Trial Outcomes & Findings for 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan (NCT NCT04875533)

Last Updated: 2024-11-05

Results Overview

Reactions were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), and severe (\>10.0 cm). Pain at the injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1425 participants

Primary outcome timeframe

Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Results posted on

2024-11-05

Participant Flow

Participants 60 years of age and above were recruited into this study to received either Pneumococcal Conjugate Vaccine (20vPnC)/saline or 13-valent pneumococcal conjugate vaccine (13vPnC)/23-valent pneumococcal polysaccharide vaccine (PPSV23).

A total of 1425 participants were randomized to receive either 20vPnC/saline (713 participants) or 13vPnC/PPSV23 (712 participants); 2 participants in the 20vPnC/saline group and 2 participants in the 13vPnC/PPSV23 group were not vaccinated, therefore, a total of 1421 participants were vaccinated and included in the summary..

Participant milestones

Participant milestones
Measure	20vPnC/Saline Participants aged 60 years and above received a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Overall Study STARTED	711	710
Overall Study Vaccinated With Vaccination 2	695	699
Overall Study COMPLETED	692	699
Overall Study NOT COMPLETED	19	11

Reasons for withdrawal

Reasons for withdrawal
Measure	20vPnC/Saline Participants aged 60 years and above received a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Overall Study Adverse Event	6	4
Overall Study Protocol Violation	4	0
Overall Study Withdrawal by Subject	8	5
Overall Study No longer meets eligibility criteria	1	0
Overall Study Other	0	2

Baseline Characteristics

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20vPnC/Saline n=711 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=710 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).	Total n=1421 Participants Total of all reporting groups
Age, Continuous	66.0 Years STANDARD_DEVIATION 4.46 • n=5 Participants	66.2 Years STANDARD_DEVIATION 4.83 • n=7 Participants	66.1 Years STANDARD_DEVIATION 4.65 • n=5 Participants
Age, Customized 60 to 64 years	314 Participants n=5 Participants	314 Participants n=7 Participants	628 Participants n=5 Participants
Age, Customized 65 to 74 years	366 Participants n=5 Participants	353 Participants n=7 Participants	719 Participants n=5 Participants
Age, Customized ≥75 years	31 Participants n=5 Participants	43 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Female	315 Participants n=5 Participants	315 Participants n=7 Participants	630 Participants n=5 Participants
Sex: Female, Male Male	396 Participants n=5 Participants	395 Participants n=7 Participants	791 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	711 Participants n=5 Participants	710 Participants n=7 Participants	1421 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	711 Participants n=5 Participants	710 Participants n=7 Participants	1421 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed"=number of participants with any e-diary data reported after 20vPnC or 13vPnC.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=710 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=710 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Swelling-Any	10.4 percentage of participants Interval 8.3 to 12.9	7.5 percentage of participants Interval 5.6 to 9.7
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Swelling-Mild	5.4 percentage of participants Interval 3.8 to 7.3	3.5 percentage of participants Interval 2.3 to 5.2
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Swelling-Severe	0.6 percentage of participants Interval 0.2 to 1.4	0.8 percentage of participants Interval 0.3 to 1.8
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Pain at the injection site-Any	52.3 percentage of participants Interval 48.5 to 56.0	50.7 percentage of participants Interval 47.0 to 54.4
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Redness-Any	12.4 percentage of participants Interval 10.1 to 15.0	9.7 percentage of participants Interval 7.6 to 12.1
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Redness-Mild	6.2 percentage of participants Interval 4.5 to 8.2	4.5 percentage of participants Interval 3.1 to 6.3
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Redness-Moderate	4.8 percentage of participants Interval 3.3 to 6.6	3.9 percentage of participants Interval 2.6 to 5.6
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Redness-Severe	1.4 percentage of participants Interval 0.7 to 2.6	1.3 percentage of participants Interval 0.6 to 2.4
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Swelling-Moderate	4.5 percentage of participants Interval 3.1 to 6.3	3.1 percentage of participants Interval 2.0 to 4.7
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Pain at the injection site-Mild	45.6 percentage of participants Interval 41.9 to 49.4	46.3 percentage of participants Interval 42.6 to 50.1
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Pain at the injection site-Moderate	6.5 percentage of participants Interval 4.8 to 8.5	4.1 percentage of participants Interval 2.8 to 5.8
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC) Pain at the injection site-Severe	0.1 percentage of participants Interval 0.0 to 0.8	0.3 percentage of participants Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is number of participants with any e-diary data reported after 20vPnC or 13vPnC.

Events were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Fever was categorized as ≥38.0 degree Celsius (°C), ≥38.0°C to 38.4°C, \>38.4°C to 38.9°C, \>38.9°C to 40.0°C, and \>40.0°C. Fatigue, headache, muscle pain, and joint pain were graded as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=710 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=710 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Joint pain-Any	6.8 percentage of participants Interval 5.0 to 8.9	7.9 percentage of participants Interval 6.0 to 10.1
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fever >40.0°C	0 percentage of participants Interval 0.0 to 0.5	0 percentage of participants Interval 0.0 to 0.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fatigue-Any	20.7 percentage of participants Interval 17.8 to 23.9	23.0 percentage of participants Interval 19.9 to 26.2
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fatigue-Severe	0 percentage of participants Interval 0.0 to 0.5	0.3 percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Muscle pain-Moderate	2.3 percentage of participants Interval 1.3 to 3.6	3.0 percentage of participants Interval 1.8 to 4.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Muscle pain-Severe	0.1 percentage of participants Interval 0.0 to 0.8	0.1 percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Joint pain-Mild	5.2 percentage of participants Interval 3.7 to 7.1	5.9 percentage of participants Interval 4.3 to 7.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Joint pain-Moderate	1.5 percentage of participants Interval 0.8 to 2.8	2.0 percentage of participants Interval 1.1 to 3.3
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Joint pain-Severe	0 percentage of participants Interval 0.0 to 0.5	0 percentage of participants Interval 0.0 to 0.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fever ≥38.0°C	0.1 percentage of participants Interval 0.0 to 0.8	0.6 percentage of participants Interval 0.2 to 1.4
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fever ≥38.0°C to 38.4°C	0.1 percentage of participants Interval 0.0 to 0.8	0.3 percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fever >38.4°C to 38.9°C	0 percentage of participants Interval 0.0 to 0.5	0.1 percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fever >38.9°C to 40.0°C	0 percentage of participants Interval 0.0 to 0.5	0.1 percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fatigue-Mild	18.0 percentage of participants Interval 15.3 to 21.1	18.9 percentage of participants Interval 16.1 to 21.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Fatigue-Moderate	2.7 percentage of participants Interval 1.6 to 4.1	3.8 percentage of participants Interval 2.5 to 5.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Headache-Any	9.2 percentage of participants Interval 7.1 to 11.5	11.0 percentage of participants Interval 8.8 to 13.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Headache-Mild	8.2 percentage of participants Interval 6.3 to 10.4	9.6 percentage of participants Interval 7.5 to 12.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Headache-Moderate	1.0 percentage of participants Interval 0.4 to 2.0	1.1 percentage of participants Interval 0.5 to 2.2
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Headache-Severe	0 percentage of participants Interval 0.0 to 0.5	0.3 percentage of participants Interval 0.0 to 1.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Muscle pain-Any	17.6 percentage of participants Interval 14.9 to 20.6	17.9 percentage of participants Interval 15.1 to 20.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC) Muscle pain-Mild	15.2 percentage of participants Interval 12.6 to 18.1	14.8 percentage of participants Interval 12.3 to 17.6

PRIMARY outcome

Timeframe: Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=711 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=710 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	5.6 percentage of participants Interval 4.0 to 7.6	5.9 percentage of participants Interval 4.3 to 7.9

PRIMARY outcome

Timeframe: Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)

Population: Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=711 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=710 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)	0.4 percentage of participants Interval 0.1 to 1.2	0.6 percentage of participants Interval 0.2 to 1.4

PRIMARY outcome

Timeframe: 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Participants analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations (PDs). Number Analyzed=participants evaluable for this outcome measure (OM) at specified row.

