
|
—
|
|
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
|
383 titer
Interval 286.9 to 510.6
|
250 titer
Interval 193.5 to 324.2
|
—
|
|
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 18C
|
337 titer
Interval 240.7 to 471.7
|
439 titer
Interval 349.8 to 551.0
|
—
|
|
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
|
170 titer
Interval 134.4 to 214.8
|
208 titer
Interval 175.9 to 245.7
|
—
|
|
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 19F
|
195 titer
Interval 145.1 to 262.1
|
147 titer
Interval 115.1 to 187.7
|
—
|
|
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 23F
|
35 titer
Interval 25.6 to 48.6
|
90 titer
Interval 69.9 to 116.6
|
—
|
|
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 1
|
36 titer
Interval 27.1 to 46.7
|
54 titer
Interval 45.4 to 65.0
|
—
|
|
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
|
18 titer
Interval 14.4 to 21.9
|
21 titer
Interval 18.1 to 24.9
|
—
|
|
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
|
183 titer
Interval 127.7 to 263.2
|
622 titer
Interval 496.9 to 777.7
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=124 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 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
|
—
|
—
|
|
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
|
—
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=222 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
22 titer
Interval 17.5 to 27.8
|
33 titer
Interval 26.6 to 41.3
|
—
|
|
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 13.3 to 19.2
|
16 titer
Interval 13.5 to 19.6
|
—
|
|
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 4
|
172 titer
Interval 129.0 to 230.1
|
123 titer
Interval 85.4 to 177.6
|
—
|
|
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 5
|
42 titer
Interval 32.2 to 55.6
|
31 titer
Interval 24.4 to 40.2
|
—
|
|
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 6A
|
115 titer
Interval 84.5 to 156.8
|
271 titer
Interval 197.5 to 370.6
|
—
|
|
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 6B
|
381 titer
Interval 281.9 to 513.9
|
380 titer
Interval 274.0 to 526.3
|
—
|
|
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
|
115 titer
Interval 81.6 to 160.9
|
61 titer
Interval 43.0 to 87.7
|
—
|
|
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
|
68 titer
Interval 47.4 to 98.5
|
40 titer
Interval 27.8 to 58.3
|
—
|
|
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
|
240 titer
Interval 181.0 to 317.0
|
126 titer
Interval 93.0 to 170.7
|
—
|
|
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
|
360 titer
Interval 273.6 to 474.5
|
439 titer
Interval 343.4 to 559.9
|
—
|
|
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 19A
|
181 titer
Interval 146.7 to 222.9
|
183 titer
Interval 151.3 to 220.7
|
—
|
|
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
|
158 titer
Interval 119.3 to 209.9
|
115 titer
Interval 87.4 to 151.3
|
—
|
|
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
|
45 titer
Interval 33.5 to 59.6
|
59 titer
Interval 43.7 to 79.4
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=217 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=332 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS Group (23vPS Naïve)
n=175 Participants
Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
54 titer
Interval 45.4 to 65.0
|
45 titer
Interval 34.5 to 59.8
|
—
|
|
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 3
|
21 titer
Interval 18.1 to 24.9
|
26 titer
Interval 20.4 to 32.5
|
—
|
|
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
|
622 titer
Interval 496.9 to 777.7
|
332 titer
Interval 231.8 to 476.2
|
—
|
|
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 5
|
52 titer
Interval 40.9 to 64.8
|
49 titer
Interval 36.4 to 66.9
|
—
|
|
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 6A
|
597 titer
Interval 466.8 to 764.7
|
82 titer
Interval 54.6 to 122.4
|
—
|
|
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 6B
|
420 titer
Interval 320.2 to 552.0
|
162 titer
Interval 108.9 to 241.6
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 7F
|
133 titer
Interval 99.6 to 177.8
|
66 titer
Interval 44.1 to 100.1
|
—
|
|
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
|
85 titer
Interval 62.7 to 115.4
|
52 titer
Interval 33.7 to 80.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 14
|
250 titer
Interval 193.5 to 324.2
|
302 titer
Interval 214.2 to 425.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 18C
|
439 titer
Interval 349.8 to 551.0
|
319 titer
Interval 222.5 to 457.3
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Serotype 19A
|
208 titer
Interval 175.9 to 245.7
|
153 titer
Interval 117.3 to 199.5
|
—
|
|
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
|
147 titer
Interval 115.1 to 187.7
|
125 titer
Interval 88.8 to 176.5
|
—
|
|
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
|
90 titer
Interval 69.9 to 116.6
|
30 titer
Interval 21.2 to 42.1
|
—
|
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 |
13vPnC/13vPnC Group (23vPs Naïve)
n=220 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 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
|
13vPnC/23vPS 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 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
|
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
|
33 titer
Interval 26.6 to 41.3
|
21 titer
Interval 16.8 to 26.5
|
—
|
|
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 13.5 to 19.6
|
16 titer
Interval 13.2 to 19.8
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 4
|
123 titer
Interval 85.4 to 177.6
|
68 titer
Interval 47.0 to 96.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 5
|
31 titer
Interval 24.4 to 40.2
|
23 titer
Interval 17.6 to 29.7
|
—
|
|
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 6A
|
271 titer
Interval 197.5 to 370.6
|
57 titer
Interval 40.9 to 78.2
|
—
|
|
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 6B
|
380 titer
Interval 274.0 to 526.3
|
168 titer
Interval 118.6 to 238.1
|
—
|
|
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
|
61 titer
Interval 43.0 to 87.7
|
63 titer
Interval 43.8 to 91.1
|
—
|
|
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
|
40 titer
Interval 27.8 to 58.3
|
29 titer
Interval 20.3 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 14
|
126 titer
Interval 93.0 to 170.7
|
140 titer
Interval 101.7 to 192.7
|
—
|
|
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 18C
|
439 titer
Interval 343.4 to 559.9
|
271 titer
Interval 197.8 to 371.7
|
—
|
|
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
|
183 titer
Interval 151.3 to 220.7
|
122 titer
Interval 96.0 to 155.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 19F
|
115 titer
Interval 87.4 to 151.3
|
86 titer
Interval 63.2 to 115.9
|
—
|
|
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)
Serotype 23F
|
59 titer
Interval 43.7 to 79.4
|
30 titer
Interval 22.3 to 41.0
|
—
|
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