Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04526574
• Collaborator: (none)
• Enrollment: 1,796
• Locations: 63
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site: 28.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Other: Saline; Biological: Influenza vaccine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1796 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS ≥65 YEARS OF AGE
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Jun 29, 2021
• Actual Study Completion Date: Jun 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coadministration Group Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.	Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Other: Saline; Normal saline for injection; Biological: Influenza vaccine; Seasonal inactivated influenza vaccine (SIIV)
Active Comparator: Separate Administration Group Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.	Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Other: Saline; Normal saline for injection; Biological: Influenza vaccine; Seasonal inactivated influenza vaccine (SIIV)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC [Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group]

   Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants 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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.

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

   Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

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

   An AE was defined as 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.

4. Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination [From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)]

   An SAE was defined as any untoward medical occurrence that, 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 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. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

5. Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination [Up to 6 months after last Vaccination (i.e. up to 7 months)]

   An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

6. Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC [1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group).]

   OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 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

7. Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV [At 1 month after Vaccination 1 with SIIV]

   HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.

Secondary Outcome Measures

1. Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC [Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)]

   OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

2. Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC [Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)]

   OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.

3. Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV [Before Vaccination 1 to 1 month after Vaccination 1 with SIIV]

   HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female participants ≥65 years of age at the time of consent

• Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease

• Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion Criteria:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)

• Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.

• Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study

• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alliance for Multispecialty Research, LLC	Mobile	Alabama	United States	36608
2	East Valley Gastroenterology and Hepatology Associates	Chandler	Arizona	United States	85224
3	Hope Research Institute	Phoenix	Arizona	United States	85018
4	Paradigm Clinical Research Center	Redding	California	United States	96001
5	Artemis Institute for Clinical Research	San Diego	California	United States	92103
6	California Research Foundation	San Diego	California	United States	92123-1881
7	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
8	Alliance for Multispecialty Research, LLC - Miami	Coral Gables	Florida	United States	33134
9	Nature Coast Clinical Research	Crystal River	Florida	United States	34429
10	Indago Research and Health Center, Inc.	Hialeah	Florida	United States	33012
11	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
12	Lakes Research	Miami Lakes	Florida	United States	33014
13	Suncoast Research Group, LLC	Miami	Florida	United States	33135
14	Alpha Science Research, LLC	Miami	Florida	United States	33186
15	Clinical Neuroscience Solutions, Inc	Orlando	Florida	United States	32801
16	Meridian Clinical Research, LLC	Savannah	Georgia	United States	31406
17	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
18	Advanced Clinical Research	Meridian	Idaho	United States	83642
19	Alliance for Multispecialty Research, LLC	El Dorado	Kansas	United States	67042
20	Alliance for Multispecialty Research, LLC	Wichita	Kansas	United States	67205
21	Alliance for Multispecialty Research, LLC	Wichita	Kansas	United States	67207
22	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana	United States	70119
23	Centennial Medical Group	Elkridge	Maryland	United States	21075
24	Meridian Clinical Research, LLC	Rockville	Maryland	United States	20854
25	Sundance Clinical Research, LLC	Saint Louis	Missouri	United States	63141
26	Meridian Clinical Research	Norfolk	Nebraska	United States	68701
27	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
28	Meridian Clinical Research, LLC	Binghamton	New York	United States	13901
29	Meridian Clinical Research, LLC	Endwell	New York	United States	13760
30	PMG Research of Charlotte, LLC	Charlotte	North Carolina	United States	28209
31	PharmQuest	Greensboro	North Carolina	United States	27408
32	PMG Research of Hickory, LLC	Hickory	North Carolina	United States	28601
33	Accellacare - Raleigh	Raleigh	North Carolina	United States	27609
34	M3 Wake Research, Inc.	Raleigh	North Carolina	United States	27612
35	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina	United States	27804
36	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
37	Lillestol Research LLC	Fargo	North Dakota	United States	58104
38	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
39	Meridian Clinical Research	Cincinnati	Ohio	United States	45219
40	Velocity Clinical Research, Inc.	Cleveland	Ohio	United States	44122
41	Prestige Clinical Research	Franklin	Ohio	United States	45005
42	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
43	Omega Medical Research	Warwick	Rhode Island	United States	02886
44	Main Street Physician's Care	Little River	South Carolina	United States	29566
45	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
46	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee	United States	37620
47	Clinical Research Associates, Inc.	Nashville	Tennessee	United States	37203
48	Benchmark Research	Austin	Texas	United States	78705
49	Velocity Clinical Research, Austin	Cedar Park	Texas	United States	78613
50	Benchmark Research	Fort Worth	Texas	United States	76135
51	Texas Health Resource	Fort Worth	Texas	United States	76135
52	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
53	Wellness Clinical Research	McKinney	Texas	United States	75071
54	LinQ Research, LLC	Pearland	Texas	United States	77584
55	Diagnostics Research Group	San Antonio	Texas	United States	78229
56	Martin Diagnostic Clinic	Tomball	Texas	United States	77375
57	J. Lewis Research Inc. / Foothill Family Clinic Draper	Draper	Utah	United States	84020
58	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	United States	84109
59	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
60	J. Lewis Research, Inc / Jordan River Family Medicine	South Jordan	Utah	United States	84095
61	Alliance for Multispecialty Research - Norfolk	Norfolk	Virginia	United States	23502
62	National Clinical Research, Inc	Richmond	Virginia	United States	23294
63	Allegiance Research Specialists, LLC	Wauwatosa	Wisconsin	United States	53226

