Trial Outcomes & Findings for Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age (NCT NCT05301322)

Last Updated: 2023-10-27

Results Overview

Local reactions were collected at the RSVpreF or placebo injection site after Vaccination 1 and Vaccination 2 and were recorded by participants using electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units where, 1 measuring device unit =0.5 centimeter (cm) and 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 reporting local reactions at injection site in Coadministration Group, and Sequential-Administration Group and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented in this outcome measure (OM). Safety population=all enrolled participants who received study intervention (RSVpreF, placebo).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1471 participants

Primary outcome timeframe

Within 7 days after Vaccination 1 or Vaccination 2

Results posted on

2023-10-27

Participant Flow

A total of 1471 participants signed the informed consent and were enrolled in the study, of which 68 were screen failures and 1403 participants were randomized to a vaccine group.

Participant milestones

Participant milestones
Measure	(RSVpreF + SIIV)/Placebo: Coadministration Group Participants were randomized to receive a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and placebo intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group Participants were randomized to receive a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.
Overall Study STARTED	705	698
Overall Study Not Vaccinated	3	1
Overall Study Vaccination 1	702	697
Overall Study Vaccination 2	688	693
Overall Study COMPLETED	686	692
Overall Study NOT COMPLETED	19	6

Reasons for withdrawal

Reasons for withdrawal
Measure	(RSVpreF + SIIV)/Placebo: Coadministration Group Participants were randomized to receive a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and placebo intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group Participants were randomized to receive a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.
Overall Study Adverse Event	7	3
Overall Study Death	0	1
Overall Study Lost to Follow-up	2	1
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	3	0
Overall Study Other	4	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(RSVpreF + SIIV)/Placebo: Coadministration Group n=703 Participants Participants were randomized to receive a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and placebo intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group n=696 Participants Participants were randomized to receive a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1) on Day 1; and 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2) after 1 month. Participants were followed up for 1 month after Vaccination 2.	Total n=1399 Participants Total of all reporting groups
Age, Continuous	70.7 Years STANDARD_DEVIATION 4.7 • n=5 Participants	70.7 Years STANDARD_DEVIATION 4.7 • n=7 Participants	70.7 Years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	398 Participants n=5 Participants	372 Participants n=7 Participants	770 Participants n=5 Participants
Sex: Female, Male Male	305 Participants n=5 Participants	324 Participants n=7 Participants	629 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	652 Participants n=5 Participants	647 Participants n=7 Participants	1299 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	669 Participants n=5 Participants	665 Participants n=7 Participants	1334 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days after Vaccination 1 or Vaccination 2

Population: Safety population was analyzed. 'Overall Number of Participants (Par) Analyzed' (N)= par with at least 1 e-diary (within 7 days through Vaccination \[vax\]) transmitted. 1 par randomized in Sequential-Administration Group (SAG) incorrectly received RSVpreF + SIIV at Vax 1; hence, par was included in (RSVpreF + SIIV)/Placebo. 1 par randomized in SAG incorrectly received placebo at Vax 2; hence, par was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=701 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=681 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group n=693 Participants On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group n=686 Participants One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Pain at injection site: Mild	10.1 Percentage of participants Interval 8.0 to 12.6	6.5 Percentage of participants Interval 4.7 to 8.6	7.6 Percentage of participants Interval 5.8 to 9.9	11.5 Percentage of participants Interval 9.2 to 14.1
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Pain at injection site: Moderate	1.3 Percentage of participants Interval 0.6 to 2.4	0.9 Percentage of participants Interval 0.3 to 1.9	0.7 Percentage of participants Interval 0.2 to 1.7	0.9 Percentage of participants Interval 0.3 to 1.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Pain at injection site: Severe	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Redness: Mild	2.1 Percentage of participants Interval 1.2 to 3.5	0.3 Percentage of participants Interval 0.0 to 1.1	0.6 Percentage of participants Interval 0.2 to 1.5	0.7 Percentage of participants Interval 0.2 to 1.7
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Redness: Moderate	0.9 Percentage of participants Interval 0.3 to 1.9	0.1 Percentage of participants Interval 0.0 to 0.8	0.1 Percentage of participants Interval 0.0 to 0.8	0.9 Percentage of participants Interval 0.3 to 1.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Swelling: Severe	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0.1 Percentage of participants Interval 0.0 to 0.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Redness: Severe	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Swelling: Mild	1.6 Percentage of participants Interval 0.8 to 2.8	0.3 Percentage of participants Interval 0.0 to 1.1	0.1 Percentage of participants Interval 0.0 to 0.8	1.2 Percentage of participants Interval 0.5 to 2.3
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo Swelling: Moderate	1.3 Percentage of participants Interval 0.6 to 2.4	0 Percentage of participants Interval 0.0 to 0.5	0 Percentage of participants Interval 0.0 to 0.5	0.6 Percentage of participants Interval 0.2 to 1.5

