Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00500357

Collaborator

(none)

105

Enrollment

Locations

Duration (Months)

6.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.

Condition or Disease	Intervention/Treatment	Phase
Vaccines, Pneumococcal Conjugate Vaccine	Biological: 13-valent Pneumococcal Conjugate Vaccine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) [Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)]
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Secondary Outcome Measures

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) [Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)]
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1) [Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)]
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2) [Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)]
Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Other Outcome Measures

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) [Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)]
Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3) [Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)]
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
Generally healthy male or female adults 65 years of age or older
Available for the duration of the trial - approximately 1 month
No history of severe adverse reaction associated with a vaccine
MMSE score less than or equal to 21 was an exclusion criteria.

Contacts and Locations

Locations

	City	Country	Postal Code
1	Amanzimtoti	South Africa	4126
2	Bishop Lavis	South Africa	7490
3	Bloemfontein	South Africa	9317
4	Brits	South Africa	0250
5	Cape Town	South Africa	7941
6	Cape Town	South Africa	7945
7	Lenasia	South Africa	1827
8	Paarl	South Africa	7646
9	Parow	South Africa	7500
10	Parys	South Africa	9585
11	Pretoria	South Africa	0002
12	Pretoria	South Africa	0082
13	Pretoria	South Africa	0083
14	Pretoria	South Africa	0183
15	Scottburgh South	South Africa	4180
16	Vanderbijlpark	South Africa	1911

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00500357

Other Study ID Numbers:

6115A1-3009

First Posted:

Jul 12, 2007

Last Update Posted:

Apr 19, 2011

Last Verified:

Apr 1, 2011

Additional relevant MeSH terms:

Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 [Vax 1]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).
Pre-assignment Detail	105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).

Arm/Group Title	13vPnC (Vax 3 Follow-up / NCT00500357)
Arm/Group Description	Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Period Title: Overall Study
STARTED	105
Received 13vPnC (Vax 3)	105
Evaluable Immunogenicity Population	98
COMPLETED	104
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	13vPnC (Vax 3 Follow-up / NCT00500357)
Arm/Group Description	Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Overall Participants	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.8 (4.9)
Sex: Female, Male (Count of Participants)
Female	56 53.3%
Male	49 46.7%

Outcome Measures

1. Primary Outcome

Title	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Description	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame	Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.

Arm/Group Title	13vPnC (Vax 1 Core Study/NCT00269672)	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
Arm/Group Description	13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	96	96
Serotype 1	198	78
Serotype 3	126	104
Serotype 4	2210	1254
Serotype 5	413	170
Serotype 6A	4931	3158
Serotype 6B	3251	2440
Serotype 7F	869	353
Serotype 9V	977	247
Serotype 14	982	550
Serotype 18C	2860	1457
Serotype 19A	1141	431
Serotype 19F	1014	494
Serotype 23F	523	661

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.28 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus [-] Vax 1).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95% 0.67 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95% 0.44 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.32 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95% 0.45 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95% 0.56 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.25 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95% 0.16 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95% 0.40 to 0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95% 0.40 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.30 to 0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.5
	Confidence Interval	(2-Sided) 95% 0.35 to 0.67
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95% 0.86 to 1.86
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).

2. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Description	Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).
Time Frame	Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.

Arm/Group Title	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)
Arm/Group Description	Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	91
Redness: Any (n=79)	7.6 7.2%
Redness: Mild (n=79)	6.3 6%
Redness: Moderate (n=78)	3.8 3.6%
Redness: Severe (n=78)	0.0 0%
Swelling: Any (n=83)	16.9 16.1%
Swelling: Mild (n=81)	12.3 11.7%
Swelling: Moderate (n=81)	8.6 8.2%
Swelling: Severe (n=78)	0.0 0%
Pain: Any (n=89)	40.4 38.5%
Pain: Mild (n=88)	34.1 32.5%
Pain: Moderate (n=83)	15.7 15%
Pain: Severe (n=78)	0.0 0%
Limitation of arm movement: Any (n=80)	11.3 10.8%
Limitation of arm movement: Mild (n=80)	8.8 8.4%
Limitation of arm movement: Moderate (n=78)	2.6 2.5%
Limitation of arm movement: Severe (n=79)	1.3 1.2%

3. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)
Description	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.
Time Frame	Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.

Arm/Group Title	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)
Arm/Group Description	Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	91
Fever: Any ≥38 degrees C (n=81)	7.4 7%
Fever: Mild ≥38 but <38.5 degrees C (n=80)	3.8 3.6%
Fever: Moderate ≥38.5 but <39 degrees C (n=78)	2.6 2.5%
Fever: Severe ≥39 but ≤40 degrees C (n=80)	2.5 2.4%
Potentially life-threatening >40 degrees C (n=79)	1.3 1.2%
Fatigue (n=83)	27.7 26.4%
Headache (n=81)	19.8 18.9%
Chills (n=79)	8.9 8.5%
Rash (n=78)	2.6 2.5%
Vomiting (n=79)	1.3 1.2%
Decreased appetite (n=82)	18.3 17.4%
New muscle pain (n=84)	21.4 20.4%
Aggravated muscle pain (n=80)	12.5 11.9%
New joint pain (n=78)	7.7 7.3%
Aggravated joint pain (n=79)	6.3 6%

4. Secondary Outcome

Title	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Description	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame	Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.

Arm/Group Title	13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
Arm/Group Description	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	97	97
Serotype 1	184	81
Serotype 3	131	104
Serotype 4	1457	1406
Serotype 5	326	219
Serotype 6A	1732	3443
Serotype 6B	1862	2505
Serotype 7F	1292	351
Serotype 9V	624	267
Serotype 14	808	557
Serotype 18C	1753	1452
Serotype 19A	756	511
Serotype 19F	901	527
Serotype 23F	484	731

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.34 to 0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95% 0.66 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95% 0.76 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95% 0.57 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95% 1.39 to 2.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95% 1.11 to 1.63
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95% 0.18 to 0.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% 0.27 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95% 0.57 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95% 0.66 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95% 0.58 to 0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95% 0.47 to 0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95% 1.18 to 1.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

5. Secondary Outcome

Title	Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)
Description	Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs 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 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.

Arm/Group Title	13vPnC (Vax 1 Core Study/NCT00269672)	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
Arm/Group Description	13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	98	98
Serotype 1	7.67	4.99
Serotype 3	2.60	1.35
Serotype 4	4.68	2.96
Serotype 5	19.51	6.33
Serotype 6A	9.12	8.22
Serotype 6B	13.03	10.32
Serotype 7F	6.93	5.02
Serotype 9V	11.56	5.77
Serotype 14	17.51	13.34
Serotype 18C	20.59	7.82
Serotype 19A	29.52	17.80
Serotype 19F	13.39	8.55
Serotype 23F	10.16	7.73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95% 0.52 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 95% 0.43 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95% 0.53 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95% 0.27 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.74 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.63 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95% 0.60 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95% 0.42 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.59 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95% 0.31 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95% 0.49 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95% 0.52 to 0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.62 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).

6. Secondary Outcome

Title	Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)
Description	Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs 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 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Outcome Measure Data

Analysis Population Description
Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.

Arm/Group Title	13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
Arm/Group Description	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).	13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
Measure Participants	98	98
Serotype 1	7.29	4.99
Serotype 3	2.46	1.36
Serotype 4	3.93	2.96
Serotype 5	9.29	6.33
Serotype 6A	5.51	8.22
Serotype 6B	9.67	10.32
Serotype 7F	7.41	5.02
Serotype 9V	9.60	5.77
Serotype 14	22.67	13.34
Serotype 18C	11.66	7.82
Serotype 19A	22.78	17.80
Serotype 19F	15.82	8.55
Serotype 23F	7.27	7.73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.60 to 0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95% 0.48 to 0.64
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95% 0.65 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.61 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.49
	Confidence Interval	(2-Sided) 95% 1.27 to 1.75
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95% 0.94 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.58 to 0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95% 0.53 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95% 0.51 to 0.67
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95% 0.60 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95% 0.69 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95% 0.47 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC (Vax 1 Core Study/NCT00269672), 13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)
	Comments	Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	geometric mean fold rise
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95% 0.90 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).

Adverse Events

	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)		13vPnC+AlPO4 (After Vax 1 Core Study)		13vPnC-AlPO4 (After Vax 1 Core Study)		23vPS (After Vax 1 Core Study)		13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)		13vPnC+AlPO4/23vPS (After Vax 2 Core Study)		13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
Time Frame	Baseline / Day 1 up to 43 days postvaccination. Local Reactions and Systemic Events assessed within 14 days of vaccination.
Adverse Event Reporting Description	An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Arm/Group Title	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)		13vPnC+AlPO4 (After Vax 1 Core Study)		13vPnC-AlPO4 (After Vax 1 Core Study)		23vPS (After Vax 1 Core Study)		13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)		13vPnC+AlPO4/23vPS (After Vax 2 Core Study)		13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
Arm/Group Description	Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009). For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46.		Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.		Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.		Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.		Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.		Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.		Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)		13vPnC+AlPO4 (After Vax 1 Core Study)		13vPnC-AlPO4 (After Vax 1 Core Study)		23vPS (After Vax 1 Core Study)		13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)		13vPnC+AlPO4/23vPS (After Vax 2 Core Study)		13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/105 (1.9%)		2/308 (0.6%)		4/304 (1.3%)		1/302 (0.3%)		3/139 (2.2%)		1/128 (0.8%)		1/273 (0.4%)
Cardiac disorders
Cardio-respiratory arrest	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Bradycardia	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Myocardial ischaemia	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Angina unstable	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Myocardial infarction	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Congenital, familial and genetic disorders
Phimosis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Hepatobiliary disorders
Cholelithiasis	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Injury, poisoning and procedural complications
Hip fracture	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Exostosis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Spinal osteoarthritis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Arthralgia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Intervertebral disc disorder	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Nervous system disorders
Hydrocephalus	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Vascular disorders
Hypertension	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)		13vPnC+AlPO4 (After Vax 1 Core Study)		13vPnC-AlPO4 (After Vax 1 Core Study)		23vPS (After Vax 1 Core Study)		13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)		13vPnC+AlPO4/23vPS (After Vax 2 Core Study)		13vPnC-AlPO4/23vPS (After Vax 2 Core Study)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/105 (43.8%)		70/308 (22.7%)		58/304 (19.1%)		80/302 (26.5%)		26/139 (18.7%)		35/128 (27.3%)		76/273 (27.8%)
Blood and lymphatic system disorders
Lymphadenitis	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Cardiac disorders
Cardiac failure congestive	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Angina pectoris	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Palpitations	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Ear and labyrinth disorders
Vertigo	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		1/302 (0.3%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Endocrine disorders
Hypothyroidism	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Eye disorders
Conjunctivitis	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Dacryoadenitis acquired	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Eye pain	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Gastrointestinal disorders
Vomiting	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		3/302 (1%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Abdominal pain upper	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Diarrhoea	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		1/302 (0.3%)		1/139 (0.7%)		1/128 (0.8%)		2/273 (0.7%)
Toothache	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Hiatus hernia	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Anal haemorrhage	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Anal polyp	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Enterocolitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Erosive oesophagitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Melaena	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Abdominal discomfort	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Abdominal pain	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Dyspepsia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
General disorders
Fatigue	2/105 (1.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever (any) ≥ 38 degrees Celsius (C)	6/81 (7.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever (mild) ≥ 38 but <38.5 degrees C	3/80 (3.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever (moderate) ≥ 38.5 but <39 degrees C	2/78 (2.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever (severe) ≥ 39 but ≤40 degrees C	2/80 (2.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever (potentially life-threatening) >40 degrees C	1/79 (1.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fatigue	23/83 (27.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Headache	16/81 (19.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Chills	7/79 (8.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rash	2/78 (2.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Vomiting	1/79 (1.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetitie	15/82 (18.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
New muscle pain	18/84 (21.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Aggravated muscle pain	10/80 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
New joint pain	6/78 (7.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Aggravated joint pain	5/79 (6.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fatigue	0/0 (NaN)		9/308 (2.9%)		17/304 (5.6%)		22/302 (7.3%)		5/139 (3.6%)		8/128 (6.3%)		17/273 (6.2%)
Injection site pain	0/0 (NaN)		6/308 (1.9%)		9/304 (3%)		9/302 (3%)		6/139 (4.3%)		8/128 (6.3%)		18/273 (6.6%)
Injection site movement impairment	0/0 (NaN)		6/308 (1.9%)		6/304 (2%)		6/302 (2%)		1/139 (0.7%)		4/128 (3.1%)		12/273 (4.4%)
Injection site erythema	0/0 (NaN)		9/308 (2.9%)		3/304 (1%)		6/302 (2%)		2/139 (1.4%)		7/128 (5.5%)		20/273 (7.3%)
Injection site swelling	0/0 (NaN)		6/308 (1.9%)		4/304 (1.3%)		3/302 (1%)		1/139 (0.7%)		9/128 (7%)		19/273 (7%)
Pyrexia	0/0 (NaN)		0/308 (0%)		2/304 (0.7%)		2/302 (0.7%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Chills	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		1/302 (0.3%)		1/139 (0.7%)		0/128 (0%)		1/273 (0.4%)
Injection site inflammation	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Injection site joint movement impairment	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Malaise	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Asthenia	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Chest pain	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Injection site induration	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Injection site pruritus	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Injection site rash	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Hepatobiliary disorders
Cholecystitis	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Cholelithiasis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Immune system disorders
Drug hypersensitivity	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hypersensitivity	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Infections and infestations
Gastroenteritis	2/105 (1.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Cystitis	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Viral rhinitis	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pharyngitis	0/0 (NaN)		2/308 (0.6%)		3/304 (1%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Influenza	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		3/302 (1%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Gastroenteritis	0/0 (NaN)		3/308 (1%)		0/304 (0%)		2/302 (0.7%)		1/139 (0.7%)		1/128 (0.8%)		4/273 (1.5%)
Nasopharyngitis	0/0 (NaN)		0/308 (0%)		2/304 (0.7%)		2/302 (0.7%)		1/139 (0.7%)		0/128 (0%)		1/273 (0.4%)
Bronchitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		4/302 (1.3%)		1/139 (0.7%)		0/128 (0%)		2/273 (0.7%)
Sinusitis	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		1/302 (0.3%)		1/139 (0.7%)		1/128 (0.8%)		1/273 (0.4%)
Rhinitis	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		2/302 (0.7%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Upper respiratory tract infection	0/0 (NaN)		0/308 (0%)		0/304 (0%)		3/302 (1%)		0/139 (0%)		1/128 (0.8%)		3/273 (1.1%)
Cellulitis	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Urinary tract infection	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		2/128 (1.6%)		1/273 (0.4%)
Cystitis	0/0 (NaN)		2/308 (0.6%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Herpes simplex	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Tinea infection	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Tooth abscess	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Herpes zoster	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Respiratory tract infection	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Parotitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Viral pharyngitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Viral rhinitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Lower respiratory tract infection	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Viral upper respiratory tract infection	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Injury, poisoning and procedural complications
Arthropod bite	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Injury	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Joint injury	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Joint sprain	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Meniscus lesion	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Muscle strain	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Road traffic accident	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Animal bite	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Limb injury	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Muscle injury	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Pelvic fracture	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Skeletal injury	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Skin laceration	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Stress fracture	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Investigations
Body temperature increased	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/0 (NaN)		6/308 (1.9%)		5/304 (1.6%)		3/302 (1%)		2/139 (1.4%)		2/128 (1.6%)		3/273 (1.1%)
Gout	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Diabetes mellitus inadequate control	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Hypercholesterolaemia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Hypokalaemia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Arthralgia	0/0 (NaN)		8/308 (2.6%)		7/304 (2.3%)		9/302 (3%)		3/139 (2.2%)		1/128 (0.8%)		3/273 (1.1%)
Myalgia	0/0 (NaN)		6/308 (1.9%)		7/304 (2.3%)		10/302 (3.3%)		4/139 (2.9%)		7/128 (5.5%)		9/273 (3.3%)
Muscle spasms	0/0 (NaN)		2/308 (0.6%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Osteoarthritis	0/0 (NaN)		1/308 (0.3%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		1/273 (0.4%)
Joint swelling	0/0 (NaN)		0/308 (0%)		2/304 (0.7%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Arthritis	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		1/273 (0.4%)
Back pain	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Joint range of motion decreased	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Rotator cuff syndrome	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Monarthritis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Tendonitis	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Musculoskeletal chest pain	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Nervous system disorders
Headache	1/105 (1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Headache	0/0 (NaN)		11/308 (3.6%)		17/304 (5.6%)		16/302 (5.3%)		6/139 (4.3%)		9/128 (7%)		12/273 (4.4%)
Dizziness	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Migraine	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Neuralgia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Psychiatric disorders
Anxiety	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Insomnia	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Renal and urinary disorders
Urinary retention	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Rhinorrhoea	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Cough	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		1/139 (0.7%)		1/128 (0.8%)		1/273 (0.4%)
Oropharyngeal pain	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Rhinitis allergic	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Dry throat	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Pleurisy	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Sneezing	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		1/128 (0.8%)		0/273 (0%)
Skin and subcutaneous tissue disorders
Redness (any)	6/79 (7.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Redness (mild)	5/79 (6.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Redness (moderate)	3/78 (3.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Redness (severe)	0/78 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling (any)	14/83 (16.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling (mild)	10/81 (12.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling (moderate)	7/81 (8.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Swelling (severe)	0/78 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain (any)	36/89 (40.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain (mild)	30/88 (34.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain (moderate)	13/83 (15.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Pain (severe)	0/78 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Limitation of arm movement (any)	9/80 (11.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Limitation of arm movement (mild)	7/80 (8.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Limitation of arm movement (moderate)	2/78 (2.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Limitation of arm movement (severe)	1/79 (1.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Rash	0/0 (NaN)		0/308 (0%)		2/304 (0.7%)		3/302 (1%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Hyperkeratosis	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Lentigo	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Rash macular	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Erythema	0/0 (NaN)		0/308 (0%)		1/304 (0.3%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		0/273 (0%)
Dermatitis contact	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		2/273 (0.7%)
Rash maculo-papular	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Rash vesicular	0/0 (NaN)		0/308 (0%)		0/304 (0%)		0/302 (0%)		0/139 (0%)		0/128 (0%)		1/273 (0.4%)
Vascular disorders
Thrombophlebitis	0/0 (NaN)		1/308 (0.3%)		0/304 (0%)		0/302 (0%)		1/139 (0.7%)		0/128 (0%)		0/273 (0%)
Hypertension	0/0 (NaN)		0/308 (0%)		0/304 (0%)		1/302 (0.3%)		0/139 (0%)		0/128 (0%)		0/273 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.govCallCenter@pfizer.com

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00500357

Other Study ID Numbers:

6115A1-3009

First Posted:

Jul 12, 2007

Last Update Posted:

Apr 19, 2011

Last Verified:

Apr 1, 2011