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jun 15, 2020
• Statistical Analysis Plan - Oct 27, 2020

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: NCT04526574
• Other Study ID Numbers: B7471004
• First Posted: Aug 26, 2020
• Last Update Posted: Jul 8, 2022
• Last Verified: Jun 1, 2022

• 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; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Pre-assignment Detail	A total of 1796 participants were enrolled in the study and assigned to a study treatment.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid along with 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Period Title: Overall Study
STARTED	898	898
Vaccination 1	895	896
Vaccination 2	874	878
COMPLETED	862	865
NOT COMPLETED	36	33

Baseline Characteristics

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration	Total
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	Total of all reporting groups
Overall Participants	895	896	1791
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	72.1 (5.49)	71.9 (5.48)	72.0 (5.49)
Sex: Female, Male (Count of Participants)
Female	483 54%	496 55.4%	979 54.7%
Male	412 46%	400 44.6%	812 45.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	92 10.3%	77 8.6%	169 9.4%
Not Hispanic or Latino	793 88.6%	813 90.7%	1606 89.7%
Unknown or Not Reported	10 1.1%	6 0.7%	16 0.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.1%	2 0.2%	3 0.2%
Asian	7 0.8%	15 1.7%	22 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	58 6.5%	65 7.3%	123 6.9%
White	816 91.2%	807 90.1%	1623 90.6%
More than one race	10 1.1%	3 0.3%	13 0.7%
Unknown or Not Reported	3 0.3%	4 0.4%	7 0.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC
Description	Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants 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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Time Frame	Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants with any e-diary data reported after vaccination with 20vPnC.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	876	855
Redness: Any	6.3 0.7%	7.4 0.8%
Redness: Mild	4.0 0.4%	3.3 0.4%
Redness: Moderate	2.1 0.2%	3.3 0.4%
Redness: Severe	0.2 0%	0.8 0.1%
Swelling: Any	8.2 0.9%	7.8 0.9%
Swelling: Mild	5.0 0.6%	4.4 0.5%
Swelling: Moderate	2.9 0.3%	3.3 0.4%
Swelling: Severe	0.3 0%	0.1 0%
Pain at the injection site: Any	48.9 5.5%	51.5 5.7%
Pain at the injection site: Mild	41.0 4.6%	42.9 4.8%
Pain at the injection site: Moderate	7.6 0.8%	8.4 0.9%
Pain at the injection site: Severe	0.2 0%	0.1 0%

2. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine
Description	Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame	Within 7 days after each vaccination

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'N' signifies number of participants with any e-diary data reported after the vaccination at the specified visit.