PRIMARY outcome

Timeframe: Within 7 days after Vaccination 1 or Vaccination 2

Population: Safety population= all enrolled participants who received study intervention (RSVpreF, placebo). N= participant with at least 1 e-diary (within 7 days through vax) transmitted. 1 participant randomized in SAG incorrectly received RSVpreF + SIIV at Vax 1; hence, participant was included in (RSVpreF + SIIV)/Placebo. 1 participant randomized in SAG incorrectly received placebo at Vax 2; hence,participant was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

Systemic events included fever, fatigue, headache, nausea, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using an e-diary. Fever was defined as an oral temperature \>=38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), \>38.9 to 40.0 deg C (severe) and \>40.0 deg C (grade 4). Fatigue, headache, nausea, 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). Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. 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	RSVpreF + SIIV: Coadministration Group n=701 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=681 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group n=693 Participants On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group n=686 Participants One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fever: Severe	0.4 Percentage of Participants Interval 0.1 to 1.2	0 Percentage of Participants Interval 0.0 to 0.5	0.3 Percentage of Participants Interval 0.0 to 1.0	0 Percentage of Participants Interval 0.0 to 0.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fatigue: Mild	15.4 Percentage of Participants Interval 12.8 to 18.3	10.1 Percentage of Participants Interval 8.0 to 12.6	15.6 Percentage of Participants Interval 13.0 to 18.5	11.5 Percentage of Participants Interval 9.2 to 14.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Vomiting: Mild	0.4 Percentage of Participants Interval 0.1 to 1.2	0.3 Percentage of Participants Interval 0.0 to 1.1	0.4 Percentage of Participants Interval 0.1 to 1.3	1.0 Percentage of Participants Interval 0.4 to 2.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Nausea: Mild	4.4 Percentage of Participants Interval 3.0 to 6.2	3.7 Percentage of Participants Interval 2.4 to 5.4	4.6 Percentage of Participants Interval 3.2 to 6.5	4.2 Percentage of Participants Interval 2.8 to 6.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fever: Mild	1.1 Percentage of Participants Interval 0.5 to 2.2	0.7 Percentage of Participants Interval 0.2 to 1.7	0.9 Percentage of Participants Interval 0.3 to 1.9	1.0 Percentage of Participants Interval 0.4 to 2.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fever: Moderate	0.3 Percentage of Participants Interval 0.0 to 1.0	0.1 Percentage of Participants Interval 0.0 to 0.8	0.3 Percentage of Participants Interval 0.0 to 1.0	0.1 Percentage of Participants Interval 0.0 to 0.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fever: Grade 4 (>40.0 deg C)	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fatigue: Moderate	13.7 Percentage of Participants Interval 11.2 to 16.5	7.5 Percentage of Participants Interval 5.6 to 9.7	11.3 Percentage of Participants Interval 9.0 to 13.8	7.0 Percentage of Participants Interval 5.2 to 9.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Fatigue: Severe	0.9 Percentage of Participants Interval 0.3 to 1.9	0 Percentage of Participants Interval 0.0 to 0.5	0.3 Percentage of Participants Interval 0.0 to 1.0	0.6 Percentage of Participants Interval 0.2 to 1.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Headache: Mild	13.7 Percentage of Participants Interval 11.2 to 16.5	10.4 Percentage of Participants Interval 8.2 to 13.0	14.3 Percentage of Participants Interval 11.8 to 17.1	10.6 Percentage of Participants Interval 8.4 to 13.