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

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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Healthy
• Intervention: Other: Blood draw
• Enrollment: 962

Participant Flow

Recruitment Details
Pre-assignment Details	Only participants who completed Parent Study 6115A1-3010 (NCT00574548) or Parent Study 6115A1-3005 (NCT00546572) were enrolled in this follow-up study 6115A1-3018 (NCT01025336).

Arm/Group Title	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Arm/Group Description	Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Period Title: Overall Study
Started	130	210	179	221	222
Completed	130	210	179	219	222
Not Completed	0	0	0	2	0
Reason Not Completed
Protocol Violation	0	0	0	2	0

Baseline Characteristics

Arm/Group Title		13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	Total
Arm/Group Description		Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Total of all reporting groups
Overall Number of Baseline Participants		130	210	179	221	222	962
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	130 participants	210 participants	179 participants	221 participants	222 participants	962 participants
		64.0 (1.4)	64.1 (1.4)	64.2 (1.4)	78.3 (4.5)	77.8 (4.1)	70.5 (7.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	130 participants	210 participants	179 participants	221 participants	222 participants	962 participants
	Female	76 58.5%	125 59.5%	102 57.0%	114 51.6%	115 51.8%	532 55.3%
	Male	54 41.5%	85 40.5%	77 43.0%	107 48.4%	107 48.2%	430 44.7%

Outcome Measures

1. Primary Outcome

Title	Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Time Frame	Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.

Arm/Group Title	13vPnC/13vPnC Group (23vPs Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)
Arm/Group Description:	Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	129	209	179
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1	54; (40.8 to 71.0)	52; (40.9 to 65.5)	36; (27.1 to 46.7)
Serotype 3	19; (15.0 to 23.5)	27; (22.2 to 32.3)	18; (14.4 to 21.9)
Serotype 4	328; (229.0 to 469.0)	355; (264.7 to 475.9)	183; (127.7 to 263.2)
Serotype 5	29; (20.4 to 41.4)	76; (58.0 to 99.7)	44; (32.9 to 59.6)
Serotype 6A	316; (216.5 to 461.2)	225; (163.6 to 308.3)	102; (71.4 to 146.9)
Serotype 6B	785; (540.6 to 1140.2)	593; (441.4 to 797.3)	324; (225.0 to 466.1)
Serotype 7F	247; (160.4 to 380.9)	412; (313.1 to 541.2)	145; (100.3 to 210.7)
Serotype 9V	211; (134.3 to 330.9)	221; (154.2 to 316.0)	129; (84.5 to 196.5)
Serotype 14	379; (273.6 to 526.2)	416; (316.2 to 548.2)	383; (286.9 to 510.6)
Serotype 18C	393; (271.3 to 569.3)	527; (401.7 to 690.5)	337; (240.7 to 471.7)
Serotype 19A	244; (189.1 to 314.1)	313; (263.1 to 372.3)	170; (134.4 to 214.8)
Serotype 19F	256; (182.4 to 359.0)	426; (343.7 to 527.7)	195; (145.1 to 262.1)
Serotype 23F	110; (73.9 to 165.0)	64; (47.6 to 86.5)	35; (25.6 to 48.6)

2. Primary Outcome

Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Time Frame	Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Arm/Group Description:	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	220	222
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1	38; (30.9 to 47.9)	22; (17.5 to 27.8)
Serotype 3	20; (16.5 to 23.4)	16; (13.3 to 19.2)
Serotype 4	265; (200.8 to 348.5)	172; (129.0 to 230.1)
Serotype 5	58; (45.1 to 74.1)	42; (32.2 to 55.6)
Serotype 6A	250; (187.3 to 334.0)	115; (84.5 to 156.8)
Serotype 6B	510; (378.2 to 686.4)	381; (281.9 to 513.9)
Serotype 7F	173; (126.0 to 237.5)	115; (81.6 to 160.9)
Serotype 9V	81; (55.1 to 117.9)	68; (47.4 to 98.5)
Serotype 14	202; (154.6 to 265.0)	240; (181.0 to 317.0)
Serotype 18C	540; (435.5 to 668.5)	360; (273.6 to 474.5)
Serotype 19A	232; (193.2 to 278.1)	181; (146.7 to 222.9)
Serotype 19F	277; (218.6 to 351.7)	158; (119.3 to 209.9)
Serotype 23F	103; (78.0 to 135.5)	45; (33.5 to 59.6)