Arm/Group Title	20vPnC Coadministered With SIIV	Separate SIIV Administration	Saline Only	Separate 20vPnC
Arm/Group Description	Participants in the (SIIV+20vPnC)/Saline (Coadministration) group received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1).	Participants in the (SIIV+Saline)/20vPnC group received single dose of SIIV injected intramuscularly into the left deltoid (Vaccination 1).	Participants in the (SIIV+20vPnC)/Saline: Coadministration group received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1.	Participants in the (SIIV+Saline)/20vPnC group received single dose of 0.5 ml of 20vPnC injected intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1.
Measure Participants	877	883	853	855
Fever: >=38.0 degree C	1.5 0.2%	0.6 0.1%	0.7 0%	0.5 NaN
Fever: >=38.0 degree C to 38.4 degree C	0.9 0.1%	0.5 0.1%	0.6 0%	0.4 NaN
Fever: >38.4 degree C to 38.9 degree C	0.5 0.1%	0.1 0%	0 0%	0.1 NaN
Fever: >38.9 degree C to 40.0 degree C	0.1 0%	0 0%	0.1 0%	0 NaN
Fever: >40.0 degree C	0 0%	0 0%	0 0%	0 NaN
Fatigue: Any	33.2 3.7%	22.8 2.5%	13.2 0.7%	20.1 NaN
Fatigue: Mild	20.0 2.2%	12.6 1.4%	8.0 0.4%	10.8 NaN
Fatigue: Moderate	12.3 1.4%	9.6 1.1%	4.9 0.3%	8.4 NaN
Fatigue: Severe	0.9 0.1%	0.6 0.1%	0.4 0%	0.9 NaN
Headache: Any	21.9 2.4%	18.0 2%	12.0 0.7%	15.3 NaN
Headache: Mild	16.2 1.8%	13.0 1.5%	9.1 0.5%	10.9 NaN
Headache: Moderate	5.5 0.6%	5.0 0.6%	2.6 0.1%	4.1 NaN
Headache: Severe	0.2 0%	0 0%	0.2 0%	0.4 NaN
Muscle Pain: Any	19.7 2.2%	13.7 1.5%	8.2 0.5%	14.2 NaN
Muscle Pain: Mild	11.1 1.2%	8.9 1%	4.2 0.2%	8.8 NaN
Muscle Pain: Moderate	8.0 0.9%	4.5 0.5%	3.9 0.2%	5.4 NaN
Muscle Pain: Severe	0.7 0.1%	0.2 0%	0.1 0%	0 NaN
Joint Pain: Any	13.3 1.5%	12.5 1.4%	7.7 0.4%	10.3 NaN
Joint Pain: Mild	6.6 0.7%	6.6 0.7%	2.7 0.2%	6.4 NaN
Joint Pain: Moderate	6.5 0.7%	5.7 0.6%	4.8 0.3%	3.6 NaN
Joint Pain: Severe	0.2 0%	0.2 0%	0.2 0%	0.2 NaN

3. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine
Description	An AE was defined as 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.
Time Frame	Within 1 month after each vaccination

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'Overall number of participants analyzed' (N) is the number of participants included in the safety population who received the specified vaccination.

Arm/Group Title	20vPnC Coadministered With SIIV	Separate SIIV Administration	Saline Only	Separate 20vPnC
Arm/Group Description	Participants in the (SIIV+20vPnC)/Saline (Coadministration) group received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1).	Participants in the (SIIV+Saline)/20vPnC group received single dose of SIIV injected intramuscularly into the left deltoid (Vaccination 1).	Participants in the (SIIV+20vPnC)/Saline: Coadministration group received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1.	Participants in the (SIIV+Saline)/20vPnC group received single dose of 0.5 ml of 20vPnC injected intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1.
Measure Participants	895	896	874	878
Number (95% Confidence Interval) [Percentage of participants]	9.1 1%	8.0 0.9%	6.3 0.4%	8.7 NaN

4. Primary Outcome

Title	Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination
Description	An SAE was defined as any untoward medical occurrence that, 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 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. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame	From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	895	896
Number (95% Confidence Interval) [Percentage of participants]	3.7 0.4%	3.7 0.4%

5. Primary Outcome

Title	Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination
Description	An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame	Up to 6 months after last Vaccination (i.e. up to 7 months)

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	895	896
Number (95% Confidence Interval) [Percentage of participants]	3.8 0.4%	3.1 0.3%

6. Primary Outcome

Title	Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC
Description	OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 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
Time Frame	1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group).