OPA titers were determined for the 13 matching pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. GMTs and 2-sided CIs were calculated by exponentiating the Least Square (LS) means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=688 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=689 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 5	96 titer Interval 82.0 to 112.0	125 titer Interval 107.0 to 145.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19A	864 titer Interval 750.0 to 994.0	1172 titer Interval 1018.0 to 1349.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 1	207 titer Interval 177.0 to 242.0	267 titer Interval 229.0 to 311.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 3	50 titer Interval 45.0 to 55.0	56 titer Interval 50.0 to 62.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 4	813 titer Interval 696.0 to 949.0	1029 titer Interval 881.0 to 1202.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6A	1286 titer Interval 1088.0 to 1520.0	1475 titer Interval 1249.0 to 1742.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6B	1399 titer Interval 1196.0 to 1637.0	1537 titer Interval 1314.0 to 1798.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 7F	1735 titer Interval 1578.0 to 1907.0	2076 titer Interval 1889.0 to 2282.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 9V	1467 titer Interval 1285.0 to 1674.0	1663 titer Interval 1459.0 to 1895.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 14	704 titer Interval 602.0 to 824.0	647 titer Interval 554.0 to 756.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 18C	1325 titer Interval 1142.0 to 1538.0	1826 titer Interval 1575.0 to 2117.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19F	365 titer Interval 310.0 to 431.0	574 titer Interval 487.0 to 676.0
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 23F	290 titer Interval 239.0 to 351.0	361 titer Interval 298.0 to 437.0

PRIMARY outcome

Timeframe: 1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.

Population: Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype) included participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or 2 respectively, had no other major PDs. Number Analyzed=participants evaluable for this OM at specified row.

OPA titers were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=689 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=693 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 10A	1661 titer Interval 1422.0 to 1939.0	777 titer Interval 667.0 to 906.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 11A	3331 titer Interval 2834.0 to 3913.0	1933 titer Interval 1644.0 to 2274.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 8	561 titer Interval 490.0 to 642.0	971 titer Interval 850.0 to 1110.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 12F	3543 titer Interval 2976.0 to 4217.0	2104 titer Interval 1766.0 to 2507.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 15B	1265 titer Interval 1039.0 to 1539.0	593 titer Interval 487.0 to 723.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 22F	2818 titer Interval 2345.0 to 3388.0	1737 titer Interval 1445.0 to 2089.0
Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 33F	6675 titer Interval 5751.0 to 7748.0	5853 titer Interval 5046.0 to 6788.0

SECONDARY outcome

Timeframe: Before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group.

Population: Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number analyzed in each row=participants evaluable with OPA titers available at both timepoints at specified serotype.

GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=688 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=689 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 3	4.8 fold rise Interval 4.4 to 5.3	5.4 fold rise Interval 4.9 to 5.9
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 9V	7.1 fold rise Interval 6.3 to 8.0	7.5 fold rise Interval 6.6 to 8.5
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19F	8.9 fold rise Interval 7.8 to 10.2	13.5 fold rise Interval 11.7 to 15.6
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 23F	18.7 fold rise Interval 15.9 to 22.0	22.2 fold rise Interval 18.8 to 26.2
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 1	13.1 fold rise Interval 11.5 to 14.9	16.3 fold rise Interval 14.2 to 18.7
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 4	30.1 fold rise Interval 26.0 to 34.9	35.7 fold rise Interval 30.5 to 41.7
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 5	5.4 fold rise Interval 4.8 to 6.0	6.9 fold rise Interval 6.1 to 7.8
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6A	24.3 fold rise Interval 20.9 to 28.3	26.9 fold rise Interval 23.0 to 31.6
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6B	14.8 fold rise Interval 12.8 to 17.3	15.7 fold rise Interval 13.5 to 18.4
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 7F	5.9 fold rise Interval 5.3 to 6.6	7.0 fold rise Interval 6.3 to 7.9
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 14	8.7 fold rise Interval 7.6 to 10.0	7.8 fold rise Interval 6.7 to 9.0
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 18C	18.6 fold rise Interval 16.0 to 21.5	24.6 fold rise Interval 21.3 to 28.5
OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19A	24.1 fold rise Interval 20.9 to 27.8	30.2 fold rise Interval 26.2 to 34.8

SECONDARY outcome

Timeframe: From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group

Population: Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype) included participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had ≥1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27-49 days after Vaccination 1 or 2 respectively, had no other major PDs.Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified serotypes

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=689 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=693 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 8	17.9 fold rise Interval 15.7 to 20.3	30.2 fold rise Interval 26.5 to 34.4
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 10A	13.1 fold rise Interval 11.4 to 15.1	6.1 fold rise Interval 5.4 to 7.0
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 33F	7.5 fold rise Interval 6.5 to 8.5	6.2 fold rise Interval 5.5 to 7.1
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 11A	14.5 fold rise Interval 12.2 to 17.1	7.3 fold rise Interval 6.2 to 8.5
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 12F	69.1 fold rise Interval 58.9 to 81.1	38.2 fold rise Interval 32.2 to 45.3
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 15B	25.9 fold rise Interval 21.7 to 31.0	11.8 fold rise Interval 10.0 to 14.0
OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 22F	41.1 fold rise Interval 33.4 to 50.5	23.1 fold rise Interval 19.2 to 27.9

SECONDARY outcome

Timeframe: From before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified serotype.

The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or 13vPnC for the 13 matching serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were summarized.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=688 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=689 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 3	57.6 percentage of participants Interval 53.8 to 61.4	59.4 percentage of participants Interval 55.5 to 63.1
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 4	80.1 percentage of participants Interval 76.8 to 83.1	79.6 percentage of participants Interval 76.3 to 82.6
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 5	54.9 percentage of participants Interval 51.1 to 58.7	59.6 percentage of participants Interval 55.8 to 63.3
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6A	78.9 percentage of participants Interval 75.6 to 81.9	77.6 percentage of participants Interval 74.3 to 80.7
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6B	71.2 percentage of participants Interval 67.5 to 74.7	70.6 percentage of participants Interval 66.9 to 74.2
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 7F	55.7 percentage of participants Interval 51.8 to 59.6	61.9 percentage of participants Interval 58.0 to 65.7
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 9V	60.5 percentage of participants Interval 56.6 to 64.3	62.8 percentage of participants Interval 59.0 to 66.5
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 1	72.6 percentage of participants Interval 69.0 to 75.9	74.2 percentage of participants Interval 70.8 to 77.4
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 14	59.5 percentage of participants Interval 55.6 to 63.3	53.4 percentage of participants Interval 49.5 to 57.3
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19A	79.6 percentage of participants Interval 76.3 to 82.5	82.4 percentage of participants Interval 79.3 to 85.2
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 18C	73.3 percentage of participants Interval 69.8 to 76.6	79.1 percentage of participants Interval 75.9 to 82.1
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19F	62.5 percentage of participants Interval 58.7 to 66.1	69.9 percentage of participants Interval 66.3 to 73.4
Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 23F	69.8 percentage of participants Interval 66.2 to 73.2	72.5 percentage of participants Interval 69.0 to 75.8

SECONDARY outcome

Population: Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype): participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or 2 respectively, had no other major PDs. Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified rows