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Headache: Moderate	5.8 Percentage of Participants Interval 4.2 to 7.9	4.6 Percentage of Participants Interval 3.1 to 6.4	6.1 Percentage of Participants Interval 4.4 to 8.1	5.4 Percentage of Participants Interval 3.8 to 7.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Headache: Severe	0.1 Percentage of Participants Interval 0.0 to 0.8	0.1 Percentage of Participants Interval 0.0 to 0.8	0.6 Percentage of Participants Interval 0.2 to 1.5	0.1 Percentage of Participants Interval 0.0 to 0.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Vomiting: Moderate	0.6 Percentage of Participants Interval 0.2 to 1.5	0.1 Percentage of Participants Interval 0.0 to 0.8	0.1 Percentage of Participants Interval 0.0 to 0.8	0.1 Percentage of Participants Interval 0.0 to 0.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Vomiting: Severe	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Nausea: Moderate	2.7 Percentage of Participants Interval 1.6 to 4.2	1.0 Percentage of Participants Interval 0.4 to 2.1	1.2 Percentage of Participants Interval 0.5 to 2.3	1.2 Percentage of Participants Interval 0.5 to 2.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Nausea: Severe	0.4 Percentage of Participants Interval 0.1 to 1.2	0 Percentage of Participants Interval 0.0 to 0.5	0.3 Percentage of Participants Interval 0.0 to 1.0	0 Percentage of Participants Interval 0.0 to 0.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Diarrhea: Mild	6.1 Percentage of Participants Interval 4.5 to 8.2	3.2 Percentage of Participants Interval 2.0 to 4.9	4.9 Percentage of Participants Interval 3.4 to 6.8	4.5 Percentage of Participants Interval 3.1 to 6.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Diarrhea: Moderate	2.0 Percentage of Participants Interval 1.1 to 3.3	1.5 Percentage of Participants Interval 0.7 to 2.7	1.2 Percentage of Participants Interval 0.5 to 2.3	1.5 Percentage of Participants Interval 0.7 to 2.7
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Diarrhea: Severe	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0.1 Percentage of Participants Interval 0.0 to 0.8	0.3 Percentage of Participants Interval 0.0 to 1.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Muscle pain: Mild	10.1 Percentage of Participants Interval 8.0 to 12.6	6.9 Percentage of Participants Interval 5.1 to 9.1	7.5 Percentage of Participants Interval 5.7 to 9.7	5.8 Percentage of Participants Interval 4.2 to 7.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Muscle pain: Moderate	5.6 Percentage of Participants Interval 4.0 to 7.5	2.1 Percentage of Participants Interval 1.1 to 3.4	4.8 Percentage of Participants Interval 3.3 to 6.6	3.5 Percentage of Participants Interval 2.3 to 5.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Muscle pain: Severe	0.1 Percentage of Participants Interval 0.0 to 0.8	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0.1 Percentage of Participants Interval 0.0 to 0.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Joint pain: Mild	6.8 Percentage of Participants Interval 5.1 to 9.0	5.1 Percentage of Participants Interval 3.6 to 7.1	5.8 Percentage of Participants Interval 4.2 to 7.8	4.2 Percentage of Participants Interval 2.8 to 6.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Joint pain: Moderate	4.3 Percentage of Participants Interval 2.9 to 6.1	2.2 Percentage of Participants Interval 1.2 to 3.6	3.5 Percentage of Participants Interval 2.2 to 5.1	2.8 Percentage of Participants Interval 1.7 to 4.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo Joint pain: Severe	0.4 Percentage of Participants Interval 0.1 to 1.2	0 Percentage of Participants Interval 0.0 to 0.5	0 Percentage of Participants Interval 0.0 to 0.5	0.1 Percentage of Participants Interval 0.0 to 0.8