Outcome Measure Data

Analysis Population Description

Evaluable pneumococcal immunogenicity(EPI) population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC; with least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; had no other major protocol deviations as determined by clinician. Here,'N':number of participants in evaluable immunogenicity population and 'number analyzed': number of evaluable participants with a valid OPA titer for the specified serotype.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	854	834
Serotype 1	70	95
Serotype 3	38	46
Serotype 4	567	639
Serotype 5	71	81
Serotype 6A	753	995
Serotype 6B	855	1050
Serotype 7F	918	1015
Serotype 8	260	323
Serotype 9V	1261	1344
Serotype 10A	1391	1681
Serotype 11A	1032	1453
Serotype 12F	1352	1652
Serotype 14	514	600
Serotype 15B	839	1202
Serotype 18C	825	920
Serotype 19A	467	534
Serotype 19F	241	272
Serotype 22F	2192	2933
Serotype 23F	247	318
Serotype 33F	3047	4259

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 1: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric Mean Ratio (GMR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 3: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.75 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 4: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 5: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.79 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 6A: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 6B: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.71 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 7F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.83 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 8: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 9V: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 10A: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.71 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 11A: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 12F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 14: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.76 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 15B: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 18C: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 19A: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.78 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 19F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 22F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 23F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	Serotype 33F: GMR (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV
Description	HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
Time Frame	At 1 month after Vaccination 1 with SIIV

Outcome Measure Data

Analysis Population Description

Evaluable HAI immunogenicity population: all randomized participants who received assigned vaccinations; had blood collected within 27 to 49 days after SIIV; had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; had no other major protocol deviations as determined by clinician. Here, 'N': number of participants in evaluable HAI immunogenicity population, 'number analyzed': number of evaluable HAI participants with a valid result for the specified HAI strain.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	861	865
A/H1N1	51.9	48.7
A/H3N2	189.8	193.4
B/Victoria	68.1	68.0
B/Phuket	39.4	41.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	A/H1N1: GMRs (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	A/H3N2: GMRs (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	B/Victoria: GMRs (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	(SIIV+20vPnC)/Saline: Coadministration, (SIIV+Saline)/20vPnC: Separate Administration
	Comments	B/Phuket: GMRs (ratio of GMTs [SIIV+20vPnC]/saline to [SIIV+saline]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.
	Type of Statistical Test	Non-Inferiority
	Comments	NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC
Description	OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Time Frame	Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)

Outcome Measure Data

Analysis Population Description

EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants with valid results for both timepoints (before Vaccination 1 and 1 month after 20vPnC), 'number analyzed': participants evaluable for specific serotypes.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	854	834
Serotype 1	32.9 3.7%	42.0 4.7%
Serotype 3	31.1 3.5%	39.7 4.4%
Serotype 4	45.3 5.1%	48.5 5.4%
Serotype 5	28.2 3.2%	32.7 3.6%
Serotype 6A	57.7 6.4%	62.9 7%
Serotype 6B	51.7 5.8%	55.3 6.2%
Serotype 7F	26.5 3%	29.3 3.3%
Serotype 8	52.1 5.8%	53.8 6%
Serotype 9V	41.4 4.6%	43.6 4.9%
Serotype 10A	56.5 6.3%	62.0 6.9%
Serotype 11A	43.5 4.9%	50.6 5.6%
Serotype 12F	60.1 6.7%	63.6 7.1%
Serotype 14	24.8 2.8%	30.3 3.4%
Serotype 15B	56.7 6.3%	60.8 6.8%
Serotype 18C	39.3 4.4%	42.7 4.8%
Serotype 19A	36.0 4%	40.2 4.5%
Serotype 19F	33.9 3.8%	38.6 4.3%
Serotype 22F	68.7 7.7%	72.0 8%
Serotype 23F	49.8 5.6%	55.1 6.1%
Serotype 33F	39.1 4.4%	47.7 5.3%

9. Secondary Outcome

Title	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC
Description	OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
Time Frame	Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group)

Outcome Measure Data

Analysis Population Description

EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants in the EPI, 'number analyzed': participants with valid OPA titers both before vaccination at Visit 1 and 1 month after 20vPnC blood sample collections.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	854	834
Serotype 1	3.0	4.0
Serotype 3	2.5	3.1
Serotype 4	6.2	7.4
Serotype 5	2.4	2.7
Serotype 6A	8.8	11.9
Serotype 6B	6.5	8.4
Serotype 7F	2.6	2.8
Serotype 8	5.8	7.3
Serotype 9V	4.0	4.3
Serotype 10A	8.0	10.1
Serotype 11A	4.4	6.2
Serotype 12F	11.4	14.4
Serotype 14	2.5	3.0
Serotype 15B	11.7	16.4
Serotype 18C	4.6	5.2
Serotype 19A	3.7	4.2
Serotype 19F	3.0	3.3
Serotype 22F	23.6	32.3
Serotype 23F	6.4	8.5
Serotype 33F	3.3	4.8

10. Secondary Outcome

Title	Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV
Description	HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.
Time Frame	Before Vaccination 1 to 1 month after Vaccination 1 with SIIV

Outcome Measure Data

Analysis Population Description

Evaluable HAI immunogenicity population:randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after SIIV;had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; no other major protocol deviations as determined by clinician. 'N': participants analyzed in HAI immunogenicity population, 'number analyzed':participants with valid HAI titers both before vaccination at Visit 1 and 1 month after SIIV blood sample collections.

Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration	(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.	On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
Measure Participants	861	865
A/H1N1	1.8	1.8
A/H3N2	2.0	2.0
B/Victoria	1.7	1.7
B/Phuket	1.4	1.4

