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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01025336

First received: November 20, 2009

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Results First Received: May 16, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Healthy
Intervention:	Other: Blood draw

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
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)

Participant Flow: Overall Study

	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
STARTED	130	210	179	221	222
COMPLETED	130	210	179	219	222
NOT COMPLETED	0	0	0	2	0
Protocol Violation	0	0	0	2	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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)
Total	Total of all reporting groups

Baseline Measures

	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	Total
Number of Participants [units: participants]	130	210	179	221	222	962
Age [units: Years] Mean ± Standard Deviation	64.0 ± 1.4	64.1 ± 1.4	64.2 ± 1.4	78.3 ± 4.5	77.8 ± 4.1	70.5 ± 7.6
Gender [units: Participants]
Female	76	125	102	114	115	532
Male	54	85	77	107	107	430

Outcome Measures

Show All Outcome Measures

1. Primary:

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548) [ Time Frame: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 1

2. Primary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572) [ Time Frame: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 2

3. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336) ]

Show Outcome Measure 3

4. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) [ Time Frame: Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336) ]

Hide Outcome Measure 4

Measure Type	Secondary
Measure Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Measure Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame	Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 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 at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)

Measured Values

	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Number of Participants Analyzed [units: participants]	216	217
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) [units: titer] Geometric Mean ( 95% Confidence Interval )
Serotype 1, 1 Month Post Vax 2	80 ( 65.0 to 97.7 )	34 ( 27.2 to 43.7 )
Serotype 1, 1 Year Post Vax 2	39 ( 31.1 to 48.2 )	22 ( 17.4 to 27.6 )
Serotype 3, 1 Month Post Vax 2	50 ( 42.1 to 59.2 )	32 ( 26.1 to 38.9 )
Serotype 3, 1 Year Post Vax 2	20 ( 16.5 to 23.6 )	16 ( 13.2 to 19.1 )
Serotype 4, 1 Month Post Vax 2	437 ( 332.0 to 576.3 )	237 ( 173.5 to 325.1 )
Serotype 4, 1 Year Post Vax 2	311 ( 238.1 to 407.1 )	186 ( 138.3 to 250.2 )
Serotype 5, 1 Month Post Vax 2	62 ( 48.1 to 79.4 )	49 ( 37.4 to 63.7 )
Serotype 5, 1 Year Post Vax 2	58 ( 45.0 to 74.4 )	42 ( 31.7 to 54.8 )
Serotype 6A, 1 Month Post Vax 2	1088 ( 843.2 to 1404.7 )	569 ( 421.8 to 768.5 )
Serotype 6A, 1 Year Post Vax 2	257 ( 192.4 to 342.9 )	133 ( 97.4 to 182.1 )
Serotype 6B, 1 Month Post Vax 2	1516 ( 1173.7 to 1957.5 )	781 ( 574.8 to 1061.9 )
Serotype 6B, 1 Year Post Vax 2	561 ( 421.4 to 746.9 )	381 ( 282.6 to 514.5 )
Serotype 7F, 1 Month Post Vax 2	233 ( 166.5 to 324.8 )	135 ( 93.2 to 194.5 )
Serotype 7F, 1 Year Post Vax 2	173 ( 125.9 to 239.1 )	117 ( 82.8 to 165.4 )
Serotype 9V, 1 Month Post Vax 2	166 ( 113.8 to 241.5 )	91 ( 62.0 to 133.3 )
Serotype 9V, 1 Year Post Vax 2	83 ( 56.2 to 121.9 )	73 ( 49.9 to 105.9 )
Serotype 14, 1 Month Post Vax 2	216 ( 163.8 to 284.3 )	199 ( 146.9 to 270.8 )
Serotype 14, 1 Year Post Vax 2	209 ( 159.5 to 272.9 )	244 ( 184.5 to 321.9 )
Serotype 18C, 1 Month Post Vax 2	1015 ( 832.6 to 1237.6 )	523 ( 395.1 to 693.5 )
Serotype 18C, 1 Year Post Vax 2	553 ( 446.5 to 685.6 )	366 ( 277.2 to 482.9 )
Serotype 19A, 1 Month Post Vax 2	356 ( 297.6 to 425.6 )	255 ( 207.8 to 313.7 )
Serotype 19A, 1 Year Post Vax 2	228 ( 189.1 to 276.1 )	182 ( 147.7 to 225.2 )
Serotype 19F, 1 Month Post Vax 2	349 ( 274.7 to 444.5 )	178 ( 134.1 to 235.0 )
Serotype 19F, 1 Year Post Vax 2	274 ( 214.2 to 350.8 )	158 ( 119.1 to 210.6 )
Serotype 23F, 1 Month Post Vax 2	324 ( 250.8 to 419.8 )	113 ( 82.4 to 154.8 )
Serotype 23F, 1 Year Post Vax 2	102 ( 77.0 to 135.0 )	46 ( 33.9 to 61.7 )

Statistical Analysis 1 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.5
95% Confidence Interval	( 0.42 to 0.56 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.6
95% Confidence Interval	( 0.56 to 0.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.4
95% Confidence Interval	( 0.35 to 0.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.5
95% Confidence Interval	( 0.44 to 0.57 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.7
95% Confidence Interval	( 0.60 to 0.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.8
95% Confidence Interval	( 0.63 to 0.97 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.9
95% Confidence Interval	( 0.81 to 1.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.9
95% Confidence Interval	( 0.74 to 0.99 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.2
95% Confidence Interval	( 0.19 to 0.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.2
95% Confidence Interval	( 0.19 to 0.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 11 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.4
95% Confidence Interval	( 0.31 to 0.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.5
95% Confidence Interval	( 0.40 to 0.59 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.7
95% Confidence Interval	( 0.58 to 0.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 14 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.9
95% Confidence Interval	( 0.67 to 1.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 15 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.5
95% Confidence Interval	( 0.37 to 0.67 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 16 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.8
95% Confidence Interval	( 0.57 to 1.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 17 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	1.0
95% Confidence Interval	( 0.85 to 1.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 18 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	1.2
95% Confidence Interval	( 1.04 to 1.43 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 19 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.5
95% Confidence Interval	( 0.48 to 0.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 20 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.7
95% Confidence Interval	( 0.59 to 0.83 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 21 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.6
95% Confidence Interval	( 0.57 to 0.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 22 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.7
95% Confidence Interval	( 0.65 to 0.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 23 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.8
95% Confidence Interval	( 0.66 to 0.93 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 24 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.9
95% Confidence Interval	( 0.75 to 1.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 25 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.3
95% Confidence Interval	( 0.27 to 0.37 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 26 for Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)

Groups ^[1]	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Geometric mean fold rise ^[2]	0.4
95% Confidence Interval	( 0.34 to 0.48 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
[2]	Other relevant estimation information:
	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

5. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 5

6. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) [ Time Frame: Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 6

7. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 7

8. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) [ Time Frame: Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 8

9. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 9

10. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) [ Time Frame: Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336) ]

Show Outcome Measure 10

11. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548) [ Time Frame: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 11

12. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 12

13. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548) [ Time Frame: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 13

14. Secondary:

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572) [ Time Frame: Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 14

15. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 15

16. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 16

17. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 17

18. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336) ]

Show Outcome Measure 18

19. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336) ]

Show Outcome Measure 19

20. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00574548) ]

Show Outcome Measure 20

21. Secondary:

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) [ Time Frame: Month 0/Year 1 (Parent Study NCT00546572) ]

Show Outcome Measure 21

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01025336 History of Changes
Other Study ID Numbers:	6115A1-3018, B1851029
Study First Received:	November 20, 2009
Results First Received:	May 16, 2012
Last Updated:	May 16, 2012
Health Authority:	United States: Food and Drug Administration

To Top