Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Conditions

Pneumococcal Infections

Keywords

Vaccine, Pneumococcal Infections Prevention and Control

Brief summary

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Related papers

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Interventions

BIOLOGICAL13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

BIOLOGICAL23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

0.5 mL dose administered on day 1

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment. * Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment. * Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion criteria

* Previous immunization with any licensed or experimental pneumococcal vaccine. * Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which in the investigator's opinion precludes the subject from participating in the study. * Known or suspected impairment of immunological function.

Design outcomes

Primary

Measure	Time frame	Description
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	One month after vaccination 1	Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4	Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1	One month after vaccination 1	For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.

Secondary

Measure	Time frame	Description
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4	Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	One month after vaccination 1	Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4	Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Other

Measure	Time frame	Description
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Within 14 days after vaccination 2	Systemic events reported using an electronic diary. Systemic events are any fever \>=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Within 14 days after vaccination 1	Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Within 14 days after vaccination 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 \[lim\] 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 3 to 4) in Cohort 1 and Cohort 2	Within 14 days after vaccination 2	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 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

Pre-assignment details

Participants in Cohort 1 and 2 participated for 1 year in the study. Vaccination 2 (3 to 4 years after vaccination 1) was administered to participants in Cohort 1 and 2. Participants in Cohort 3 enrolled as part of amendment 3 participated for 6 months and participants in Cohort 3 enrolled as part of amendment 4 participated for 1 year in study.

Participants by arm

Arm	Count
13vPnC, Cohort 1 Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \[Vax1\]).	417
23vPS, Cohort 1 Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).	414
13vPnC, Cohort 2 Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).	403
13vPnC, Cohort 3 Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).	899
Total	2,133

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG007
Between 6-Month Follow-up - Year 1	Did not enter 1-year blood draw	0	0	0	352	0	0
Between Year 1 - Vax 2/Year 3 to 4	Did Not Consent to Receive Vax 2	188	207	159	469	0	0
Vax 1 Baseline/6-Month Follow-up	Failed to Return	0	0	0	2	0	0
Vax 1 Baseline/6-Month Follow-up	Lost to Follow-up	0	1	4	32	0	0
Vax 1 Baseline/6-Month Follow-up	Other	0	0	1	2	0	0
Vax 1 Baseline/6-Month Follow-up	Physician Decision	1	1	0	0	0	0
Vax 1 Baseline/6-Month Follow-up	Protocol Violation	4	0	3	2	0	0
Vax 1 Baseline/6-Month Follow-up	Randomized, Not Vaccinated	1	3	2	1	0	0
Vax 1 Baseline/6-Month Follow-up	Withdrawal by Subject	1	1	4	7	0	0
Vax 1/Year 1 Follow-up	Adverse Event	0	1	0	0	0	0
Vax 1/Year 1 Follow-up	Death	1	0	0	0	0	0
Vax 1/Year 1 Follow-up	Failed to Return	0	0	12	5	0	0
Vax 1/Year 1 Follow-up	Lost to Follow-up	0	5	2	21	0	0
Vax 1/Year 1 Follow-up	Other	0	0	0	2	0	0
Vax 1/Year 1 Follow-up	Protocol Violation	3	3	0	1	0	0
Vax 1/Year 1 Follow-up	Withdrawal by Subject	3	6	5	4	0	0
Vax 2/Year 3 to 4	Failed to Return	0	0	0	0	1	0
Vax 2/Year 3 to 4	Lost to Follow-up	0	0	0	0	0	1
Vax 2/Year 3 to 4	Protocol Violation	0	0	0	0	0	1