3. Secondary Outcome

Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame	Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)
Arm/Group Description:	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	126	204	175
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1, 1 Month Post Vax 2	141; (110.4 to 179.7)	149; (123.5 to 180.6)	70; (53.4 to 91.2)
Serotype 1, 1 Year Post Vax 2	54; (40.7 to 70.4)	52; (41.1 to 66.1)	36; (27.6 to 47.9)
Serotype 3, 1 Month Post Vax 2	87; (73.7 to 103.8)	130; (112.8 to 150.3)	50; (40.2 to 63.1)
Serotype 3, 1 Year Post Vax 2	18; (14.6 to 22.9)	27; (22.2 to 32.5)	18; (14.5 to 22.2)
Serotype 4, 1 Month Post Vax 2	1284; (992.3 to 1661.9)	1375; (1137.0 to 1663.8)	898; (684.1 to 1179.5)
Serotype 4, 1 Year Post Vax 2	318; (220.9 to 458.7)	369; (276.1 to 493.9)	203; (142.0 to 291.4)
Serotype 5, 1 Month Post Vax 2	95; (67.1 to 133.2)	223; (180.7 to 276.3)	80; (59.7 to 108.3)
Serotype 5, 1 Year Post Vax 2	29; (20.3 to 42.5)	72; (54.6 to 95.1)	41; (30.3 to 56.2)
Serotype 6A, 1 Month Post Vax 2	2120; (1614.1 to 2783.9)	1307; (1021.4 to 1672.8)	933; (682.1 to 1276.2)
Serotype 6A, 1 Year Post Vax 2	304; (207.7 to 446.3)	266; (195.2 to 362.6)	115; (79.3 to 166.3)
Serotype 6B, 1 Month Post Vax 2	1683; (1253.6 to 2258.3)	1232; (965.9 to 1570.4)	740; (534.8 to 1024.2)
Serotype 6B, 1 Year Post Vax 2	847; (590.8 to 1214.8)	637; (476.3 to 851.6)	352; (244.8 to 505.5)
Serotype 7F, 1 Month Post Vax 2	306; (201.8 to 462.5)	667; (531.5 to 836.8)	131; (87.8 to 496.9)
Serotype 7F, 1 Year Post Vax 2	237; (152.2 to 369.9)	412; (313.2 to 541.5)	148; (101.4 to 215.1)
Serotype 9V, 1 Month Post Vax 2	385; (252.6 to 586.8)	419; (298.6 to 588.0)	122; (80.0 to 186.1)
Serotype 9V, 1 Year Post Vax 2	221; (139.8 to 350.8)	224; (155.9 to 321.6)	139; (90.6 to 213.1)
Serotype 14, 1 Month Post Vax 2	434; (311.6 to 605.6)	639; (487.8 to 836.3)	426; (312.7 to 580.5)
Serotype 14, 1 Year Post Vax 2	380; (273.4 to 528.8)	406; (306.7 to 537.0)	388; (290.7 to 517.2)
Serotype 18C, 1 Month Post Vax 2	972; (732.4 to 1290.1)	1092; (879.6 to 1356.2)	549; (395.9 to 761.1)
Serotype 18C, 1 Year Post Vax 2	373; (255.6 to 544.2)	513; (389.6 to 676.7)	331; (235.3 to 467.0)
Serotype 19A, 1 Month Post Vax 2	365; (295.0 to 450.7)	513; (445.6 to 590.5)	282; (230.3 to 344.4)
Serotype 19A, 1 Year Post Vax 2	213; (163.6 to 276.3)	295; (246.6 to 352.7)	167; (132.0 to 210.5)
Serotype 19F, 1 Month Post Vax 2	493; (365.0 to 664.7)	835; (685.5 to 1015.9)	264; (196.3 to 355.8)
Serotype 19F, 1 Year Post Vax 2	255; (180.5 to 360.8)	425; (340.9 to 529.2)	197; (146.4 to 266.2)
Serotype 23F, 1 Month Post Vax 2	543; (392.9 to 749.4)	218; (164.8 to 288.0)	109; (76.4 to 156.2)
Serotype 23F, 1 Year Post Vax 2	108; (71.9 to 162.3)	63; (46.4 to 84.5)	38; (27.1 to 52.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.46
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.41
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.61
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.25
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.24
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.41
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.19 to 0.32
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.33
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.30
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.25 to 0.39
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.27 to 0.38
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.60
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.20
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.25
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; 0.09 to 0.16
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.62
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.43 to 0.62
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.59
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.00
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.75
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.46
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.80
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.73
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.67
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.08
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.75
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.06
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.29 to 0.51
