Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03835975
• Collaborator: (none)
• Enrollment: 875
• Locations: 42
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site: 20.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: 13vPnC; Biological: PPSV23; Biological: 20vPnC	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 875 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION
• Actual Study Start Date: Feb 12, 2019
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 13vPnC Pneumococcal conjugate vaccine	Biological: 13vPnC; Pneumococcal conjugate vaccine
Active Comparator: PPSV23 Pneumococcal polysaccharide vaccine	Biological: PPSV23; Pneumococcal polysaccharide vaccine
Experimental: 20vPnC Pneumococcal conjugate vaccine	Biological: 20vPnC; Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Local Reactions Within 10 Days After Vaccination [Within 10 days after vaccination]

   Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

2. Percentage of Participants With Systemic Events Within 7 Days After Vaccination [Within 7 days after vaccination]

   Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).

3. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination [Within 1 month after vaccination]

   An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

4. Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination [Within 6 months after vaccination]

   An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.

5. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination [Within 6 months after vaccination]

   An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.

6. Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination [1 month after vaccination]

   OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.

Secondary Outcome Measures

1. Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination [From before vaccination to 1 month after vaccination]

   OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

2. Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination [From before vaccination to 1 month after vaccination]

   Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

3. Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination [1 month after vaccination]

   The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

1. Male or female adults 65 years of age or greater.

2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.

3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.

4. Male or female adults who meet 1 of the following:

5. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A).

6. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).

7. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

1. Serious chronic disorder 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 that, in the investigator's opinion, excludes the subject from participating in the study.

2. History of microbiologically proven invasive disease caused by S pneumoniae.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	East Valley Gastroenterology and Hepatology Associates	Chandler	Arizona	United States	85224
3	The Pain Center of Arizona	Peoria	Arizona	United States	85381
4	HOPE Research Institute	Phoenix	Arizona	United States	85018
5	The Pain Center of Arizona	Phoenix	Arizona	United States	85018
6	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
7	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
8	Clinical Research Consulting, LLC	Milford	Connecticut	United States	06460
9	Optimal Research, LLC	Melbourne	Florida	United States	32934
10	Synexus Clinical Research US, Inc	The Villages	Florida	United States	32162
11	Meridian Clinical Research, LLC	Savannah	Georgia	United States	31406
12	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
13	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
14	Heartland Research Associates, LLC	Wichita	Kansas	United States	67205
15	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
16	MedPharmics, LLC	Metairie	Louisiana	United States	70006
17	Meridian Clinical Research, LLC	Rockville	Maryland	United States	20854
18	Meridian Clinical Research, LLC	Norfolk	Nebraska	United States	68701
19	MedPharmics, LLC	Albuquerque	New Mexico	United States	87102
20	Carolina Institute for Clinical Research	Fayetteville	North Carolina	United States	28304
21	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
22	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
23	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45246
24	Prestige Clinical Research	Franklin	Ohio	United States	45005
25	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
26	Kaiser Permanente Center For Health Research	Portland	Oregon	United States	97227
27	Columbia Research Group, Inc.	Portland	Oregon	United States	97239
28	Medical Research South, LLC	Goose Creek	South Carolina	United States	29445
29	Ventavia Research Group	Keller	Texas	United States	76248
30	J. Lewis Research Inc. / Foothill Family Clinic Draper	Draper	Utah	United States	84020
31	J. Lewis Research, Inc. - Foothill Family Clinic	Salt Lake City	Utah	United States	84109
32	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
33	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah	United States	84095
34	Kaiser Permanente Washington Health Research Institute	Seattle	Washington	United States	98101
35	PharmaSite	Malmo	Skane	Sweden	21152
36	Ladulaas Kliniska Studier	Boras		Sweden	50630
37	Infektionskliniken	Eskilstuna		Sweden	63188
38	CTC Gothia Forum	Goteborg		Sweden	413 45
39	ProbarE i Lund	Lund		Sweden	22222
40	Avdelningen for Kliniska Provningar	Orebro		Sweden	703 62
41	Karolinska Trial Alliance, KTA Prim	Stockholm		Sweden	11361
42	Akardo Med Site	Stockholm		Sweden	11446

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Statistical Analysis Plan - Mar 23, 2020
• Study Protocol - Feb 11, 2019

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03835975
• Other Study ID Numbers: B7471006; 2018-004278-91
• First Posted: Feb 11, 2019
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumococcal Infections; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Period Title: Overall Study
STARTED	253	122	248	127	125
Vaccinated	253	122	246	127	125
Safety Population	253	122	246	127	125
Evaluable Immunogenicity Population (for 20vPnC Cohorts)	247	0	243	0	121
COMPLETED	250	119	245	126	125
NOT COMPLETED	3	3	3	1	0

