Trial Outcomes & Findings for Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age (NCT NCT04526574)

Last Updated: 2022-07-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1796 participants

Primary outcome timeframe

Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group

Results posted on

2022-07-08

Participant Flow

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

Participant milestones

Participant milestones
Measure	(SIIV+20vPnC)/Saline: Coadministration 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.	(SIIV+Saline)/20vPnC: Separate Administration 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.
Overall Study STARTED	898	898
Overall Study Vaccination 1	895	896
Overall Study Vaccination 2	874	878
Overall Study COMPLETED	862	865
Overall Study NOT COMPLETED	36	33

Reasons for withdrawal

Reasons for withdrawal
Measure	(SIIV+20vPnC)/Saline: Coadministration 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.	(SIIV+Saline)/20vPnC: Separate Administration 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.
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	12	9
Overall Study Other	1	2
Overall Study Adverse Event	1	1
Overall Study Death	2	3
Overall Study Lost to Follow-up	9	9
Overall Study No longer meets eligibility criteria	8	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(SIIV+20vPnC)/Saline: Coadministration n=895 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=896 Participants 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 n=1791 Participants Total of all reporting groups
Age, Continuous	72.1 Years STANDARD_DEVIATION 5.49 • n=5 Participants	71.9 Years STANDARD_DEVIATION 5.48 • n=7 Participants	72.0 Years STANDARD_DEVIATION 5.49 • n=5 Participants
Sex: Female, Male Female	483 Participants n=5 Participants	496 Participants n=7 Participants	979 Participants n=5 Participants
Sex: Female, Male Male	412 Participants n=5 Participants	400 Participants n=7 Participants	812 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	92 Participants n=5 Participants	77 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	793 Participants n=5 Participants	813 Participants n=7 Participants	1606 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	58 Participants n=5 Participants	65 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) White	816 Participants n=5 Participants	807 Participants n=7 Participants	1623 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group

Population: 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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=876 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=855 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Redness: Any	6.3 Percentage of participants Interval 4.8 to 8.1	7.4 Percentage of participants Interval 5.7 to 9.3	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Redness: Mild	4.0 Percentage of participants Interval 2.8 to 5.5	3.3 Percentage of participants Interval 2.2 to 4.7	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Redness: Moderate	2.1 Percentage of participants Interval 1.2 to 3.2	3.3 Percentage of participants Interval 2.2 to 4.7	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Redness: Severe	0.2 Percentage of participants Interval 0.0 to 0.8	0.8 Percentage of participants Interval 0.3 to 1.7	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Swelling: Any	8.2 Percentage of participants Interval 6.5 to 10.2	7.8 Percentage of participants Interval 6.1 to 9.8	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Swelling: Mild	5.0 Percentage of participants Interval 3.7 to 6.7	4.4 Percentage of participants Interval 3.2 to 6.0	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Swelling: Moderate	2.9 Percentage of participants Interval 1.9 to 4.2	3.3 Percentage of participants Interval 2.2 to 4.7	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Swelling: Severe	0.3 Percentage of participants Interval 0.1 to 1.0	0.1 Percentage of participants Interval 0.0 to 0.6	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Pain at the injection site: Any	48.9 Percentage of participants Interval 45.5 to 52.2	51.5 Percentage of participants Interval 48.1 to 54.9	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Pain at the injection site: Mild	41.0 Percentage of participants Interval 37.7 to 44.3	42.9 Percentage of participants Interval 39.6 to 46.3	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Pain at the injection site: Moderate	7.6 Percentage of participants Interval 6.0 to 9.6	8.4 Percentage of participants Interval 6.6 to 10.5	—	—
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Pain at the injection site: Severe	0.2 Percentage of participants Interval 0.0 to 0.8	0.1 Percentage of participants Interval 0.0 to 0.6	—	—