Baseline characteristics

Characteristic	13vPnC, Cohort 1	23vPS, Cohort 1	13vPnC, Cohort 2	13vPnC, Cohort 3	Total
Age, Customized 18 to 29 years	0 participants	0 participants	0 participants	300 participants	300 participants
Age, Customized 30 to 39 years	0 participants	0 participants	0 participants	298 participants	298 participants
Age, Customized 40 to 49 years	0 participants	0 participants	0 participants	301 participants	301 participants
Age, Customized 50 to 59 years	0 participants	0 participants	403 participants	0 participants	403 participants
Age, Customized 60 to 64 years	417 participants	414 participants	0 participants	0 participants	831 participants
Sex: Female, Male Female	223 Participants	252 Participants	249 Participants	523 Participants	1247 Participants
Sex: Female, Male Male	194 Participants	162 Participants	154 Participants	376 Participants	886 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	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	277 / 417	0 / 417	271 / 414	5 / 414	293 / 403	2 / 403	66 / 108	1 / 108	73 / 108	4 / 108	143 / 189	13 / 189	164 / 214	4 / 214	779 / 899	1 / 899
serious Total, serious adverse events	1 / 417	12 / 417	2 / 414	10 / 414	2 / 403	5 / 403	1 / 108	2 / 108	1 / 108	1 / 108	0 / 189	3 / 189	0 / 214	0 / 214	2 / 899	2 / 899

Outcome results

Primary

Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1

For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.

Time frame: One month after vaccination 1

Population: Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.

Arm	Measure	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1	88.5 percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1	49.3 percentage of participants

95% CI: [33, 45.1]

Primary

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1

Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Time frame: One month after vaccination 1

Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	7F	1120 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	23F	375 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	18C	1726 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	9V	1164 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	3	93 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	14	612 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	4	2062 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	1	146 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19F	517 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	5	199 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6A	2593 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19A	682 titer
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6B	1984 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	1	104 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	7F	405 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	14	692 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	18C	925 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	5	162 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	9V	407 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19A	352 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6B	788 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	3	85 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	23F	72 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19F	539 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6A	213 titer
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	4	1295 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	18C	1939 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	1	200 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	3	91 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	4	2833 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6A	4328 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6B	3212 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	7F	1520 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	9V	1726 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	14	957 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	5	269 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19A	956 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19F	599 titer
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	23F	494 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	1	353 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6A	5746 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	5	386 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	18C	3989 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19A	1580 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	4	4747 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	3	91 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	23F	1570 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	9V	3339 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	19F	1533 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	14	2983 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	7F	3249 titer
13vPnC/13vPnC, Cohort 2	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	6B	9813 titer

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.1, 1.78]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.9, 1.32]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.19, 2.13]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.93, 1.62]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [8.63, 17.08]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.82, 3.48]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.98, 3.87]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [2, 4.08]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.64, 1.21]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.39, 2.51]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [1.56, 2.41]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [0.72, 1.28]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).95% CI: [3.67, 7.33]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.08, 1.73]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [0.81, 1.19]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.07, 1.77]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.01, 1.8]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.3, 2.15]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.24, 2.12]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.03, 1.79]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.11, 1.98]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.16, 2.12]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [0.86, 1.47]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [1.16, 1.69]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [0.87, 1.54]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.95% CI: [0.94, 1.84]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [2.03, 2.87]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [0.84, 1.13]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [1.92, 2.76]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [1.55, 2.42]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [1.84, 2.67]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [4.13, 5.93]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [2.41, 3.49]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [2.34, 3.52]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [4.01, 5.93]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [1.91, 2.79]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [2.02, 2.66]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [2.44, 3.6]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.95% CI: [3.31, 5.31]

Primary

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group

Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Time frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19F	1653 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	6B	2670 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19A	966 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	3	164 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	7F	1895 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	5	476 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	23F	299 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	9V	1089 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	4	1875 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	14	1268 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	1	398 titers
13vPnC/13vPnC, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	18C	2489 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	1	116 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	18C	1135 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19A	377 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19F	621 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	23F	86 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	4	1420 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	5	149 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	6B	1088 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	7F	403 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	3	105 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	9V	654 titers
23vPS/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	14	824 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	23F	54 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	5	74 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	9V	187 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	1	95 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	3	53 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	4	733 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	6B	916 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	7F	497 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	14	661 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	18C	802 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19A	364 titers
13vPnC/23vPS, Cohort 1	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	19F	374 titers

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [2.32, 5.09]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.13, 2.16]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.88, 1.98]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [2.04, 4.97]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.5, 4]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [2.76, 7.99]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.93, 2.97]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.99, 2.39]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.37, 3.5]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.78, 3.68]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.77, 4.01]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.99, 6.13]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.87, 6.08]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.26, 4.3]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.72, 3.8]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [4.09, 10.19]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.83, 4.63]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.41, 6.03]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [3.13, 10.82]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.3, 2.84]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.02, 4.78]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.87, 3.76]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.97, 6.58]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [3.2, 9.41]

Secondary

Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1

Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.