The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or PPSV23 for the 7 additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F were summarized.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=689 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=693 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 8	80.5 percentage of participants Interval 77.3 to 83.4	86.3 percentage of participants Interval 83.5 to 88.8
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 22F	75.5 percentage of participants Interval 71.9 to 78.8	70.8 percentage of participants Interval 67.0 to 74.4
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 10A	70.2 percentage of participants Interval 66.5 to 73.7	56.1 percentage of participants Interval 52.1 to 60.0
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 11A	69.4 percentage of participants Interval 65.5 to 73.2	53.1 percentage of participants Interval 48.8 to 57.3
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 12F	86.9 percentage of participants Interval 84.0 to 89.5	80.7 percentage of participants Interval 77.3 to 83.8
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 15B	73.6 percentage of participants Interval 70.0 to 77.0	59.7 percentage of participants Interval 55.7 to 63.5
Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) Serotype 33F	61.1 percentage of participants Interval 57.2 to 64.9	58.1 percentage of participants Interval 54.1 to 62.0

SECONDARY outcome

Timeframe: 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group

Population: Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number analyzed=participants evaluable for this OM at specified rows.

The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC or 13vPnC for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=688 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=689 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 1	84.3 percentage of participants Interval 81.3 to 86.9	85.6 percentage of participants Interval 82.8 to 88.1
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 3	82.3 percentage of participants Interval 79.2 to 85.1	82.4 percentage of participants Interval 79.3 to 85.2
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 4	91.7 percentage of participants Interval 89.4 to 93.7	92.4 percentage of participants Interval 90.1 to 94.2
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 5	67.6 percentage of participants Interval 63.9 to 71.1	70.7 percentage of participants Interval 67.2 to 74.1
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6A	89.8 percentage of participants Interval 87.3 to 91.9	88.8 percentage of participants Interval 86.2 to 91.1
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 6B	91.5 percentage of participants Interval 89.1 to 93.5	90.2 percentage of participants Interval 87.7 to 92.4
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 7F	98.1 percentage of participants Interval 96.8 to 99.0	98.0 percentage of participants Interval 96.6 to 98.9
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 9V	87.2 percentage of participants Interval 84.5 to 89.6	88.3 percentage of participants Interval 85.6 to 90.6
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 14	92.1 percentage of participants Interval 89.8 to 94.0	88.4 percentage of participants Interval 85.7 to 90.7
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 18C	93.3 percentage of participants Interval 91.2 to 95.1	94.8 percentage of participants Interval 92.8 to 96.3
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19A	95.0 percentage of participants Interval 93.1 to 96.5	96.8 percentage of participants Interval 95.2 to 98.0
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 19F	76.4 percentage of participants Interval 73.0 to 79.5	82.3 percentage of participants Interval 79.2 to 85.1
Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC) Serotype 23F	79.8 percentage of participants Interval 76.6 to 82.7	82.4 percentage of participants Interval 79.3 to 85.2

SECONDARY outcome

Timeframe: 1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group

Population: Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype): participants who were enrolled, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major PDs. Number analyzed=participants evaluable at specified rows.

The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC in the 20vPnC/saline groups or PPSV23 in the 13vPnC/PPSV23 group for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=689 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=693 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 11A	96.9 percentage of participants Interval 95.3 to 98.1	92.3 percentage of participants Interval 90.0 to 94.3
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 15B	90.2 percentage of participants Interval 87.6 to 92.4	80.3 percentage of participants Interval 77.1 to 83.3
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 33F	97.4 percentage of participants Interval 95.9 to 98.5	96.5 percentage of participants Interval 94.8 to 97.8
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 8	95.2 percentage of participants Interval 93.3 to 96.7	96.7 percentage of participants Interval 95.1 to 97.9
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 10A	91.1 percentage of participants Interval 88.7 to 93.2	82.1 percentage of participants Interval 78.9 to 84.9
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 12F	96.9 percentage of participants Interval 95.3 to 98.1	91.7 percentage of participants Interval 89.3 to 93.7
Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) Serotype 22F	96.5 percentage of participants Interval 94.8 to 97.8	93.3 percentage of participants Interval 91.1 to 95.1

SECONDARY outcome

Timeframe: Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group

Population: Safety population included all participants enrolled at Japan sites who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is participants enrolled at Japan sites with any e-diary data reported after PPSV23 or saline.

Reactions within 10 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), and severe (\>10.0 cm). Pain at the injection site was grades as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity). This endpoint was requested by local Japan regulator.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=409 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=413 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Redness-Moderate	0 percentage of participants Interval 0.0 to 0.9	8.2 percentage of participants Interval 5.8 to 11.3
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Swelling-Mild	1.0 percentage of participants Interval 0.3 to 2.5	7.7 percentage of participants Interval 5.4 to 10.8
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Swelling-Severe	0 percentage of participants Interval 0.0 to 0.9	7.0 percentage of participants Interval 4.8 to 9.9
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Pain at the injection site-Any	5.6 percentage of participants Interval 3.6 to 8.3	73.1 percentage of participants Interval 68.6 to 77.3
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Pain at the injection site-Mild	5.6 percentage of participants Interval 3.6 to 8.3	46.0 percentage of participants Interval 41.1 to 50.9
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Pain at the injection site-Severe	0 percentage of participants Interval 0.0 to 0.9	2.7 percentage of participants Interval 1.3 to 4.7
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Redness-Any	1.2 percentage of participants Interval 0.4 to 2.8	17.2 percentage of participants Interval 13.7 to 21.2
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Redness-Mild	1.2 percentage of participants Interval 0.4 to 2.8	3.6 percentage of participants Interval 2.0 to 5.9
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Redness-Severe	0 percentage of participants Interval 0.0 to 0.9	5.3 percentage of participants Interval 3.4 to 8.0
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Swelling-Any	1.0 percentage of participants Interval 0.3 to 2.5	28.3 percentage of participants Interval 24.0 to 32.9
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Swelling-Moderate	0 percentage of participants Interval 0.0 to 0.9	13.6 percentage of participants Interval 10.4 to 17.2
Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Pain at the injection site-Moderate	0 percentage of participants Interval 0.0 to 0.9	24.5 percentage of participants Interval 20.4 to 28.9

SECONDARY outcome

Timeframe: Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group

Events within 7 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method. Fever was categorized as ≥38.0 °C, ≥38.0°C to 38.4°C, \>38.4°C to 38.9°C, \>38.9°C to 40.0°C, and \>40.0°C. Fatigue, headache, muscle pain, and joint pain were grades as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity). This endpoint was requested by local Japan regulator.