Adverse Events

Time Frame	Local reactions(systematic assessment): within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group, Systemic events(systematic assessment): within 7 days after Vaccination 1 for Coadministration group and within 7 days after Vaccination 2 for Separate Administration group, SAEs: from Day 1 up to 6 months after last vaccination(i.e., up to 7 months) and other AEs: up to 1 month after each 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.
Arm/Group Title	(SIIV+20vPnC)/Saline: Coadministration		(SIIV+Saline)/20vPnC: Separate Administration
Arm/Group Description	On Day 1, participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid along with 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.		On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2.
All Cause Mortality
	(SIIV+20vPnC)/Saline: Coadministration		(SIIV+Saline)/20vPnC: Separate Administration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/895 (0.2%)		3/896 (0.3%)
Serious Adverse Events
	(SIIV+20vPnC)/Saline: Coadministration		(SIIV+Saline)/20vPnC: Separate Administration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/895 (3.7%)		33/896 (3.7%)
Blood and lymphatic system disorders
Anaemia	1/895 (0.1%)		0/896 (0%)
Cardiac disorders
Acute left ventricular failure	1/895 (0.1%)		0/896 (0%)
Acute myocardial infarction	0/895 (0%)		1/896 (0.1%)
Atrial fibrillation	2/895 (0.2%)		1/896 (0.1%)
Atrioventricular block complete	2/895 (0.2%)		1/896 (0.1%)
Cardiac failure	0/895 (0%)		1/896 (0.1%)
Cardiac failure congestive	1/895 (0.1%)		1/896 (0.1%)
Cardiogenic shock	1/895 (0.1%)		1/896 (0.1%)
Coronary artery disease	0/895 (0%)		1/896 (0.1%)
Left ventricular failure	0/895 (0%)		1/896 (0.1%)
Myocardial infarction	0/895 (0%)		1/896 (0.1%)
Eye disorders
Retinal detachment	0/895 (0%)		1/896 (0.1%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/895 (0.1%)		0/896 (0%)
Intestinal obstruction	1/895 (0.1%)		0/896 (0%)
Pancreatitis	0/895 (0%)		1/896 (0.1%)
Pancreatitis chronic	0/895 (0%)		1/896 (0.1%)
Small intestinal obstruction	1/895 (0.1%)		0/896 (0%)
Upper gastrointestinal haemorrhage	0/895 (0%)		1/896 (0.1%)
General disorders
Chest pain	2/895 (0.2%)		2/896 (0.2%)
Vascular stent stenosis	0/895 (0%)		1/896 (0.1%)
Hepatobiliary disorders
Cholecystitis acute	0/895 (0%)		1/896 (0.1%)
Cholelithiasis	1/895 (0.1%)		0/896 (0%)
Cholestasis	1/895 (0.1%)		0/896 (0%)
Infections and infestations
COVID-19	1/895 (0.1%)		3/896 (0.3%)
COVID-19 pneumonia	3/895 (0.3%)		1/896 (0.1%)
Cellulitis	1/895 (0.1%)		0/896 (0%)
Liver abscess	1/895 (0.1%)		0/896 (0%)
Osteomyelitis	1/895 (0.1%)		0/896 (0%)
Sepsis	1/895 (0.1%)		0/896 (0%)
Injury, poisoning and procedural complications
Femur fracture	2/895 (0.2%)		0/896 (0%)
Hip fracture	1/895 (0.1%)		0/896 (0%)
Humerus fracture	0/895 (0%)		1/896 (0.1%)
Pelvic fracture	0/895 (0%)		1/896 (0.1%)
Procedural pain	1/895 (0.1%)		0/896 (0%)
Subdural haematoma	1/895 (0.1%)		1/896 (0.1%)
Metabolism and nutrition disorders
Hypoglycaemia	0/895 (0%)		1/896 (0.1%)
Musculoskeletal and connective tissue disorders
Haematoma muscle	0/895 (0%)		1/896 (0.1%)
Osteoarthritis	0/895 (0%)		1/896 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV	0/895 (0%)		1/896 (0.1%)
Endometrial adenocarcinoma	0/895 (0%)		1/896 (0.1%)
Lung adenocarcinoma	0/895 (0%)		1/896 (0.1%)
Lung neoplasm malignant	1/895 (0.1%)		0/896 (0%)
Malignant melanoma in situ	1/895 (0.1%)		0/896 (0%)
Prostate cancer	2/895 (0.2%)		0/896 (0%)
Prostate cancer metastatic	1/895 (0.1%)		0/896 (0%)
Renal cancer	0/895 (0%)		1/896 (0.1%)
Neoplasm	0/895 (0%)		1/896 (0.1%)
Nervous system disorders
Carotid artery stenosis	0/895 (0%)		1/896 (0.1%)
Syncope	0/895 (0%)		2/896 (0.2%)
Renal and urinary disorders
Acute kidney injury	2/895 (0.2%)		1/896 (0.1%)
Nephrolithiasis	1/895 (0.1%)		0/896 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/895 (0%)		1/896 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	3/895 (0.3%)		1/896 (0.1%)
Pulmonary embolism	1/895 (0.1%)		0/896 (0%)
Pulmonary hypertension	0/895 (0%)		1/896 (0.1%)
Pulmonary oedema	0/895 (0%)		1/896 (0.1%)
Respiratory failure	1/895 (0.1%)		0/896 (0%)
Vascular disorders
Aortic stenosis	1/895 (0.1%)		0/896 (0%)
Intermittent claudication	0/895 (0%)		1/896 (0.1%)
Peripheral artery aneurysm	0/895 (0%)		1/896 (0.1%)
Thrombosis	1/895 (0.1%)		0/896 (0%)
Other (Not Including Serious) Adverse Events
	(SIIV+20vPnC)/Saline: Coadministration		(SIIV+Saline)/20vPnC: Separate Administration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	629/895 (70.3%)		644/896 (71.9%)
General disorders
Fatigue (FATIGUE)	332/895 (37.1%)		299/896 (33.4%)
Injection site erythema (REDNESS)	57/895 (6.4%)		67/896 (7.5%)
Injection site pain (PAIN)	440/895 (49.2%)		461/896 (51.5%)
Injection site swelling (SWELLING)	73/895 (8.2%)		76/896 (8.5%)
Pyrexia (FEVER)	17/895 (1.9%)		9/896 (1%)
Infections and infestations
COVID-19	12/895 (1.3%)		18/896 (2%)
Injury, poisoning and procedural complications
Fall	11/895 (1.2%)		12/896 (1.3%)
Investigations
SARS-CoV-2 test positive	14/895 (1.6%)		20/896 (2.2%)
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)	148/895 (16.5%)		155/896 (17.3%)
Myalgia (MUSCLE PAIN)	207/895 (23.1%)		199/896 (22.2%)
Nervous system disorders
Headache (HEADACHE)	241/895 (26.9%)		231/896 (25.8%)

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.