PRIMARY outcome

Timeframe: Within 1 month after Vaccination 1

Population: Safety population = all enrolled participants who received study intervention (RSVpreF, placebo). N = participants evaluable for this outcome measure. 1 participant randomized in SAG incorrectly received RSVpreF + SIIV at Vax 1; hence, participant was included in (RSVpreF + SIIV)/Placebo. 1 participant randomized in SAG incorrectly received placebo at Vax 2; hence, participant was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

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. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=703 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=695 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1	21.9 Percentage of participants Interval 18.9 to 25.1	19.3 Percentage of participants Interval 16.4 to 22.4	—	—

PRIMARY outcome

Timeframe: Within 1 month after Vaccination 2

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. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=689 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=691 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2	17.0 Percentage of participants Interval 14.3 to 20.0	16.6 Percentage of participants Interval 13.9 to 19.6	—	—

PRIMARY outcome

Timeframe: Within 1 month after Vaccination 1

An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was 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. Percentage of participants reporting SAEs within 1 month after Vaccination 1 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=703 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=695 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1	1.1 Percentage of participants Interval 0.5 to 2.2	0.9 Percentage of participants Interval 0.3 to 1.9	—	—

PRIMARY outcome

Timeframe: Within 1 month after Vaccination 2

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=689 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=691 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2	0.3 Percentage of participants Interval 0.0 to 1.0	0.7 Percentage of participants Interval 0.2 to 1.7	—	—

PRIMARY outcome

Timeframe: 1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group

Population: Evaluable RSV immunogenicity population: eligible par who received study interventions (RSVpreF, placebo, or SIIV) as randomized at both Visit (V) 1 \& V 2; had 1-month RSVpreF postvaccination (PV) blood collection 25-49 days after RSVpreF Vax; no major protocol violation from randomization through 1-month RSVpreF PV blood draw; had at least 1 valid \& determinate assay result 1 month after RSVpreF Vax. N= par evaluable for this OM \& 'Number Analyzed'(n) = par evaluable for specified rows.

Geometric mean titer (GMT) of RSV A and RSV B neutralizing titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CI were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMTs in the Coadministration Group to the Sequential-Administration Group.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=681 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=671 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) at 1 Month After Vaccination With RSVpreF for RSV Subfamily A and B in RSVpreF + SIIV Compared to RSVpreF Alone RSV A	19709.9 Titer Interval 18445.0 to 21061.7	22817.1 Titer Interval 21284.8 to 24459.7	—	—
Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) at 1 Month After Vaccination With RSVpreF for RSV Subfamily A and B in RSVpreF + SIIV Compared to RSVpreF Alone RSV B	18384.5 Titer Interval 17093.1 to 19773.5	21621.4 Titer Interval 20071.6 to 23290.8	—	—

PRIMARY outcome

Timeframe: 1 month after Vaccination 1

Population: Evaluable SIIV immunogenicity population: eligible participants who received study interventions (RSVpreF, placebo, or SIIV) as randomized with SIIV at Visit 1; had 1-month postvaccination blood collection 25-49 days after SIIV vaccination; no major protocol violation from randomization through 1-month postvaccination blood draw; had at least 1 valid and determinate assay result 1 month after SIIV vaccination. N= participants evaluable for this OM \& n= participants evaluable for specified rows.