PRIMARY outcome

Timeframe: Within 7 days after each vaccination

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=877 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=883 Participants 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.	Saline Only n=853 Participants 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.	Separate 20vPnC n=855 Participants 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.
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fever: >38.4 degree C to 38.9 degree C	0.5 Percentage of participants Interval 0.1 to 1.2	0.1 Percentage of participants Interval 0.0 to 0.6	0 Percentage of participants Interval 0.0 to 0.4	0.1 Percentage of participants Interval 0.0 to 0.6
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fever: >38.9 degree C to 40.0 degree C	0.1 Percentage of participants Interval 0.0 to 0.6	0 Percentage of participants Interval 0.0 to 0.4	0.1 Percentage of participants Interval 0.0 to 0.7	0 Percentage of participants Interval 0.0 to 0.4
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fever: >=38.0 degree C	1.5 Percentage of participants Interval 0.8 to 2.5	0.6 Percentage of participants Interval 0.2 to 1.3	0.7 Percentage of participants Interval 0.3 to 1.5	0.5 Percentage of participants Interval 0.1 to 1.2
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fever: >=38.0 degree C to 38.4 degree C	0.9 Percentage of participants Interval 0.4 to 1.8	0.5 Percentage of participants Interval 0.1 to 1.2	0.6 Percentage of participants Interval 0.2 to 1.4	0.4 Percentage of participants Interval 0.1 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.4
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fatigue: Any	33.2 Percentage of participants Interval 30.1 to 36.4	22.8 Percentage of participants Interval 20.0 to 25.7	13.2 Percentage of participants Interval 11.0 to 15.7	20.1 Percentage of participants Interval 17.5 to 23.0
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fatigue: Mild	20.0 Percentage of participants Interval 17.4 to 22.8	12.6 Percentage of participants Interval 10.5 to 14.9	8.0 Percentage of participants Interval 6.2 to 10.0	10.8 Percentage of participants Interval 8.8 to 13.0
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fatigue: Moderate	12.3 Percentage of participants Interval 10.2 to 14.7	9.6 Percentage of participants Interval 7.8 to 11.8	4.9 Percentage of participants Interval 3.6 to 6.6	8.4 Percentage of participants Interval 6.6 to 10.5
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Fatigue: Severe	0.9 Percentage of participants Interval 0.4 to 1.8	0.6 Percentage of participants Interval 0.2 to 1.3	0.4 Percentage of participants Interval 0.1 to 1.0	0.9 Percentage of participants Interval 0.4 to 1.8
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Headache: Any	21.9 Percentage of participants Interval 19.2 to 24.8	18.0 Percentage of participants Interval 15.5 to 20.7	12.0 Percentage of participants Interval 9.9 to 14.3	15.3 Percentage of participants Interval 13.0 to 17.9
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Headache: Mild	16.2 Percentage of participants Interval 13.8 to 18.8	13.0 Percentage of participants Interval 10.9 to 15.4	9.1 Percentage of participants Interval 7.3 to 11.3	10.9 Percentage of participants Interval 8.9 to 13.2
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Headache: Moderate	5.5 Percentage of participants Interval 4.1 to 7.2	5.0 Percentage of participants Interval 3.6 to 6.6	2.6 Percentage of participants Interval 1.6 to 3.9	4.1 Percentage of participants Interval 2.9 to 5.6
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Headache: Severe	0.2 Percentage of participants Interval 0.0 to 0.8	0 Percentage of participants Interval 0.0 to 0.4	0.2 Percentage of participants Interval 0.0 to 0.8	0.4 Percentage of participants Interval 0.1 to 1.0
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Muscle Pain: Any	19.7 Percentage of participants Interval 17.1 to 22.5	13.7 Percentage of participants Interval 11.5 to 16.1	8.2 Percentage of participants Interval 6.5 to 10.3	14.2 Percentage of participants Interval 11.9 to 16.7
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Muscle Pain: Mild	11.1 Percentage of participants Interval 9.1 to 13.3	8.9 Percentage of participants Interval 7.1 to 11.0	4.2 Percentage of participants Interval 3.0 to 5.8	8.8 Percentage of participants Interval 7.0 to 10.9
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Muscle Pain: Moderate	8.0 Percentage of participants Interval 6.3 to 10.0	4.5 Percentage of participants Interval 3.3 to 6.1	3.9 Percentage of participants Interval 2.7 to 5.4	5.4 Percentage of participants Interval 4.0 to 7.1
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Muscle Pain: Severe	0.7 Percentage of participants Interval 0.3 to 1.5	0.2 Percentage of participants Interval 0.0 to 0.8	0.1 Percentage of participants Interval 0.0 to 0.7	0 Percentage of participants Interval 0.0 to 0.4
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Joint Pain: Any	13.3 Percentage of participants Interval 11.2 to 15.8	12.5 Percentage of participants Interval 10.4 to 14.8	7.7 Percentage of participants Interval 6.0 to 9.7	10.3 Percentage of participants Interval 8.3 to 12.5
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Joint Pain: Mild	6.6 Percentage of participants Interval 5.1 to 8.5	6.6 Percentage of participants Interval 5.0 to 8.4	2.7 Percentage of participants Interval 1.7 to 4.0	6.4 Percentage of participants Interval 4.9 to 8.3
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Joint Pain: Moderate	6.5 Percentage of participants Interval 5.0 to 8.3	5.7 Percentage of participants Interval 4.2 to 7.4	4.8 Percentage of participants Interval 3.5 to 6.5	3.6 Percentage of participants Interval 2.5 to 5.1
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Joint Pain: Severe	0.2 Percentage of participants Interval 0.0 to 0.8	0.2 Percentage of participants Interval 0.0 to 0.8	0.2 Percentage of participants Interval 0.0 to 0.8	0.2 Percentage of participants Interval 0.0 to 0.8