Baseline Characteristics

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC	Total
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Total of all reporting groups
Overall Participants	253	122	248	127	125	875
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.6 (3.88)	70.2 (4.09)	70.7 (5.70)	70.6 (5.73)	70.8 (4.26)	70.3 (4.84)
Sex: Female, Male (Count of Participants)
Female	140 55.3%	64 52.5%	140 56.5%	68 53.5%	65 52%	477 54.5%
Male	113 44.7%	58 47.5%	108 43.5%	59 46.5%	60 48%	398 45.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 1.6%	3 2.5%	6 2.4%	1 0.8%	2 1.6%	16 1.8%
Not Hispanic or Latino	247 97.6%	117 95.9%	233 94%	122 96.1%	113 90.4%	832 95.1%
Unknown or Not Reported	2 0.8%	2 1.6%	9 3.6%	4 3.1%	10 8%	27 3.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	0 0%	1 0.4%	0 0%	0 0%	2 0.2%
Asian	1 0.4%	2 1.6%	0 0%	2 1.6%	0 0%	5 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.8%	1 0.4%	1 0.8%	0 0%	3 0.3%
Black or African American	15 5.9%	8 6.6%	14 5.6%	6 4.7%	4 3.2%	47 5.4%
White	236 93.3%	110 90.2%	228 91.9%	118 92.9%	117 93.6%	809 92.5%
More than one race	0 0%	0 0%	1 0.4%	0 0%	3 2.4%	4 0.5%
Unknown or Not Reported	0 0%	1 0.8%	3 1.2%	0 0%	1 0.8%	5 0.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Description	Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time Frame	Within 10 days after vaccination

Outcome Measure Data

Analysis Population Description

The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population.

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	253	121	245	126	125
Redness: Any	7.9 3.1%	2.5 2%	8.6 3.5%	12.7 10%	4.8 3.8%
Redness: Mild	3.6 1.4%	1.7 1.4%	2.9 1.2%	4.8 3.8%	1.6 1.3%
Redness: Moderate	3.2 1.3%	0.8 0.7%	5.3 2.1%	7.1 5.6%	3.2 2.6%
Redness: Severe	1.2 0.5%	0 0%	0.4 0.2%	0.8 0.6%	0 0%
Swelling: Any	9.9 3.9%	6.6 5.4%	9.4 3.8%	14.3 11.3%	4.0 3.2%
Swelling: Mild	5.1 2%	6.6 5.4%	5.7 2.3%	6.3 5%	1.6 1.3%
Swelling: Moderate	3.6 1.4%	0 0%	3.7 1.5%	7.1 5.6%	2.4 1.9%
Swelling: Severe	1.2 0.5%	0 0%	0 0%	0.8 0.6%	0 0%
Pain at the injection site: Any	50.2 19.8%	43.0 35.2%	61.2 24.7%	56.3 44.3%	52.8 42.2%
Pain at the injection site: Mild	45.8 18.1%	38.8 31.8%	54.7 22.1%	40.5 31.9%	47.2 37.8%
Pain at the injection site: Moderate	4.3 1.7%	3.3 2.7%	6.1 2.5%	14.3 11.3%	5.6 4.5%
Pain at the injection site: Severe	0 0%	0.8 0.7%	0.4 0.2%	1.6 1.3%	0 0%

2. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Description	Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Time Frame	Within 7 days after vaccination

Outcome Measure Data

Analysis Population Description

The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population.