GMTs of strain-specific HAI titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMR was reported in the statistical analysis section and was calculated as ratio of GMT in the Coadministration Group to the Sequential-Administration Group.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=680 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=687 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group HAI: H1N1 A/Victoria	139.6 Titer Interval 128.8 to 151.2	162.2 Titer Interval 149.9 to 175.6	—	—
GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group HAI: H3N2 A/Darwin	104.7 Titer Interval 96.3 to 113.8	136.4 Titer Interval 125.0 to 148.8	—	—
GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group HAI: B/Austria	113.3 Titer Interval 103.2 to 124.3	126.3 Titer Interval 115.6 to 138.0	—	—
GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group HAI: B/Phuket	106.7 Titer Interval 98.7 to 115.4	123.2 Titer Interval 114.6 to 132.4	—	—

SECONDARY outcome

Timeframe: Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after RSVpreF vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after RSVpreF vaccination

Population: Evaluable RSV immunogenicity population: eligible participants who received study interventions (RSVpreF, placebo, or SIIV) as randomized at both V 1 \& V 2; had 1-month RSVpreF PV blood collection 25-49 days after RSVpreF Vax; no major protocol violation from randomization through 1-month RSVpreF PV blood draw; had at least 1 valid and determinate assay result 1 month after RSVpreF Vax. 'N' = participants evaluable for this outcome measure and 'n' = participants evaluable for specified rows.

GMT of neutralizing titers of RSV A and RSV B before vaccination, at 1 month and 2 months after vaccination was reported in this outcome measure. Assay results below the LLOQ were set to 0.5\*LLOQ. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). For Sequential-Administration Group, the time point for 2 months after vaccination was not reported since the participants received RSVpreF at Vaccination 2 and were followed up for 1 month after Vaccination 2.

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=681 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=671 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV A: 2 Months after RSVpreF vaccination	15357.5 Titer Interval 14395.8 to 16383.5	—	—	—
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV A: Before RSVpreF vaccination	1951.2 Titer Interval 1829.4 to 2081.2	1999.1 Titer Interval 1862.4 to 2145.8	—	—
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV A: 1 Month after RSVpreF vaccination	19709.9 Titer Interval 18445.0 to 21061.7	22817.1 Titer Interval 21284.8 to 24459.7	—	—
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV B: Before RSVpreF vaccination	1810.2 Titer Interval 1695.7 to 1932.4	1807.6 Titer Interval 1683.0 to 1941.4	—	—
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV B: 1 Month after RSVpreF vaccination	18384.5 Titer Interval 17093.1 to 19773.5	21621.4 Titer Interval 20071.6 to 23290.8	—	—
Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV B: 2 Months after RSVpreF vaccination	13681.7 Titer Interval 12749.1 to 14682.5	—	—	—

SECONDARY outcome

Timeframe: Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after vaccination

GMFR of neutralizing titers of RSV A and RSV B before vaccination and at 1 month and 2 months after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the Student's t distribution).

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=681 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=670 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV A: 1 month after RSVpreF vaccination	10.0 Fold rise Interval 9.28 to 10.87	11.4 Fold rise Interval 10.46 to 12.36	—	—
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV A: 2 months after RSVpreF vaccination	7.8 Fold rise Interval 7.27 to 8.42	—	—	—
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV B: 1 month after RSVpreF vaccination	10.1 Fold rise Interval 9.38 to 10.97	12.0 Fold rise Interval 11.02 to 12.98	—	—
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF RSV B: 2 months after RSVpreF vaccination	7.6 Fold rise Interval 7.03 to 8.12	—	—	—

SECONDARY outcome

Timeframe: Before SIIV vaccination, and 1 month after vaccination

Population: Evaluable SIIV immunogenicity population: eligible participants who received study interventions (RSVpreF, placebo, or SIIV) as randomized with SIIV at Visit 1; had 1-month PV blood collection 25-49 days after SIIV vaccination; no major protocol violation from randomization through 1-month PV blood draw; had at least 1 valid and determinate assay result 1 month after SIIV vaccination. 'N' = participants evaluable for this outcome measure and 'n' = participants evaluable for specified rows.