PRIMARY outcome

Timeframe: Within 1 month after each vaccination

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=895 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=896 Participants 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.	Saline Only n=874 Participants 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.	Separate 20vPnC n=878 Participants 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.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine	9.1 Percentage of participants Interval 7.3 to 11.1	8.0 Percentage of participants Interval 6.3 to 10.0	6.3 Percentage of participants Interval 4.8 to 8.1	8.7 Percentage of participants Interval 6.9 to 10.7

PRIMARY outcome

Timeframe: From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months)

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

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=895 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=896 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination	3.7 Percentage of participants Interval 2.6 to 5.1	3.7 Percentage of participants Interval 2.5 to 5.1	—	—

PRIMARY outcome

Timeframe: Up to 6 months after last Vaccination (i.e. up to 7 months)

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

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=895 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=896 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination	3.8 Percentage of participants Interval 2.6 to 5.3	3.1 Percentage of participants Interval 2.1 to 4.5	—	—

PRIMARY outcome

Timeframe: 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).

Population: 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.

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

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=854 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=834 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 1	70 Titer Interval 63.0 to 79.0	95 Titer Interval 85.0 to 107.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 3	38 Titer Interval 34.0 to 41.0	46 Titer Interval 42.0 to 50.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 4	567 Titer Interval 500.0 to 642.0	639 Titer Interval 563.0 to 724.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 5	71 Titer Interval 64.0 to 78.0	81 Titer Interval 73.0 to 89.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 19A	467 Titer Interval 420.0 to 519.0	534 Titer Interval 480.0 to 593.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 19F	241 Titer Interval 215.0 to 270.0	272 Titer Interval 243.0 to 305.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 6A	753 Titer Interval 657.0 to 863.0	995 Titer Interval 868.0 to 1141.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 6B	855 Titer Interval 754.0 to 971.0	1050 Titer Interval 923.0 to 1194.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 7F	918 Titer Interval 846.0 to 996.0	1015 Titer Interval 936.0 to 1101.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 8	260 Titer Interval 228.0 to 296.0	323 Titer Interval 284.0 to 368.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 9V	1261 Titer Interval 1115.0 to 1426.0	1344 Titer Interval 1189.0 to 1519.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 22F	2192 Titer Interval 1850.0 to 2597.0	2933 Titer Interval 2481.0 to 3468.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 10A	1391 Titer Interval 1213.0 to 1595.0	1681 Titer Interval 1468.0 to 1925.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 11A	1032 Titer Interval 886.0 to 1202.0	1453 Titer Interval 1249.0 to 1690.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 12F	1352 Titer Interval 1161.0 to 1574.0	1652 Titer Interval 1415.0 to 1929.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 14	514 Titer Interval 463.0 to 571.0	600 Titer Interval 540.0 to 667.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 15B	839 Titer Interval 695.0 to 1012.0	1202 Titer Interval 997.0 to 1450.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 18C	825 Titer Interval 723.0 to 943.0	920 Titer Interval 805.0 to 1051.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 23F	247 Titer Interval 213.0 to 287.0	318 Titer Interval 273.0 to 369.0	—	—
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC Serotype 33F	3047 Titer Interval 2672.0 to 3475.0	4259 Titer Interval 3737.0 to 4853.0	—	—