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.56
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.53 to 0.69
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.69
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.52 to 0.63
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.53 to 0.66
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.42 to 0.64
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.60
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.88
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.26
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.35
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.28 to 0.43
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Arm/Group Description:	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	216	217
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1, 1 Month Post Vax 2	80; (65.0 to 97.7)	34; (27.2 to 43.7)
Serotype 1, 1 Year Post Vax 2	39; (31.1 to 48.2)	22; (17.4 to 27.6)
Serotype 3, 1 Month Post Vax 2	50; (42.1 to 59.2)	32; (26.1 to 38.9)
Serotype 3, 1 Year Post Vax 2	20; (16.5 to 23.6)	16; (13.2 to 19.1)
Serotype 4, 1 Month Post Vax 2	437; (332.0 to 576.3)	237; (173.5 to 325.1)
Serotype 4, 1 Year Post Vax 2	311; (238.1 to 407.1)	186; (138.3 to 250.2)
Serotype 5, 1 Month Post Vax 2	62; (48.1 to 79.4)	49; (37.4 to 63.7)
Serotype 5, 1 Year Post Vax 2	58; (45.0 to 74.4)	42; (31.7 to 54.8)
Serotype 6A, 1 Month Post Vax 2	1088; (843.2 to 1404.7)	569; (421.8 to 768.5)
Serotype 6A, 1 Year Post Vax 2	257; (192.4 to 342.9)	133; (97.4 to 182.1)
Serotype 6B, 1 Month Post Vax 2	1516; (1173.7 to 1957.5)	781; (574.8 to 1061.9)
Serotype 6B, 1 Year Post Vax 2	561; (421.4 to 746.9)	381; (282.6 to 514.5)
Serotype 7F, 1 Month Post Vax 2	233; (166.5 to 324.8)	135; (93.2 to 194.5)
Serotype 7F, 1 Year Post Vax 2	173; (125.9 to 239.1)	117; (82.8 to 165.4)
Serotype 9V, 1 Month Post Vax 2	166; (113.8 to 241.5)	91; (62.0 to 133.3)
Serotype 9V, 1 Year Post Vax 2	83; (56.2 to 121.9)	73; (49.9 to 105.9)
Serotype 14, 1 Month Post Vax 2	216; (163.8 to 284.3)	199; (146.9 to 270.8)
Serotype 14, 1 Year Post Vax 2	209; (159.5 to 272.9)	244; (184.5 to 321.9)
Serotype 18C, 1 Month Post Vax 2	1015; (832.6 to 1237.6)	523; (395.1 to 693.5)
Serotype 18C, 1 Year Post Vax 2	553; (446.5 to 685.6)	366; (277.2 to 482.9)
Serotype 19A, 1 Month Post Vax 2	356; (297.6 to 425.6)	255; (207.8 to 313.7)
Serotype 19A, 1 Year Post Vax 2	228; (189.1 to 276.1)	182; (147.7 to 225.2)
Serotype 19F, 1 Month Post Vax 2	349; (274.7 to 444.5)	178; (134.1 to 235.0)
Serotype 19F, 1 Year Post Vax 2	274; (214.2 to 350.8)	158; (119.1 to 210.6)
Serotype 23F, 1 Month Post Vax 2	324; (250.8 to 419.8)	113; (82.4 to 154.8)
Serotype 23F, 1 Year Post Vax 2	102; (77.0 to 135.0)	46; (33.9 to 61.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.42 to 0.56
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.56 to 0.72
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.35 to 0.45
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.57
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.85
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.97
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.08
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.74 to 0.99
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.19 to 0.29
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.19 to 0.29
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.45
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.40 to 0.59
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.96
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.13
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.37 to 0.67
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.12
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.09
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.43
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.62
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.59 to 0.83
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.72
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.79
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.93
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.05
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.27 to 0.37
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.48
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

5. Secondary Outcome

Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame	Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)
Arm/Group Description:	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	124	204	173
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1, Pre Vax 2	52; (38.2 to 69.5)	56; (44.4 to 70.6)	44; (33.0 to 57.7)
Serotype 1, 1 Year Post Vax 2	52; (39.6 to 69.0)	50; (39.7 to 63.9)	34; (26.2 to 45.1)
Serotype 3, Pre Vax 2	19; (14.5 to 24.1)	23; (18.6 to 28.1)	26; (20.3 to 32.4)
Serotype 3, 1 Year Post Vax 2	18; (14.2 to 22.3)	26; (21.4 to 31.6)	18; (14.7 to 22.4)
Serotype 4, Pre Vax 2	710; (504.4 to 998.7)	591; (437.9 to 798.0)	350; (242.0 to 506.6)
Serotype 4, 1 Year Post Vax 2	376; (264.2 to 534.0)	414; (312.3 to 548.2)	209; (144.6 to 302.1)
Serotype 5, Pre Vax 2	39; (26.2 to 56.7)	66; (48.9 to 87.8)	49; (36.4 to 67.1)
Serotype 5, 1 Year Post Vax 2	29; (20.4 to 42.1)	73; (55.3 to 96.4)	43; (31.9 to 58.2)
Serotype 6A, Pre Vax 2	540; (347.1 to 838.8)	656; (484.0 to 888.4)	85; (56.3 to 127.7)
Serotype 6A, 1 Year Post Vax 2	331; (227.1 to 483.3)	251; (183.4 to 343.3)	108; (74.7 to 157.3)
Serotype 6B, Pre Vax 2	459; (292.2 to 719.9)	430; (304.8 to 605.6)	192; (128.4 to 286.0)
Serotype 6B, 1 Year Post Vax 2	781; (529.8 to 1150.8)	580; (427.9 to 786.8)	298; (203.8 to 435.6)
Serotype 7F, Pre Vax 2	146; (89.4 to 237.1)	133; (92.4 to 191.0)	71; (46.9 to 107.6)
Serotype 7F, 1 Year Post Vax 2	244; (155.7 to 383.4)	414; (313.8 to 546.5)	146; (99.7 to 212.8)
Serotype 9V, Pre Vax 2	96; (58.3 to 158.4)	79; (53.2 to 116.2)	50; (32.4 to 78.5)
Serotype 9V, 1 Year Post Vax 2	201; (125.8 to 320.2)	212; (147.4 to 306.4)	147; (95.8 to 226.8)
Serotype 14, Pre Vax 2	241; (159.6 to 364.0)	290; (208.6 to 403.1)	302; (214.2 to 425.3)
Serotype 14, 1 Year Post Vax 2	383; (274.1 to 534.2)	420; (317.0 to 556.1)	367; (272.9 to 493.4)
Serotype 18C, Pre Vax 2	403; (273.8 to 592.0)	462; (346.1 to 615.8)	339; (236.2 to 487.4)
Serotype 18C, 1 Year Post Vax 2	398; (274.1 to 579.1)	513; (389.5 to 676.1)	349; (247.8 to 492.2)
Serotype 19A, Pre Vax 2	203; (151.3 to 271.8)	209; (170.3 to 257.6)	153; (117.3 to 199.5)
Serotype 19A, 1 Year Post Vax 2	253; (197.2 to 325.7)	296; (248.3 to 353.0)	169; (133.0 to 214.6)
Serotype 19F, Pre Vax 2	114; (72.7 to 177.5)	183; (135.0 to 247.7)	127; (89.7 to 180.1)
Serotype 19F, 1 Year Post Vax 2	238; (165.2 to 341.7)	419; (334.2 to 524.2)	190; (139.8 to 258.7)
Serotype 23F, Pre Vax 2	90; (58.5 to 139.9)	90; (65.4 to 123.6)	30; (21.2 to 42.1)
Serotype 23F, 1 Year Post Vax 2	104; (67.9 to 158.6)	66; (48.7 to 88.9)	36; (26.3 to 50.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.22
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.02
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.90
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.10
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.32
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.81
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.69
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.82
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.47 to 0.76
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.87
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.30
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.02
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.79
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.46
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.75
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.32 to 2.19
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 1.14 to 1.60
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 1.20 to 2.01
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.24 to 2.26
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; 2.26 to 4.30
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; 1.53 to 2.75
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 1.48 to 2.95
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 1.97 to 3.70
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 1.99 to 4.29
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 1.23 to 2.05
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 1.18 to 1.78
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 1.04 to 1.42
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.19
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.29
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.20
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 1.07 to 1.46
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 1.24 to 1.61
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.27
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rises
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 1.56 to 2.80
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 1.82 to 2.88
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.18 to 1.90
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.48
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.85
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.51
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

6. Secondary Outcome

Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame	Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
Arm/Group Description:	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	217	219
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1, Pre Vax 2	33; (26.4 to 41.1)	21; (17.1 to 26.9)
Serotype 1, 1 Year Post Vax 2	38; (30.7 to 47.5)	22; (17.5 to 27.8)
Serotype 3, Pre Vax 2	16; (13.2 to 19.4)	16; (13.0 to 19.4)
Serotype 3, 1 Year Post Vax 2	19; (16.2 to 23.2)	16; (13.3 to 19.4)
Serotype 4, Pre Vax 2	129; (89.0 to 186.9)	73; (50.4 to 104.7)
Serotype 4, 1 Year Post Vax 2	267; (198.8 to 358.8)	177; (129.9 to 240.0)
Serotype 5, Pre Vax 2	32; (25.0 to 41.4)	24; (18.0 to 30.8)
Serotype 5, 1 Year Post Vax 2	57; (44.5 to 73.2)	42; (32.2 to 55.6)
Serotype 6A, Pre Vax 2	279; (203.4 to 383.4)	58; (41.9 to 81.1)
Serotype 6A, 1 Year Post Vax 2	256; (191.2 to 341.9)	113; (82.5 to 155.2)
Serotype 6B, Pre Vax 2	403; (290.6 to 558.3)	186; (131.1 to 264.3)
Serotype 6B, 1 Year Post Vax 2	511; (376.9 to 693.4)	361; (263.4 to 495.7)
Serotype 7F, Pre Vax 2	66; (46.3 to 95.3)	66; (45.5 to 95.0)
Serotype 7F, 1 Year Post Vax 2	175; (127.1 to 240.3)	111; (78.4 to 157.4)
Serotype 9V, Pre Vax 2	40; (27.6 to 59.1)	28; (19.7 to 40.6)
Serotype 9V, 1 Year Post Vax 2	76; (51.6 to 112.9)	69; (47.3 to 100.9)
Serotype 14, Pre Vax 2	130; (96.1 to 176.2)	144; (104.7 to 198.7)
Serotype 14, 1 Year Post Vax 2	204; (155.6 to 268.5)	240; (180.7 to 319.3)
Serotype 18C, Pre Vax 2	436; (340.9 to 556.7)	271; (197.8 to 371.7)
Serotype 18C, 1 Year Post Vax 2	545; (438.2 to 678.0)	360; (272.5 to 475.9)
Serotype 19A, Pre Vax 2	185; (152.8 to 222.9)	124; (97.4 to 158.3)
Serotype 19A, 1 Year Post Vax 2	235; (196.4 to 282.2)	181; (146.7 to 223.8)
Serotype 19F, Pre Vax 2	121; (91.1 to 160.0)	84; (61.6 to 115.4)
Serotype 19F, 1 Year Post Vax 2	261; (204.9 to 333.7)	159; (119.0 to 211.4)
Serotype 23F, Pre Vax 2	60; (44.5 to 81.1)	30; (22.3 to 41.0)
Serotype 23F, 1 Year Post Vax 2	104; (78.0 to 137.4)	46; (33.9 to 61.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 1.03 to 1.31
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.16
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 1.07 to 1.37
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.13
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 1.60 to 2.68
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.82 to 3.24
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 1.55 to 2.03
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 1.54 to 2.09
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.07
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 1.48 to 2.55
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.53
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 1.50 to 2.51
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 1.98 to 3.50
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.31 to 2.18
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 1.37 to 2.61
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.76 to 3.38
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 1.33 to 1.86
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.38 to 2.01
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 1.10 to 1.42
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 1.14 to 1.55
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 1.14 to 1.43
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.28 to 1.67
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 1.80 to 2.60
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 1.53 to 2.31
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.44 to 2.06
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.24 to 1.84
	Estimation Comments	Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.

7. Secondary Outcome

Title	Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)
Description	Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Time Frame	Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)

Outcome Measure Data

Analysis Population Description

All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.