Time frame: One month after vaccination 1

Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	23F	84.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19F	89.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	5	87.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	3	92.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19A	98.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	14	87.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6A	95.8 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	9V	89.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	1	90.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	18C	95.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6B	93.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	7F	90.4 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	4	95.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	1	83.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	7F	78.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	23F	61.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	9V	75.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	3	88.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	18C	89.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19F	90.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	4	91.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	5	84.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19A	94.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6A	69.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6B	86.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	14	88.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	18C	94.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	1	94.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	3	92.3 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	5	86.1 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6A	97.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6B	97.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	7F	94.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	9V	93.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	14	92.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	4	97.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19A	98.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19F	91.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	23F	85.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	1	97.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	18C	98.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	5	92.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	9V	97.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19A	99.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	4	99.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	3	94.8 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	23F	95.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	7F	98.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6B	99.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	19F	98.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	14	99.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	6A	99.4 Percentage of participants

Comparison: Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [1.9, 11.2]

Comparison: Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.3, 8.1]

Comparison: Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.2, 7.2]

Comparison: Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-2.6, 7.2]

Comparison: Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [21.7, 31.7]

Comparison: Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [3.2, 12]

Comparison: Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [7.3, 17.4]

Comparison: Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [8.7, 19.5]

Comparison: Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-5.6, 3.8]

Comparison: Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [2.6, 10.5]

Comparison: Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [1.2, 7.1]

Comparison: Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.95% CI: [-5.5, 3.2]

Comparison: Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [17, 29.3]

Comparison: Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.2, 7.5]

Comparison: Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-3.6, 4.1]

Comparison: Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.4, 5.5]

Comparison: Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-5.8, 3.9]

Comparison: Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.4, 4.8]

Comparison: Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [0.8, 7.2]

Comparison: Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [0.6, 8.2]

Comparison: Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.3, 7.9]

Comparison: Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.1, 8.7]

Comparison: Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-3.8, 2.5]

Comparison: Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-0.3, 5.9]

Comparison: Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-2.1, 1.9]

Comparison: Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-2.4, 6.2]

Comparison: Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [-4.7, 5.7]

Comparison: Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [4.3, 10.6]

Comparison: Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [2.1, 6.9]

Comparison: Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [1.4, 9.1]

Comparison: Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [1.7, 6.1]

Comparison: Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [4.1, 9.3]

Comparison: Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [5.4, 11.6]

Comparison: Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [4.8, 11.4]

Comparison: Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [8, 14.9]

Comparison: Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [0.9, 5.7]

Comparison: Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [0.3, 3.1]

Comparison: Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [5.4, 12]

Comparison: Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.95% CI: [6.8, 14.7]

Secondary

Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2

Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Time frame: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4

Population: Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	1	72.6 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	3	13.2 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	4	68.0 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	5	47.9 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6A	142.0 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6B	103.3 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	7F	140.8 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	9V	24.7 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	14	20.6 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	18C	67.9 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19A	37.6 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19F	54.1 Fold Rise
13vPnC/13vPnC, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	23F	115.7 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	5	83.2 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	23F	32.5 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19A	43.1 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	9V	40.1 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	4	110.4 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	1	69.7 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	18C	80.9 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	14	36.6 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6B	63.6 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6A	116.2 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	3	21.2 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19F	110.3 Fold Rise
23vPS/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	7F	293.9 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19A	15.4 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	5	11.9 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6A	6.4 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	23F	6.4 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6B	24.9 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	7F	72.1 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19F	25.1 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	9V	10.6 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	14	19.9 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	18C	27.5 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	1	15.6 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	3	6.8 Fold Rise
13vPnC/23vPS, Cohort 1	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	4	43.8 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	18C	94.9 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	9V	49.9 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	5	52.8 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	1	54.0 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	7F	218.0 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6B	132.7 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	4	104.2 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	3	11.5 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	6A	139.7 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	14	26.6 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	23F	130.0 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19F	60.4 Fold Rise
13vPnC/13vPnC, Cohort 2	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	19A	30.9 Fold Rise

Secondary

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination

Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Time frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Population: Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	23F	7.11 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	7F	8.52 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	5	11.52 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	4	3.68 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19F	11.51 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19A	14.63 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	18C	8.56 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	1	9.53 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	6B	11.50 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	14	16.07 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	9V	7.39 mcg/mL
13vPnC/13vPnC, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	3	2.58 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	18C	8.21 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	6B	7.81 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	1	4.13 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	3	1.88 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	4	1.59 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	5	8.23 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	7F	8.24 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	9V	5.50 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	14	12.05 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19A	12.70 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19F	6.42 mcg/mL
23vPS/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	23F	4.89 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	3	1.81 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19F	3.44 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	9V	3.78 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	1	4.36 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	14	8.22 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	23F	3.56 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	5	5.78 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	18C	6.30 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19A	9.88 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	4	1.49 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	7F	4.61 mcg/mL
13vPnC/23vPS, Cohort 1	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	6B	5.65 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	3	1.33 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	7F	6.26 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	1	6.92 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	18C	7.17 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	5	7.23 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	9V	4.97 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	6B	19.07 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19F	12.89 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	19A	16.33 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	14	14.66 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	23F	17.20 mcg/mL
13vPnC/13vPnC, Cohort 2	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	4	4.89 mcg/mL

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.52, 3.51]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.95, 1.99]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.47, 3.64]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.92, 2.12]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.01, 2.16]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.67, 1.59]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.94, 1.92]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.8, 2.23]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.68, 1.59]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.8, 1.66]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [1.07, 3]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).95% CI: [0.95, 2.24]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.53, 3.12]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.06, 1.91]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.71, 3.55]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.45, 2.74]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.5, 2.76]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.32, 2.58]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.46, 2.62]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.32, 2.91]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [0.94, 1.97]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.08, 2.03]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [2.19, 5.12]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).95% CI: [1.41, 2.83]

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 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 \[lim\] 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: Within 14 days after vaccination 1

Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Any	20.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Any	19.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Moderate	23.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Severe	0.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Mild	15.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Mild	15.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Severe	1.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Moderate	8.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Moderate	2.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Mild	26.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Mild	78.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Moderate	8.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Severe	1.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Severe	1.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Any	80.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Any	28.5 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Severe	1.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Any	30.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Mild	29.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Severe	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Moderate	3.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Severe	4.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Any	13.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Mild	10.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Mild	11.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Moderate	4.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Any	14.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Any	73.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Mild	68.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Moderate	4.9 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Moderate	30.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Severe	8.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Any	15.8 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Severe	2.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Moderate	39.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Any	88.8 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Severe	0.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Moderate	2.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Moderate	5.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Mild	85.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Any	40.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Mild	20.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Mild	38.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Moderate	4.3 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Mild	15.2 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Any	21.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Severe	3.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Severe	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Severe	15.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Any	30.5 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Mild	26.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Moderate	11.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Redness: Severe	2.8 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Any	39.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Mild	37.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Moderate	15.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Swelling: Severe	1.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Any	96.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Mild	93.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Moderate	77.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Pain: Severe	16.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Any	75.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Mild	71.5 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1	Lim of arm movement:Moderate	18.5 Percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2

Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 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: Within 14 days after vaccination 2

Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Any	24.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Mild	20.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Moderate	6.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Severe	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Any	20.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Mild	21.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Moderate	10.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Severe	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Any	78.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Mild	76.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Moderate	24.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Severe	2.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Any	27.8 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Mild	24.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement:Moderate	4.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Severe	2.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Mild	20.9 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Any	84.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Severe	9.5 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Severe	11.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement:Moderate	3.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Mild	80.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Moderate	18.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Moderate	51.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Any	35.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Moderate	24.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Severe	10.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Mild	27.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Any	48.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Severe	7.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Mild	46.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Any	35.8 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Mild	18.8 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Any	20.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Mild	40.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Moderate	7.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Severe	2.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Severe	4.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Any	83.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Mild	81.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement:Moderate	7.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Moderate	44.1 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Severe	9.1 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Any	27.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Mild	22.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Any	42.1 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Moderate	11.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Severe	2.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Severe	5.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Severe	1.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Moderate	5.3 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Any	21.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Mild	48.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Moderate	4.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement: Any	51.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Mild	18.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Any	22.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Mild	90.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Swelling: Mild	21.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Moderate	53.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Limitation of arm movement:Moderate	9.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Any	93.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Redness: Severe	1.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Pain: Severe	5.3 Percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1

Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.

Time frame: Within 14 days after vaccination 1

Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen muscle pain	56.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fatigue	63.2 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >40 degrees C	4.4 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38.5 to <39 degrees C	0.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Decreased appetite	21.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen joint pain	24.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen joint pain	24.4 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Vomiting	3.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Rash	16.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 degrees C	7.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen muscle pain	32.6 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Chills	23.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Headache	54.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 to <38.5 degrees C	3.9 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen joint pain	30.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen joint pain	21.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 degrees C	5.9 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 to <38.5 degrees C	1.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38.5 to <39 degrees C	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >40 degrees C	4.9 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fatigue	61.5 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Headache	54.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Chills	24.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Rash	13.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Vomiting	5.4 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Decreased appetite	21.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen muscle pain	57.8 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen muscle pain	37.3 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 to <38.5 degrees C	1.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen joint pain	31.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fatigue	63.3 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen muscle pain	39.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Headache	65.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 degrees C	1.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen muscle pain	61.8 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Rash	14.2 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen joint pain	25.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Vomiting	6.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Decreased appetite	25.3 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38.5 to <39 degrees C	0.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Chills	19.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Decreased appetite	55.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Vomiting	15.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >40 degrees C	0.5 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fatigue	80.5 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 degrees C	7.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen joint pain	41.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen muscle pain	55.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Headache	81.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=39 to =<40 degrees C	1.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38.5 to <39 degrees C	1.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Chills	38.1 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Aggravated gen joint pain	28.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	New gen muscle pain	82.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Fever >=38 to <38.5 degrees C	4.2 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Rash	21.3 Percentage of participants

Other Pre-specified

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2

Systemic events reported using an electronic diary. Systemic events are any fever \>=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.

Time frame: Within 14 days after vaccination 2

Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Vomiting	8.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Rash	23.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Chills	23.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized joint pain	13.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Headache	38.3 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fatigue	50.7 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized joint pain	18.9 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >= 38 to <38.5 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38 degrees C	2.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized muscle pain	27.5 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38.5 to <39 degrees C	2.1 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized muscle pain	55.0 Percentage of participants
13vPnC/13vPnC, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Decreased appetite	21.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized muscle pain	67.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fatigue	57.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38 degrees C	2.5 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >= 38 to <38.5 degrees C	2.5 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38.5 to <39 degrees C	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >40 degrees C	0.0 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Headache	54.2 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Chills	34.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Rash	32.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Vomiting	1.3 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Decreased appetite	23.7 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized muscle pain	39.6 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized joint pain	23.1 Percentage of participants
23vPS/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized joint pain	17.6 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized muscle pain	65.2 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized joint pain	24.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >= 38 to <38.5 degrees C	2.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Vomiting	4.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized muscle pain	41.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Rash	18.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38.5 to <39 degrees C	2.4 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fatigue	63.2 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38 degrees C	4.7 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >40 degrees C	0.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Decreased appetite	31.5 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Headache	50.0 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Chills	33.9 Percentage of participants
13vPnC/23vPS, Cohort 1	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized joint pain	22.4 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=39 to =<40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Chills	25.8 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Rash	13.6 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38.5 to <39 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized joint pain	33.3 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Vomiting	3.9 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Decreased appetite	24.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >= 38 to <38.5 degrees C	2.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	New generalized muscle pain	69.5 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized joint pain	25.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Aggravated generalized muscle pain	34.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >40 degrees C	0.0 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fatigue	60.8 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Fever >=38 degrees C	2.7 Percentage of participants
13vPnC/13vPnC, Cohort 2	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Headache	61.8 Percentage of participants

Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group

Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1

Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2