Outcome measures

Outcome measures
Measure	20vPnC/Saline n=409 Participants Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 n=413 Participants Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Headache-Mild	4.4 percentage of participants Interval 2.6 to 6.9	8.0 percentage of participants Interval 5.6 to 11.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fever ≥38.0°C	0.2 percentage of participants Interval 0.0 to 1.4	1.7 percentage of participants Interval 0.7 to 3.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fever ≥38.0°C to 38.4°C	0 percentage of participants Interval 0.0 to 0.9	1.5 percentage of participants Interval 0.5 to 3.1
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fever >38.4°C to 38.9°C	0.2 percentage of participants Interval 0.0 to 1.4	0.2 percentage of participants Interval 0.0 to 1.3
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fever >38.9°C to 40.0°C	0 percentage of participants Interval 0.0 to 0.9	0 percentage of participants Interval 0.0 to 0.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fever >40.0°C	0 percentage of participants Interval 0.0 to 0.9	0 percentage of participants Interval 0.0 to 0.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fatigue-Any	9.5 percentage of participants Interval 6.9 to 12.8	22.5 percentage of participants Interval 18.6 to 26.9
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fatigue-Mild	7.8 percentage of participants Interval 5.4 to 10.9	15.7 percentage of participants Interval 12.4 to 19.6
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fatigue-Moderate	1.5 percentage of participants Interval 0.5 to 3.2	6.1 percentage of participants Interval 4.0 to 8.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Fatigue-Severe	0.2 percentage of participants Interval 0.0 to 1.4	0.7 percentage of participants Interval 0.2 to 2.1
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Headache-Any	4.9 percentage of participants Interval 3.0 to 7.5	9.4 percentage of participants Interval 6.8 to 12.7
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Headache-Moderate	0.5 percentage of participants Interval 0.1 to 1.8	1.2 percentage of participants Interval 0.4 to 2.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Muscle pain-Mild	3.7 percentage of participants Interval 2.1 to 6.0	16.5 percentage of participants Interval 13.0 to 20.4
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Muscle pain-Moderate	0.5 percentage of participants Interval 0.1 to 1.8	8.0 percentage of participants Interval 5.6 to 11.0
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Muscle pain-Severe	0 percentage of participants Interval 0.0 to 0.9	1.0 percentage of participants Interval 0.3 to 2.5
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Joint pain-Any	1.7 percentage of participants Interval 0.7 to 3.5	6.1 percentage of participants Interval 4.0 to 8.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Joint pain-Mild	1.5 percentage of participants Interval 0.5 to 3.2	4.4 percentage of participants Interval 2.6 to 6.8
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Joint pain-Moderate	0.2 percentage of participants Interval 0.0 to 1.4	1.5 percentage of participants Interval 0.5 to 3.1
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Joint pain-Severe	0 percentage of participants Interval 0.0 to 0.9	0.2 percentage of participants Interval 0.0 to 1.3
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Headache-Severe	0 percentage of participants Interval 0.0 to 0.9	0.2 percentage of participants Interval 0.0 to 1.3
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites Muscle pain-Any	4.2 percentage of participants Interval 2.4 to 6.6	25.4 percentage of participants Interval 21.3 to 29.9

Adverse Events

20vPnC/Saline (Vaccination 1)

Serious events: 3 serious events

Other events: 448 other events

Deaths: 0 deaths

13vPnC/PPSV23 (Vaccination 1)

Serious events: 4 serious events

Other events: 439 other events

Deaths: 0 deaths

20vPnC/Saline (Vaccination 2)

Serious events: 4 serious events

Other events: 78 other events

Deaths: 0 deaths

13vPnC/PPSV23 (Vaccination 2)

Serious events: 3 serious events

Other events: 333 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	20vPnC/Saline (Vaccination 1) n=711 participants at risk Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1)	13vPnC/PPSV23 (Vaccination 1) n=710 participants at risk Participants aged 60 years and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1).	20vPnC/Saline (Vaccination 2) n=695 participants at risk Participants aged 60 years and above received a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).	13vPnC/PPSV23 (Vaccination 2) n=699 participants at risk Participants aged 60 years and above received a single dose of 0.5mL PPSV23 intramuscularly at Vaccination 2 (28 to 42 Days after Vaccination 1).
General disorders Fatigue (FATIGUE)	20.7% 147/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	23.0% 163/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	5.6% 39/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	13.3% 93/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
General disorders Injection site erythema (REDNESS)	12.4% 88/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	9.7% 69/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	0.72% 5/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	10.2% 71/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
General disorders Injection site pain (PAIN)	52.2% 371/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	50.7% 360/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	3.3% 23/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	43.2% 302/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
General disorders Injection site swelling (SWELLING)	10.4% 74/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	7.5% 53/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	0.58% 4/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	16.7% 117/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	6.8% 48/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	7.9% 56/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	0.00% 0/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	0.00% 0/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	17.6% 125/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	17.9% 127/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	2.4% 17/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	15.0% 105/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.
Nervous system disorders Headache (HEADACHE)	9.1% 65/711 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	11.0% 78/710 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	2.9% 20/695 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.	5.6% 39/699 • SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only. Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.

Additional Information

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