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	253	121	245	126	125
Fever: >=38.0 degree C	0.8 0.3%	0 0%	0 0%	1.6 1.3%	0 0%
Fever: >=38.0 degree C to 38.4 degree C	0.8 0.3%	0 0%	0 0%	0.8 0.6%	0 0%
Fever: >38.4 degree C to 38.9 degree C	0 0%	0 0%	0 0%	0.8 0.6%	0 0%
Fever: >38.9 degree C to 40.0 degree C	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: >40.0 degree C	0 0%	0 0%	0 0%	0 0%	0 0%
Fatigue: Any	28.9 11.4%	22.3 18.3%	31.0 12.5%	33.3 26.2%	32.8 26.2%
Fatigue: Mild	17.8 7%	9.9 8.1%	19.6 7.9%	19.8 15.6%	19.2 15.4%
Fatigue: Moderate	11.1 4.4%	9.9 8.1%	10.2 4.1%	13.5 10.6%	12.0 9.6%
Fatigue: Severe	0 0%	2.5 2%	1.2 0.5%	0 0%	1.6 1.3%
Headache: Any	17.8 7%	18.2 14.9%	13.5 5.4%	21.4 16.9%	19.2 15.4%
Headache: Mild	12.6 5%	12.4 10.2%	9.8 4%	20.6 16.2%	12.8 10.2%
Headache: Moderate	4.7 1.9%	5.8 4.8%	3.7 1.5%	0.8 0.6%	5.6 4.5%
Headache: Severe	0.4 0.2%	0 0%	0 0%	0 0%	0.8 0.6%
Muscle Pain: Any	32.0 12.6%	31.4 25.7%	33.9 13.7%	46.0 36.2%	37.6 30.1%
Muscle Pain: Mild	26.1 10.3%	24.0 19.7%	25.3 10.2%	31.7 25%	28.0 22.4%
Muscle Pain: Moderate	5.5 2.2%	5.0 4.1%	8.6 3.5%	11.9 9.4%	8.8 7%
Muscle Pain: Severe	0.4 0.2%	2.5 2%	0 0%	2.4 1.9%	0.8 0.6%
Joint Pain: Any	6.7 2.6%	10.7 8.8%	11.8 4.8%	15.9 12.5%	16.8 13.4%
Joint Pain: Mild	4.7 1.9%	5.0 4.1%	7.8 3.1%	10.3 8.1%	12.8 10.2%
Joint Pain: Moderate	2.0 0.8%	5.0 4.1%	4.1 1.7%	5.6 4.4%	4.0 3.2%
Joint Pain: Severe	0 0%	0.8 0.7%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Description	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time Frame	Within 1 month after vaccination

Outcome Measure Data

Analysis Population Description

The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	253	122	246	127	125
Number (95% Confidence Interval) [percentage of participants]	7.5 3%	9.0 7.4%	4.9 2%	11.0 8.7%	10.4 8.3%

4. Primary Outcome

Title	Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Description	An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Time Frame	Within 6 months after vaccination

Outcome Measure Data

Analysis Population Description

The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	253	122	246	127	125
Number (95% Confidence Interval) [percentage of participants]	0.8 0.3%	1.6 1.3%	2.4 1%	1.6 1.3%	1.6 1.3%

5. Primary Outcome

Title	Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Description	An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Time Frame	Within 6 months after vaccination

Outcome Measure Data

Analysis Population Description

The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

Arm/Group Title	Cohort A: 20vPnC	Cohort A: 13vPnC	Cohort B: 20vPnC	Cohort B: PPSV23	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	253	122	246	127	125
Number (95% Confidence Interval) [percentage of participants]	2.0 0.8%	0.8 0.7%	2.8 1.1%	2.4 1.9%	4.0 3.2%

6. Primary Outcome

Title	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Description	OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
Time Frame	1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotypes.

Arm/Group Title	Cohort A: 20vPnC	Cohort B: 20vPnC	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	247	243	121
Serotype 1	50.8	115.3	82.1
Serotype 3	31.1	54.3	39.3
Serotype 4	149.9	334.9	193.7
Serotype 5	62.8	87.3	83.5
Serotype 6A	748.7	1080.9	1085.3
Serotype 6B	727.3	1159.4	1033.3
Serotype 7F	378.1	555.4	345.8
Serotype 9V	550.3	1085.0	723.4
Serotype 14	391.2	664.9	580.5
Serotype 18C	551.9	845.9	621.2
Serotype 19A	238.6	365.1	340.6
Serotype 19F	159.0	242.3	217.7
Serotype 23F	151.6	450.2	292.6
Serotype 8	211.9	602.9	293.8
Serotype 10A	1012.1	2005.4	1580.3
Serotype 11A	1473.2	1908.2	1566.6
Serotype 12F	1054.5	1763.4	1401.2
Serotype 15B	647.1	1479.5	1066.9
Serotype 22F	1772.8	4156.5	2717.8
Serotype 33F	2026.2	3174.9	2182.9

7. Secondary Outcome

Title	Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Description	OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame	From before vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population was analyzed. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number analyzed= number of participants evaluable with OPA titers available at both time points for each serotype.

Arm/Group Title	Cohort A: 20vPnC	Cohort B: 20vPnC	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	247	243	121
Serotype 1	2.2	3.4	2.0
Serotype 3	2.4	3.5	1.9
Serotype 4	4.9	5.0	2.4
Serotype 5	2.3	2.3	1.8
Serotype 6A	12.6	8.3	6.5
Serotype 6B	6.6	6.7	4.0
Serotype 7F	2.3	2.6	1.6
Serotype 9V	2.4	3.1	2.1
Serotype 14	1.8	2.3	1.7
Serotype 18C	3.2	3.9	2.2
Serotype 19A	2.9	2.9	1.9
Serotype 19F	2.6	2.7	1.9
Serotype 23F	6.6	9.3	4.5
Serotype 8	3.6	22.5	2.1
Serotype 10A	4.5	14.4	4.4
Serotype 11A	2.5	6.7	3.1
Serotype 12F	7.2	31.7	3.8
Serotype 15B	4.3	18.9	4.8
Serotype 22F	11.1	66.9	9.8
Serotype 33F	1.8	5.4	1.8

8. Secondary Outcome

Title	Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Description	Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame	From before vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.