PRIMARY outcome

Timeframe: At 1 month after Vaccination 1 with SIIV

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=861 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=865 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV A/H1N1	51.9 Titer Interval 47.6 to 56.6	48.7 Titer Interval 44.7 to 53.0	—	—
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV A/H3N2	189.8 Titer Interval 173.9 to 207.2	193.4 Titer Interval 177.3 to 211.0	—	—
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV B/Victoria	68.1 Titer Interval 63.4 to 73.1	68.0 Titer Interval 63.4 to 73.0	—	—
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV B/Phuket	39.4 Titer Interval 36.3 to 42.6	41.6 Titer Interval 38.4 to 45.0	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=854 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=834 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
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 Serotype 12F	60.1 Percentage of participants Interval 56.6 to 63.6	63.6 Percentage of participants Interval 60.0 to 67.0	—	—
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 Serotype 1	32.9 Percentage of participants Interval 29.7 to 36.2	42.0 Percentage of participants Interval 38.6 to 45.4	—	—
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 Serotype 3	31.1 Percentage of participants Interval 28.0 to 34.4	39.7 Percentage of participants Interval 36.3 to 43.1	—	—
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 Serotype 4	45.3 Percentage of participants Interval 41.9 to 48.8	48.5 Percentage of participants Interval 45.0 to 52.0	—	—
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 Serotype 5	28.2 Percentage of participants Interval 25.2 to 31.4	32.7 Percentage of participants Interval 29.5 to 36.0	—	—
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 Serotype 6A	57.7 Percentage of participants Interval 54.2 to 61.1	62.9 Percentage of participants Interval 59.4 to 66.2	—	—
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 Serotype 6B	51.7 Percentage of participants Interval 48.2 to 55.2	55.3 Percentage of participants Interval 51.8 to 58.8	—	—
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 Serotype 7F	26.5 Percentage of participants Interval 23.5 to 29.6	29.3 Percentage of participants Interval 26.2 to 32.6	—	—
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 Serotype 8	52.1 Percentage of participants Interval 48.5 to 55.6	53.8 Percentage of participants Interval 50.2 to 57.3	—	—
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 Serotype 9V	41.4 Percentage of participants Interval 38.0 to 44.9	43.6 Percentage of participants Interval 40.1 to 47.1	—	—
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 Serotype 10A	56.5 Percentage of participants Interval 52.9 to 60.1	62.0 Percentage of participants Interval 58.4 to 65.5	—	—
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 Serotype 11A	43.5 Percentage of participants Interval 39.8 to 47.2	50.6 Percentage of participants Interval 46.8 to 54.4	—	—
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 Serotype 14	24.8 Percentage of participants Interval 21.8 to 27.9	30.3 Percentage of participants Interval 27.2 to 33.6	—	—
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 Serotype 15B	56.7 Percentage of participants Interval 53.1 to 60.3	60.8 Percentage of participants Interval 57.2 to 64.3	—	—
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 Serotype 18C	39.3 Percentage of participants Interval 35.9 to 42.7	42.7 Percentage of participants Interval 39.2 to 46.1	—	—
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 Serotype 19A	36.0 Percentage of participants Interval 32.8 to 39.4	40.2 Percentage of participants Interval 36.8 to 43.7	—	—
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 Serotype 19F	33.9 Percentage of participants Interval 30.7 to 37.2	38.6 Percentage of participants Interval 35.3 to 42.1	—	—
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 Serotype 22F	68.7 Percentage of participants Interval 65.1 to 72.1	72.0 Percentage of participants Interval 68.5 to 75.3	—	—
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 Serotype 23F	49.8 Percentage of participants Interval 46.3 to 53.2	55.1 Percentage of participants Interval 51.6 to 58.5	—	—
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 Serotype 33F	39.1 Percentage of participants Interval 35.6 to 42.7	47.7 Percentage of participants Interval 44.1 to 51.4	—	—