HAI GMT before vaccination and 1 month after vaccination with SIIV was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=680 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=687 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV H1N1 A/Victoria: Before SIIV Vaccination	48.8 Titer Interval 44.3 to 53.9	43.3 Titer Interval 39.2 to 47.8	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV H1N1 A/Victoria: 1 Month After SIIV Vaccination	139.6 Titer Interval 128.8 to 151.2	162.2 Titer Interval 149.9 to 175.6	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV H3N2 A/Darwin: Before SIIV Vaccination	21.9 Titer Interval 20.2 to 23.7	21.7 Titer Interval 20.0 to 23.5	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV H3N2 A/Darwin: 1 Month After SIIV Vaccination	104.7 Titer Interval 96.3 to 113.8	136.4 Titer Interval 125.0 to 148.8	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV B/Austria: Before SIIV Vaccination	32.4 Titer Interval 29.3 to 35.8	31.0 Titer Interval 28.2 to 34.1	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV B/Austria: 1 Month After SIIV Vaccination	113.3 Titer Interval 103.2 to 124.3	126.3 Titer Interval 115.6 to 138.0	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV B/Phuket: Before SIIV Vaccination	47.5 Titer Interval 43.3 to 52.0	49.7 Titer Interval 45.4 to 54.3	—	—
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV B/Phuket: 1 Month After SIIV Vaccination	106.7 Titer Interval 98.7 to 115.4	123.2 Titer Interval 114.6 to 132.4	—	—

SECONDARY outcome

Timeframe: Before SIIV vaccination, and 1 month after vaccination

Population: Evaluable SIIV immunogenicity population: eligible participants who received study interventions (RSVpreF, placebo, or SIIV) as randomized with SIIV at Visit 1; had 1-month PV blood collection 25-49 days after SIIV vaccination; no major protocol violation from randomization through 1-month PV blood draw; had at least 1 valid and determinate assay result 1 month after SIIV vaccination. 'N' = participants evaluable for this outcome measure and 'n' = participants evaluable for specified rows.

GMFR of strain-specific HAI titers before vaccination and 1 month after vaccination with SIIV was reported in this outcome measure. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises (later time point over earlier time point) and the corresponding CIs (based on Student's t distribution).

Outcome measures

Outcome measures
Measure	RSVpreF + SIIV: Coadministration Group n=679 Participants On Day 1 (Visit 1), participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid muscle along with 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) intramuscularly into the left deltoid muscle (Vaccination 1).	Placebo: Coadministration Group n=684 Participants One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	Placebo + SIIV: Sequential-Administration Group On Day 1 (Visit 1), participants received a single dose of SIIV intramuscularly into the right deltoid muscle along with placebo intramuscularly into the left deltoid muscle (Vaccination 1).	RSVpreF: Sequential-Administration Group One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV H1N1 A/Victoria	2.6 Fold rise Interval 2.37 to 2.85	3.3 Fold rise Interval 3.0 to 3.65	—	—
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV H3N2 A/Darwin	4.1 Fold rise Interval 3.78 to 4.49	5.4 Fold rise Interval 4.92 to 5.84	—	—
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV B/Austria	3.1 Fold rise Interval 2.8 to 3.32	3.5 Fold rise Interval 3.26 to 3.87	—	—
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV B/Phuket	2.1 Fold rise Interval 1.95 to 2.23	2.3 Fold rise Interval 2.15 to 2.48	—	—

Adverse Events

RSVpreF + SIIV: Coadministration Group

Serious events: 8 serious events

Other events: 418 other events

Deaths: 0 deaths

Placebo: Coadministration Group

Serious events: 2 serious events

Other events: 300 other events

Deaths: 0 deaths

Placebo + SIIV: Sequential-Administration Group

Serious events: 6 serious events

Other events: 370 other events

Deaths: 1 deaths

RSVpreF: Sequential-Administration Group

Serious events: 5 serious events

Other events: 330 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER