Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574548

Enrollment

720

Registered

2007-12-17

Start date

2007-11-30

Completion date

2010-02-28

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Vaccines

Keywords

Vaccines, Pneumococcal Conjugate Vaccine

Brief summary

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Interventions

BIOLOGICAL13 valent Pneumococcal Conjugate Vaccine

0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1

BIOLOGICAL23-valent Pneumococcal Polysaccharide Vaccine

0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or Female, aged 60 to 64 years. * Healthy.

Exclusion criteria

* Previous vaccination with any licensed or experimental pneumococcal vaccine. * History of severe adverse reaction associated with a vaccine. * Immunodeficiency.

Design outcomes

Primary

Measure	Time frame	Description
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 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 OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 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

Measure	Time frame	Description
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. 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 OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 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.

Other

Measure	Time frame	Description
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 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.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).

Countries

United States

Participant flow

Participants by arm

Arm	Count
13vPnC - Group 1.1 or 1.2 Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.	478
23vPS - Group 2 Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.	237
Total	715

Baseline characteristics

Characteristic	13vPnC - Group 1.1 or 1.2	23vPS - Group 2	Total
Age Continuous	61.7 years STANDARD_DEVIATION 1.4	61.7 years STANDARD_DEVIATION 1.4	61.7 years STANDARD_DEVIATION 1.4
Sex: Female, Male Female	281 Participants	134 Participants	415 Participants
Sex: Female, Male Male	197 Participants	103 Participants	300 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	256 / 478	102 / 237	41 / 478	24 / 237	97 / 160	198 / 267	118 / 223	16 / 160	23 / 267	16 / 223
serious Total, serious adverse events	2 / 478	1 / 237	15 / 478	6 / 237	0 / 160	2 / 267	1 / 223	5 / 160	6 / 267	3 / 223

Outcome results

Primary

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)

Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 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: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 1	148 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 3	125 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 4	1385 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 5	199 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 6B	1215 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 7F	537 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 9V	373 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 14	622 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 18C	1062 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 19A	467 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 19F	774 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 23F	198 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 19F	286 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 1	77 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 9V	114 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 3	50 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 19A	289 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 4	935 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 14	435 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 5	85 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 23F	124 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 6B	710 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 18C	564 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Common Serotype 7F	126 geometric mean titer

Comparison: Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.43, 2.57]

Comparison: Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.95, 3.16]

Comparison: Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.12, 1.96]

Comparison: Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.67, 3.31]

Comparison: Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.19, 2.47]

Comparison: Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.76, 6.61]

Comparison: Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.97, 5.45]

Comparison: Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.98, 2.1]

Comparison: Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.32, 2.69]

Comparison: Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.27, 2.07]

Comparison: Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.96, 3.74]

Comparison: Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.05, 2.45]

Primary

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)

Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 1	148 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 3	125 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 4	1385 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 5	199 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 6B	1215 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 7F	537 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 9V	373 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 14	622 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 18C	1062 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 19A	467 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 19F	774 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 23F	198 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 19F	509 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 1	148 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 9V	288 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 3	80 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 19A	376 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 4	1357 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 14	734 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 5	140 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 23F	70 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 6B	706 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 18C	789 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Common Serotype 7F	331 geometric mean titer

Comparison: Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.75, 1.33]

Comparison: Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.24, 1.94]

Comparison: Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.74, 1.41]

Comparison: Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.01, 2]

Comparison: Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.18, 2.51]

Comparison: Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.07, 2.47]

Comparison: Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.79, 2.12]

Comparison: Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.58, 1.25]

Comparison: Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.94, 1.93]

Comparison: Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [0.96, 1.61]

Comparison: Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.09, 2.12]

Comparison: Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.86, 4.35]

Secondary

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)

Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	220 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	74 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	2517 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	227 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	2012 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	1252 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	758 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	664 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	1532 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	696 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	696 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	358 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	773 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	140 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	406 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	129 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	457 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	1430 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	616 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	188 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	216 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	1351 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	1074 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	533 geometric mean titer

Comparison: Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.55, 0.75]

Comparison: Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [1.52, 2.01]

Comparison: Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.49, 0.66]

Comparison: Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.67, 1.03]

Comparison: Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.57, 0.79]

Comparison: Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.35, 0.52]

Comparison: Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.41, 0.69]

Comparison: Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.75, 1.15]

Comparison: Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.58, 0.85]

Comparison: Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.58, 0.74]

Comparison: Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.89, 1.39]

Comparison: Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.5, 0.73]

Secondary

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)

Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. 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: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	2255 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	919 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Additional Serotype 6A	2682 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	492 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	73 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	1440 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	2112 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	583 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	170 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	566 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	930 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	291 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	215 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	456 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	142 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	89 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	1214 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	98 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Additional Serotype 6A	2281 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	1882 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	323 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	335 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	384 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	986 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	385 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	502 geometric mean titer

Comparison: Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.54, 0.82]

Comparison: Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.99, 1.49]

Comparison: Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.43, 0.68]

Comparison: Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.43, 0.77]

Comparison: Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.67, 1.08]

Comparison: Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.71, 1.12]

Comparison: Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.24, 0.49]

Comparison: Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.26, 0.51]

Comparison: Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.6, 1.02]

Comparison: Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.54, 0.87]

Comparison: Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.53, 0.82]

Comparison: Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [0.69, 1.15]

Comparison: Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.95% CI: [1.15, 2.13]

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)

Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Any (n=61, 61)	14.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Mild (n=57, 57)	7.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Moderate (n=58, 58)	8.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Severe (n=57, 57)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Any (n=60, 60)	10.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Mild (n=59, 59)	6.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Moderate (n=55, 55)	1.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Severe (n=56, 56)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Any (n=108, 108)	76.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Mild (n=101, 101)	72.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Moderate (n=61, 61)	21.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Severe (n=57, 57)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Any (n=65, 65)	26.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Mild (n=65, 65)	26.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Moderate (n=56, 56)	1.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Severe (n=56, 56)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Severe (n=56, 56)	1.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Any (n=61, 61)	11.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Any (n=108, 108)	75.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Mild (n=57, 57)	8.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Any (n=65, 65)	24.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Moderate (n=58, 58)	3.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Mild (n=101, 101)	72.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Redness: Severe (n=57, 57)	3.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Moderate (n=56, 56)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Any (n=60, 60)	11.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Moderate (n=61, 61)	26.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Mild (n=59, 59)	8.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Limitation of arm movement: Mild (n=65, 65)	24.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Moderate (n=55, 55)	3.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Pain: Severe (n=57, 57)	3.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Swelling: Severe (n=56, 56)	1.8 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Any (n=270, 115)	12.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Mild (n=266, 115)	8.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Moderate (n=264, 115)	6.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Severe (n=259, 115)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Any (n=270, 119)	10.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Moderate (n=284, 129)	20.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Mild (n=268, 119)	8.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Moderate (n=263, 116)	3.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Severe (n=258, 115)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Any (n=370, 169)	69.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Mild (n=360, 166)	66.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Severe (n=261, 116)	2.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Any (n=289, 130)	23.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Mild (n=286, 130)	22.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Moderate (n=260, 115)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Severe (n=261, 115)	1.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Severe (n=261, 115)	1.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Any (n=270, 115)	4.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Severe (n=258, 115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Mild (n=266, 115)	4.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Any (n=289, 130)	18.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Moderate (n=264, 115)	0.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Any (n=370, 169)	69.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Redness: Severe (n=259, 115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Moderate (n=260, 115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Mild (n=360, 166)	68.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Moderate (n=284, 129)	17.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Any (n=270, 119)	5.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Limitation of arm movement: Mild (n=286, 130)	16.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Mild (n=268, 119)	5.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Pain: Severe (n=261, 116)	0.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Swelling: Moderate (n=263, 116)	0.9 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Any (n=270, 134)	12.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Mild (n=266, 134)	8.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Moderate (n=264, 128)	6.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Severe (n=259, 127)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Any (n=270, 135)	10.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Mild (n=268, 132)	8.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Moderate (n=263, 132)	3.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Severe (n=258, 127)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Any (n=370, 175)	69.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Mild (n=360, 170)	66.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Moderate (n=284, 143)	20.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Severe (n=261, 127)	2.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Any (n=289, 142)	23.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Mild (n=286, 142)	22.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Moderate (n=260, 127)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Severe (n=261, 128)	1.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Severe (n=261, 128)	2.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Any (n=270, 134)	11.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Any (n=370, 175)	58.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Mild (n=266, 134)	9.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Any (n=289, 142)	28.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Moderate (n=264, 128)	3.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Mild (n=360, 170)	52.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Redness: Severe (n=259, 127)	0.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Moderate (n=260, 127)	3.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Any (n=270, 135)	10.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Moderate (n=284, 143)	21.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Mild (n=268, 132)	6.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Limitation of arm movement: Mild (n=286, 142)	26.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Moderate (n=263, 132)	7.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Pain: Severe (n=261, 127)	0.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Swelling: Severe (n=258, 127)	0.0 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)

Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Any (n=134, 151)	11.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Mild (n=134, 144)	9.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Moderate (n=128, 138)	3.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Severe (n=127, 131)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Any (n=135, 155)	10.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Mild (n=132, 149)	6.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Moderate (n=132, 138)	7.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Severe (n=127, 132)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Any (n=175, 231)	58.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Mild (n=170, 205)	52.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Moderate (n=143, 176)	21.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Severe (n=127, 140)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Any (n=142, 178)	28.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Mild (n=142, 171)	26.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Moderate (n=127, 134)	3.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Severe (n=128, 135)	2.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Severe (n=128, 135)	8.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Any (n=134, 151)	27.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Any (n=175, 231)	85.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Mild (n=134, 144)	19.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Any (n=142, 178)	53.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Moderate (n=128, 138)	12.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Mild (n=170, 205)	78.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Redness: Severe (n=127, 131)	6.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Moderate (n=127, 134)	10.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Any (n=135, 155)	25.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Moderate (n=143, 176)	49.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Mild (n=132, 149)	20.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Limitation of arm movement: Mild (n=142, 171)	47.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Moderate (n=132, 138)	12.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Pain: Severe (n=127, 140)	12.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Swelling: Severe (n=127, 132)	6.1 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC

Time frame: 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Any (n=86, 155, 119)	14.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Mild (n=83, 144, 115)	7.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Moderate (n=83, 138, 115)	7.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Severe (n=83, 131, 115)	2.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Any (n=86, 151, 115)	12.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Mild (n=85, 149, 119)	10.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Moderate (n=82, 138, 116)	6.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Severe (n=82, 132, 115)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Any (n=129, 231, 169)	75.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Mild (n=123, 205, 166)	72.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Moderate (n=91, 176, 129)	24.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Severe (n=83, 140, 116)	2.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Any (n=93, 178, 130)	28.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Mild (n=92, 171, 130)	27.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Moderate(n=83,134,115)	3.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Severe (n=82, 135,115)	1.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Mild (n=85, 149, 119)	20.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Moderate (n=82, 138, 116)	12.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Severe (n=82, 132, 115)	6.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Mild (n=92, 171, 130)	47.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Any (n=129, 231, 169)	85.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Mild (n=123, 205, 166)	78.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Severe (n=82, 135,115)	8.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Moderate (n=91, 176, 129)	49.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Any (n=86, 151, 115)	27.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Moderate(n=83,134,115)	10.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Mild (n=83, 144, 115)	19.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Severe (n=83, 140, 116)	12.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Moderate (n=83, 138, 115)	12.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Severe (n=83, 131, 115)	6.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Any (n=86, 155, 119)	25.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Any (n=93, 178, 130)	53.4 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Moderate (n=91, 176, 129)	17.8 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Mild (n=85, 149, 119)	5.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Any (n=93, 178, 130)	18.5 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Moderate (n=83, 138, 115)	0.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Moderate (n=82, 138, 116)	0.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Severe (n=82, 135,115)	1.7 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Any (n=86, 151, 115)	4.3 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Severe (n=82, 132, 115)	0.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Severe (n=83, 140, 116)	0.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Swelling: Any (n=86, 155, 119)	5.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Any (n=129, 231, 169)	69.8 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Mild (n=92, 171, 130)	16.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Mild (n=83, 144, 115)	4.3 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Pain: Mild (n=123, 205, 166)	68.1 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Redness: Severe (n=83, 131, 115)	0.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Limitation of arm movement: Moderate(n=83,134,115)	0.0 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)

Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Aggravated joint pain (n=62, 62)	16.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=55, 55)	7.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=55, 55)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Severe ≥39 but ≤40 degrees C (n=55, 55)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever Potentially life threatening >40C (n=55, 55)	1.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fatigue (n=76, 76)	56.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Headache (n=76, 76)	52.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Chills (n=61, 61)	18.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Rash (n=60, 60)	8.3 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Vomiting (n=56, 56)	7.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Decreased appetite (n=61, 61)	13.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	New muscle pain (n=84, 84)	47.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Aggravated muscle pain (n=68, 68)	26.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	New joint pain (n=62, 62)	14.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Any ≥38 degrees C (n=55, 55)	9.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Decreased appetite (n=61, 61)	21.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Any ≥38 degrees C (n=55, 55)	3.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Chills (n=61, 61)	19.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=55, 55)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Aggravated muscle pain (n=68, 68)	30.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=55, 55)	1.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Aggravated joint pain (n=62, 62)	19.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Rash (n=60, 60)	10.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever: Severe ≥39 but ≤40 degrees C (n=55, 55)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	New muscle pain (n=84, 84)	51.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fever Potentially life threatening >40C (n=55, 55)	1.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Vomiting (n=56, 56)	3.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Fatigue (n=76, 76)	43.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	New joint pain (n=62, 62)	16.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Headache (n=76, 76)	44.7 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever Potentially life threatening >40C(n=258,115)	0.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Rash (n=267, 121)	8.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=263, 116)	3.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Vomiting (n=261, 118)	3.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fatigue (n=321, 141)	50.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Decreased appetite (n=278, 123)	14.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Severe ≥39 but ≤40 degrees C(n=259,115)	0.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	New muscle pain (n=324, 151)	46.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Headache (n=328, 139)	49.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Aggravated muscle pain (n=286, 136)	22.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=259,115)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	New joint pain (n=278, 128)	15.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Chills (n=286, 127)	19.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Aggravated joint pain (n=272, 131)	14.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Any ≥38 degrees C (n=263, 116)	4.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Aggravated joint pain (n=272, 131)	21.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Any ≥38 degrees C (n=263, 116)	0.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=263, 116)	0.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=259,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever: Severe ≥39 but ≤40 degrees C(n=259,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fever Potentially life threatening >40C(n=258,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Fatigue (n=321, 141)	41.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Headache (n=328, 139)	40.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Chills (n=286, 127)	19.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Rash (n=267, 121)	8.3 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Vomiting (n=261, 118)	6.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Decreased appetite (n=278, 123)	13.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	New muscle pain (n=324, 151)	45.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Aggravated muscle pain (n=286, 136)	28.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	New joint pain (n=278, 128)	19.5 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])

Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever Potentially life threatening >40C(n=258,127)	0.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Rash (n=267, 134)	8.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Mild ≥38 but <38.5 degrees C (n=263, 127)	3.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Vomiting (n=261, 131)	3.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fatigue (n=321, 173)	50.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Decreased appetite (n=278, 148)	14.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Severe ≥39 but ≤40 degrees C (n=259, 127)	0.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	New muscle pain (n=324, 167)	46.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Headache (n=328, 167)	49.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Aggravated muscle pain (n=286, 154)	22.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Moderate ≥38.5 but <39 degrees C(n=259,127)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	New joint pain (n=278, 147)	15.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Chills (n=286, 145)	19.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Aggravated joint pain (n=272, 142)	14.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Any ≥38 degrees C (n=263, 127)	4.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Aggravated joint pain (n=272, 142)	21.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Any ≥38 degrees C (n=263, 127)	1.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Mild ≥38 but <38.5 degrees C (n=263, 127)	0.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Moderate ≥38.5 but <39 degrees C(n=259,127)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever: Severe ≥39 but ≤40 degrees C (n=259, 127)	0.8 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fever Potentially life threatening >40C(n=258,127)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Fatigue (n=321, 173)	49.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Headache (n=328, 167)	46.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Chills (n=286, 145)	26.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Rash (n=267, 134)	13.4 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Vomiting (n=261, 131)	3.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Decreased appetite (n=278, 148)	23.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	New muscle pain (n=324, 167)	51.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Aggravated muscle pain (n=286, 154)	32.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	New joint pain (n=278, 147)	23.81 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)

Time frame: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever Potentially life threatening >40C(n=127,127)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Rash (n=134, 146)	13.4 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=127, 129)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Vomiting (n=131, 131)	3.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fatigue (n=173, 185)	49.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Decreased appetite (n=148, 141)	23.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Severe ≥39 but ≤40 degrees C(n=127,127)	0.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	New muscle pain (n=167, 196)	51.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Headache (n=167, 175)	46.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Aggravated muscle pain (n=154, 164)	32.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=127,127)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	New joint pain (n=147, 153)	23.8 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Chills (n=145, 155)	26.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Aggravated joint pain (n=142, 143)	21.1 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Any ≥38 degrees C (n=127, 129)	1.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Aggravated joint pain (n=142, 143)	17.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Any ≥38 degrees C (n=127, 129)	3.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Mild ≥38 but <38.5 degrees C (n=127, 129)	3.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Moderate ≥38.5 but <39 degrees C(n=127,127)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever: Severe ≥39 but ≤40 degrees C(n=127,127)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fever Potentially life threatening >40C(n=127,127)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Fatigue (n=173, 185)	51.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Headache (n=167, 175)	49.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Chills (n=145, 155)	29.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Rash (n=134, 146)	24.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Vomiting (n=131, 131)	4.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Decreased appetite (n=148, 141)	17.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	New muscle pain (n=167, 196)	61.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Aggravated muscle pain (n=154, 164)	41.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	New joint pain (n=147, 153)	25.5 percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC

Time frame: 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Potentially life threatening >40C(n=81,127,115)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated muscle pain (n=94, 164, 136)	26.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Rash (n=86, 146, 121)	10.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Severe ≥39, ≤40 degrees C(n=81,127,115)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New muscle pain (n=108, 196, 151)	50.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Vomiting (n=82, 131, 118)	3.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Any ≥38 degrees C (n=81, 129, 116)	2.5 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Decreased appetite (n=89, 141, 123)	18.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fatigue (n=100, 185, 141)	39.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Moderate ≥38.5, <39 degrees C(n=81,127,115)	1.2 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated joint pain (n=91, 143, 131)	17.6 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Headache (n=96, 175, 139)	41.7 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Mild ≥38 but <38.5 degrees C (n=81,129,116)	0.0 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New joint pain (n=87, 153, 128)	14.9 percentage of participants
13vPnC / 23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Chills (n=90, 155, 127)	18.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Any ≥38 degrees C (n=81, 129, 116)	3.1 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Severe ≥39, ≤40 degrees C(n=81,127,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Potentially life threatening >40C(n=81,127,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fatigue (n=100, 185, 141)	51.9 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Headache (n=96, 175, 139)	49.7 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Chills (n=90, 155, 127)	29.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Rash (n=86, 146, 121)	24.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Vomiting (n=82, 131, 118)	4.6 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Decreased appetite (n=89, 141, 123)	17.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New muscle pain (n=108, 196, 151)	61.2 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated muscle pain (n=94, 164, 136)	41.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New joint pain (n=87, 153, 128)	25.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated joint pain (n=91, 143, 131)	17.5 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Moderate ≥38.5, <39 degrees C(n=81,127,115)	0.0 percentage of participants
23vPS	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Mild ≥38 but <38.5 degrees C (n=81,129,116)	3.1 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Any ≥38 degrees C (n=81, 129, 116)	0.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated muscle pain (n=94, 164, 136)	28.7 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Headache (n=96, 175, 139)	40.3 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Severe ≥39, ≤40 degrees C(n=81,127,115)	0.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New joint pain (n=87, 153, 128)	19.5 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fatigue (n=100, 185, 141)	41.1 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Moderate ≥38.5, <39 degrees C(n=81,127,115)	0.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Aggravated joint pain (n=91, 143, 131)	21.4 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Vomiting (n=82, 131, 118)	6.8 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Potentially life threatening >40C(n=81,127,115)	0.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Decreased appetite (n=89, 141, 123)	13.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Rash (n=86, 146, 121)	8.3 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Fever: Mild ≥38 but <38.5 degrees C (n=81,129,116)	0.9 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	New muscle pain (n=108, 196, 151)	45.0 percentage of participants
23vPS / 13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Chills (n=90, 155, 127)	19.7 percentage of participants

Other Pre-specified

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)

Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	207 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	75 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	2536 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	215 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	1948 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	1063 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	767 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	650 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	1576 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	709 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	711 geometric mean titer
13vPnC / 23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	354 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19F	286 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 1	77 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 9V	114 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 3	50 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 19A	289 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 4	935 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 14	435 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 5	85 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 23F	124 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 6B	710 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 18C	564 geometric mean titer
23vPS	Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Common Serotype 7F	126 geometric mean titer

Comparison: Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.03, 3.55]

Comparison: Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.18, 1.89]

Comparison: Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.07, 3.55]

Comparison: Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.77, 3.61]

Comparison: Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.94, 3.88]

Comparison: Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [5.68, 12.6]

Comparison: Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [4.45, 10.22]

Comparison: Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.02, 2.18]

Comparison: Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [2.01, 3.89]

Comparison: Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.92, 3.13]

Comparison: Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.8, 3.44]

Comparison: Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.95% CI: [1.92, 4.28]

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026

Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)