SECONDARY outcome

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=854 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=834 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 1	3.0 Fold rise Interval 2.8 to 3.3	4.0 Fold rise Interval 3.6 to 4.5	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 3	2.5 Fold rise Interval 2.3 to 2.7	3.1 Fold rise Interval 2.8 to 3.3	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 4	6.2 Fold rise Interval 5.4 to 7.1	7.4 Fold rise Interval 6.4 to 8.5	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 5	2.4 Fold rise Interval 2.2 to 2.6	2.7 Fold rise Interval 2.5 to 3.0	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 6A	8.8 Fold rise Interval 7.7 to 10.1	11.9 Fold rise Interval 10.4 to 13.7	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 6B	6.5 Fold rise Interval 5.8 to 7.3	8.4 Fold rise Interval 7.4 to 9.5	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 7F	2.6 Fold rise Interval 2.4 to 2.8	2.8 Fold rise Interval 2.5 to 3.1	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 8	5.8 Fold rise Interval 5.1 to 6.6	7.3 Fold rise Interval 6.3 to 8.3	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 9V	4.0 Fold rise Interval 3.6 to 4.5	4.3 Fold rise Interval 3.8 to 4.8	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 10A	8.0 Fold rise Interval 7.0 to 9.2	10.1 Fold rise Interval 8.8 to 11.6	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 11A	4.4 Fold rise Interval 3.9 to 5.1	6.2 Fold rise Interval 5.3 to 7.1	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 12F	11.4 Fold rise Interval 9.7 to 13.3	14.4 Fold rise Interval 12.2 to 17.0	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 18C	4.6 Fold rise Interval 4.0 to 5.2	5.2 Fold rise Interval 4.5 to 5.9	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 14	2.5 Fold rise Interval 2.3 to 2.8	3.0 Fold rise Interval 2.7 to 3.4	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 19A	3.7 Fold rise Interval 3.3 to 4.1	4.2 Fold rise Interval 3.8 to 4.7	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 15B	11.7 Fold rise Interval 9.9 to 14.0	16.4 Fold rise Interval 13.6 to 19.8	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 19F	3.0 Fold rise Interval 2.7 to 3.3	3.3 Fold rise Interval 3.0 to 3.7	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 22F	23.6 Fold rise Interval 19.4 to 28.6	32.3 Fold rise Interval 26.5 to 39.4	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 23F	6.4 Fold rise Interval 5.6 to 7.2	8.5 Fold rise Interval 7.4 to 9.7	—	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Serotype 33F	3.3 Fold rise Interval 3.0 to 3.7	4.8 Fold rise Interval 4.2 to 5.4	—	—

SECONDARY outcome

Timeframe: Before Vaccination 1 to 1 month after Vaccination 1 with SIIV

Population: 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.

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.

Outcome measures

Outcome measures
Measure	(SIIV+20vPnC)/Saline: Coadministration n=861 Participants 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.	(SIIV+Saline)/20vPnC: Separate Administration n=865 Participants 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.	Saline Only 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.	Separate 20vPnC 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.
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV A/H1N1	1.8 Fold rise Interval 1.7 to 2.0	1.8 Fold rise Interval 1.6 to 2.0	—	—
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV A/H3N2	2.0 Fold rise Interval 1.8 to 2.2	2.0 Fold rise Interval 1.8 to 2.2	—	—
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV B/Victoria	1.7 Fold rise Interval 1.6 to 1.8	1.7 Fold rise Interval 1.6 to 1.9	—	—
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV B/Phuket	1.4 Fold rise Interval 1.3 to 1.5	1.4 Fold rise Interval 1.3 to 1.5	—	—

Adverse Events

(SIIV+20vPnC)/Saline: Coadministration

Serious events: 33 serious events

Other events: 629 other events

Deaths: 2 deaths

(SIIV+Saline)/20vPnC: Separate Administration

Serious events: 33 serious events

Other events: 644 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	(SIIV+20vPnC)/Saline: Coadministration n=895 participants at risk 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.	(SIIV+Saline)/20vPnC: Separate Administration n=896 participants at risk 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.
General disorders Fatigue (FATIGUE)	37.1% 332/895 • 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 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.	33.4% 299/896 • 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 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.
General disorders Injection site erythema (REDNESS)	6.4% 57/895 • 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 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.	7.5% 67/896 • 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 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.
General disorders Injection site pain (PAIN)	49.2% 440/895 • 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 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.	51.5% 461/896 • 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 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.
General disorders Injection site swelling (SWELLING)	8.2% 73/895 • 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 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.	8.5% 76/896 • 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 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.
General disorders Pyrexia (FEVER)	1.9% 17/895 • 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 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.	1.0% 9/896 • 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 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.
Infections and infestations COVID-19	1.3% 12/895 • 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 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.	2.0% 18/896 • 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 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.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	16.5% 148/895 • 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 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.	17.3% 155/896 • 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 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.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	23.1% 207/895 • 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 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.	22.2% 199/896 • 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 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.
Nervous system disorders Headache (HEADACHE)	26.9% 241/895 • 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 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.	25.8% 231/896 • 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 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.
Injury, poisoning and procedural complications Fall	1.2% 11/895 • 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 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.	1.3% 12/896 • 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 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.
Investigations SARS-CoV-2 test positive	1.6% 14/895 • 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 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.	2.2% 20/896 • 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 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.

Additional Information

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Results disclosure agreements

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