Arm/Group Title	Cohort A: 20vPnC	Cohort B: 20vPnC	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	247	243	121
Serotype 1	22.9 9.1%	40.3 33%	20.8 8.4%
Serotype 3	29.6 11.7%	41.3 33.9%	18.5 7.5%
Serotype 4	41.1 16.2%	41.3 33.9%	25.2 10.2%
Serotype 5	25.7 10.2%	27.2 22.3%	15.8 6.4%
Serotype 6A	61.5 24.3%	56.4 46.2%	44.9 18.1%
Serotype 6B	53.4 21.1%	55.0 45.1%	35.3 14.2%
Serotype 7F	26.2 10.4%	30.3 24.8%	14.3 5.8%
Serotype 9V	28.3 11.2%	36.0 29.5%	20.2 8.1%
Serotype 14	15.7 6.2%	24.9 20.4%	16.0 6.5%
Serotype 18C	29.4 11.6%	38.3 31.4%	17.6 7.1%
Serotype 19A	29.7 11.7%	29.3 24%	15.4 6.2%
Serotype 19F	29.2 11.5%	32.8 26.9%	16.9 6.8%
Serotype 23F	49.6 19.6%	58.7 48.1%	42.9 17.3%
Serotype 8	39.9 15.8%	72.6 59.5%	30.7 12.4%
Serotype 10A	45.5 18%	70.9 58.1%	44.0 17.7%
Serotype 11A	30.4 12%	54.6 44.8%	35.2 14.2%
Serotype 12F	51.4 20.3%	76.5 62.7%	40.8 16.5%
Serotype 15B	37.4 14.8%	66.3 54.3%	38.4 15.5%
Serotype 22F	57.0 22.5%	83.2 68.2%	54.8 22.1%
Serotype 33F	18.7 7.4%	53.6 43.9%	19.2 7.7%

9. Secondary Outcome

Title	Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Description	The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame	1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.

Arm/Group Title	Cohort A: 20vPnC	Cohort B: 20vPnC	Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.	Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.	Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
Measure Participants	247	243	121
Serotype 1	65.4 25.8%	87.7 71.9%	77.5 31.3%
Serotype 3	76.1 30.1%	90.5 74.2%	87.4 35.2%
Serotype 4	76.7 30.3%	91.7 75.2%	87.1 35.1%
Serotype 5	64.8 25.6%	74.9 61.4%	72.5 29.2%
Serotype 6A	84.3 33.3%	93.8 76.9%	90.9 36.7%
Serotype 6B	86.8 34.3%	93.8 76.9%	91.7 37%
Serotype 7F	74.2 29.3%	84.8 69.5%	79.2 31.9%
Serotype 9V	76.8 30.4%	89.5 73.4%	85.5 34.5%
Serotype 14	85.8 33.9%	95.0 77.9%	93.3 37.6%
Serotype 18C	91.8 36.3%	96.3 78.9%	95.8 38.6%
Serotype 19A	93.8 37.1%	95.9 78.6%	98.3 39.6%
Serotype 19F	71.7 28.3%	84.3 69.1%	84.7 34.2%
Serotype 23F	76.3 30.2%	93.8 76.9%	87.5 35.3%
Serotype 8	85.2 33.7%	94.7 77.6%	90.8 36.6%
Serotype 10A	92.2 36.4%	95.7 78.4%	96.4 38.9%
Serotype 11A	91.2 36%	94.7 77.6%	89.2 36%
Serotype 12F	87.9 34.7%	93.0 76.2%	91.8 37%
Serotype 15B	84.9 33.6%	91.0 74.6%	90.0 36.3%
Serotype 22F	94.0 37.2%	99.0 81.1%	98.1 39.6%
Serotype 33F	88.9 35.1%	91.8 75.2%	87.4 35.2%

Adverse Events

Time Frame	Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Adverse Event Reporting Description	Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
Arm/Group Title	Cohort A: 20vPnC		Cohort A: 13vPnC		Cohort B: 20vPnC		Cohort B: PPSV23		Cohort C: 20vPnC
Arm/Group Description	Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.		Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.		Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.		Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.		Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
All Cause Mortality
	Cohort A: 20vPnC		Cohort A: 13vPnC		Cohort B: 20vPnC		Cohort B: PPSV23		Cohort C: 20vPnC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/253 (0%)		0/122 (0%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Serious Adverse Events
	Cohort A: 20vPnC		Cohort A: 13vPnC		Cohort B: 20vPnC		Cohort B: PPSV23		Cohort C: 20vPnC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/253 (0.8%)		2/122 (1.6%)		6/246 (2.4%)		2/127 (1.6%)		2/125 (1.6%)
Cardiac disorders
Acute myocardial infarction	0/253 (0%)		0/122 (0%)		1/246 (0.4%)		0/127 (0%)		0/125 (0%)
Cardiac failure congestive	1/253 (0.4%)		0/122 (0%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Gastrointestinal disorders
Dysphagia	0/253 (0%)		0/122 (0%)		0/246 (0%)		1/127 (0.8%)		0/125 (0%)
Gastrointestinal haemorrhage	0/253 (0%)		0/122 (0%)		1/246 (0.4%)		0/127 (0%)		0/125 (0%)
Hepatobiliary disorders
Cholecystitis	0/253 (0%)		1/122 (0.8%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Infections and infestations
Appendicitis	0/253 (0%)		0/122 (0%)		0/246 (0%)		1/127 (0.8%)		0/125 (0%)
Clostridium difficile colitis	0/253 (0%)		0/122 (0%)		0/246 (0%)		1/127 (0.8%)		0/125 (0%)
Pneumonia	0/253 (0%)		0/122 (0%)		0/246 (0%)		0/127 (0%)		1/125 (0.8%)
Investigations
Blood pressure decreased	0/253 (0%)		1/122 (0.8%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Metabolism and nutrition disorders
Dehydration	0/253 (0%)		0/122 (0%)		0/246 (0%)		1/127 (0.8%)		0/125 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/253 (0%)		0/122 (0%)		0/246 (0%)		0/127 (0%)		1/125 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/253 (0%)		0/122 (0%)		1/246 (0.4%)		0/127 (0%)		0/125 (0%)
Nervous system disorders
Carotid artery stenosis	1/253 (0.4%)		0/122 (0%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Syncope	0/253 (0%)		0/122 (0%)		2/246 (0.8%)		0/127 (0%)		0/125 (0%)
Surgical and medical procedures
Cardiac pacemaker replacement	0/253 (0%)		0/122 (0%)		1/246 (0.4%)		0/127 (0%)		0/125 (0%)
Other (Not Including Serious) Adverse Events
	Cohort A: 20vPnC		Cohort A: 13vPnC		Cohort B: 20vPnC		Cohort B: PPSV23		Cohort C: 20vPnC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	173/253 (68.4%)		69/122 (56.6%)		178/246 (72.4%)		96/127 (75.6%)		86/125 (68.8%)
General disorders
Fatigue (FATIGUE)	73/253 (28.9%)		27/122 (22.1%)		76/246 (30.9%)		42/127 (33.1%)		41/125 (32.8%)
Injection site erythema (REDNESS)	20/253 (7.9%)		3/122 (2.5%)		21/246 (8.5%)		16/127 (12.6%)		6/125 (4.8%)
Injection site pain (PAIN)	127/253 (50.2%)		52/122 (42.6%)		150/246 (61%)		71/127 (55.9%)		66/125 (52.8%)
Injection site swelling (SWELLING)	25/253 (9.9%)		8/122 (6.6%)		23/246 (9.3%)		18/127 (14.2%)		5/125 (4%)
Pyrexia (FEVER)	0/253 (0%)		0/122 (0%)		0/246 (0%)		2/127 (1.6%)		0/125 (0%)
Infections and infestations
Nasopharyngitis	3/253 (1.2%)		1/122 (0.8%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Urinary tract infection	0/253 (0%)		2/122 (1.6%)		0/246 (0%)		0/127 (0%)		0/125 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)	17/253 (6.7%)		13/122 (10.7%)		29/246 (11.8%)		20/127 (15.7%)		21/125 (16.8%)
Myalgia (MUSCLE PAIN)	81/253 (32%)		38/122 (31.1%)		83/246 (33.7%)		58/127 (45.7%)		47/125 (37.6%)
Nervous system disorders
Dizziness	0/253 (0%)		0/122 (0%)		1/246 (0.4%)		2/127 (1.6%)		0/125 (0%)
Headache (HEADACHE)	45/253 (17.8%)		22/122 (18%)		33/246 (13.4%)		27/127 (21.3%)		24/125 (19.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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