Arm/Group Title	13vPnC/13vPnC Group (23vPS Naïve)	13vPnC/23vPS Group (23vPS Naïve)	23vPS/13vPnC Group (23vPS Naïve)
Arm/Group Description:	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)	Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
Overall Number of Participants Analyzed	127	199	171
Geometric Mean (95% Confidence Interval); Unit of Measure: titer
Serotype 1, 1 Month Post Vax 1	229; (176.7 to 295.9)	228; (185.8 to 280.7)	147; (112.6 to 192.0)
Serotype 1, 1 Year Post Vax 2	54; (40.6 to 71.4)	47; (37.5 to 60.0)	35; (26.6 to 46.3)
Serotype 3, 1 Month Post Vax 1	75; (59.1 to 95.5)	75; (61.6 to 91.6)	85; (69.0 to 103.9)
Serotype 3, 1 Year Post Vax 2	19; (14.8 to 23.3)	27; (22.5 to 32.8)	18; (14.8 to 22.5)
Serotype 4, 1 Month Post Vax 1	2546; (1908.6 to 3395.8)	2575; (2075.2 to 3195.9)	1406; (1026.6 to 1926.5)
Serotype 4, 1 Year Post Vax 2	346; (242.6 to 493.7)	405; (304.4 to 538.3)	184; (127.1 to 267.4)
Serotype 5, 1 Month Post Vax 1	153; (101.6 to 229.5)	255; (190.1 to 341.4)	145; (106.8 to 197.9)
Serotype 5, 1 Year Post Vax 2	26; (18.5 to 37.8)	69; (52.4 to 91.8)	45; (33.6 to 61.0)
Serotype 6A, 1 Month Post Vax 1	2757; (2027.3 to 3750.3)	3022; (2356.7 to 3875.6)	335; (227.3 to 494.8)
Serotype 6A, 1 Year Post Vax 2	286; (195.1 to 418.1)	235; (171.4 to 320.9)	105; (73.1 to 152.2)
Serotype 6B, 1 Month Post Vax 1	1739; (1176.0 to 2570.2)	1969; (1512.1 to 2562.7)	767; (545.3 to 1080.0)
Serotype 6B, 1 Year Post Vax 2	855; (595.2 to 1227.5)	697; (523.9 to 926.4)	319; (220.5 to 462.1)
Serotype 7F, 1 Month Post Vax 1	906; (590.6 to 1388.7)	1459; (1147.2 to 1855.1)	365; (243.8 to 546.8)
Serotype 7F, 1 Year Post Vax 2	231; (148.8 to 359.6)	398; (301.1 to 527.0)	143; (97.9 to 208.2)
Serotype 9V, 1 Month Post Vax 1	1055; (740.6 to 1502.7)	801; (589.0 to 1090.0)	294; (192.2 to 449.9)
Serotype 9V, 1 Year Post Vax 2	203; (127.4 to 322.0)	224; (155.1 to 322.3)	127; (82.5 to 196.0)
Serotype 14, 1 Month Post Vax 1	614; (409.0 to 921.9)	727; (527.6 to 1000.7)	748; (535.4 to 1045.9)
Serotype 14, 1 Year Post Vax 2	387; (277.1 to 540.7)	435; (329.4 to 575.6)	391; (291.9 to 524.8)
Serotype 18C, 1 Month Post Vax 1	1603; (1153.7 to 2226.2)	1614; (1230.2 to 2117.7)	888; (639.0 to 1233.2)
Serotype 18C, 1 Year Post Vax 2	409; (281.0 to 596.0)	560; (424.2 to 739.8)	323; (227.9 to 457.0)
Serotype 19A, 1 Month Post Vax 1	698; (522.4 to 932.2)	781; (662.0 to 920.4)	380; (296.6 to 486.6)
Serotype 19A, 1 Year Post Vax 2	243; (185.7 to 319.1)	310; (260.8 to 369.0)	162; (126.7 to 207.7)
Serotype 19F, 1 Month Post Vax 1	530; (361.7 to 775.7)	845; (661.8 to 1079.9)	423; (302.2 to 591.4)
Serotype 19F, 1 Year Post Vax 2	239; (166.7 to 342.6)	416; (333.0 to 519.7)	180; (131.7 to 245.7)
Serotype 23F, 1 Month Post Vax 1	339; (219.9 to 521.8)	367; (268.3 to 501.2)	72; (49.1 to 104.7)
Serotype 23F, 1 Year Post Vax 2	105; (69.5 to 159.3)	70; (52.0 to 95.0)	39; (27.6 to 53.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.19 to 0.29
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.25
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.20 to 0.29
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.20 to 0.30
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.42
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.26
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.18
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.12 to 0.20
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; 0.10 to 0.18
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; 0.13 to 0.22
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC/23vPS Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.33
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	23vPS/13vPnC Group (23vPS Naïve)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; 0.25 to 0.38
	Estimation Comments	CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC/13vPnC Group (23vPS Naïve)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Geometric mean fold rise