Safety and Immunogenicity of RSVpreF Coadministered With... | NCT05301322

Label	Type	Description	Intervention Names
Coadministration Group	Experimental	RSVpreF and SIIV followed by placebo a month later	Biological: RSVpreF Vaccine Other: Placebo Biological: Seasonal Inactivated Influenza Vaccine
Sequential Administration Group	Experimental	Placebo and SIIV followed by RSVpreF a month later	Biological: RSVpreF Vaccine Other: Placebo Biological: Seasonal Inactivated Influenza Vaccine

Name	Type	Description	Arm Group Labels	Other Names
RSVpreF Vaccine	Biological	RSV Vaccine	Coadministration Group Sequential Administration Group

Measure	Description	Time Frame
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo	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).	Within 7 days after Vaccination 1 or Vaccination 2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo	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.	Within 7 days after Vaccination 1 or Vaccination 2
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1

Measure	Description	Time Frame
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	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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Paratus Clinical Research Canberra		Bruce	Australian Capital Territory	2617	Australia
Paratus Clinical Research Western Sydney

PubMed Identifier	Type	Citation	Retractions
37992000	Derived	Athan E, Baber J, Quan K, Scott RJ, Jaques A, Jiang Q, Li W, Cooper D, Cutler MW, Kalinina EV, Anderson AS, Swanson KA, Gruber WC, Gurtman A, Schmoele-Thoma B; Study C3671006 Investigator Group. Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2024 May 15;78(5):1360-1368. doi: 10.1093/cid/ciad707.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	(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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 29, 2022	Oct 4, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo

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).

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 days after Vaccination 1 or Vaccination 2

ID	Title	Description
OG000	RSVpreF + SIIV: Coadministration Group	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).
OG001	Placebo: Coadministration Group	One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).
OG002	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).
OG003	RSVpreF: Sequential-Administration Group	One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).

Units	Counts
Participants	OG000701 OG001681 OG002693 OG003

Title

Denominators

Categories

Pain at injection site: Mild

Title	Measurements
	OG00010.1(8.0 to 12.6) OG0016.5(4.7 to 8.6) OG0027.6(5.8 to 9.9)

Primary

Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo

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.

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.

Posted

Number

95% Confidence Interval

Percentage of Participants

Within 7 days after Vaccination 1 or Vaccination 2

ID	Title	Description
OG000	RSVpreF + SIIV: Coadministration Group

Primary

Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1

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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 1 month after Vaccination 1

ID	Title	Description
OG000	(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.

Primary

Percentage of Participants Reporting Adverse Events (AEs) 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.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 1 month after Vaccination 2

ID	Title	Description
OG000	(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.

Primary

Percentage of Participants Reporting Serious Adverse Events (SAEs) 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.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 1 month after Vaccination 1

ID	Title	Description
OG000	(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.

Primary

Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2

Posted

Number

95% Confidence Interval

Percentage of participants

Within 1 month after Vaccination 2

ID	Title	Description
OG000	(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.

Primary

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

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

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

ID	Title	Description
OG000	(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.

Primary

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

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

1 month after Vaccination 1

ID	Title	Description
OG000	(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.

Secondary

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

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

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

ID	Title	Description
OG000	(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.

Secondary

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

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).

Posted

Geometric Mean

95% Confidence Interval

Fold rise

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

ID	Title	Description
OG000	(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.

Secondary

HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV

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).

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.

Posted

Geometric Mean

95% Confidence Interval

Titer

Before SIIV vaccination, and 1 month after vaccination

ID	Title	Description
OG000	(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.
OG001	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group

Secondary

GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV

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).

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.

Posted

Geometric Mean

95% Confidence Interval

Fold rise

Before SIIV vaccination, and 1 month after vaccination

ID	Title	Description
OG000	(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.
OG001

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG0030 affected691 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Palpitations	Cardiac disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Goitre	Endocrine disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Blepharitis	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dry eye	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Episcleritis	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Glaucoma	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Macular oedema	Eye disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Chest pain	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Chills	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Fatigue	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Fatigue (FATIGUE)	General disorders	MedDRA v25.1	Systematic Assessment	EG000210 affected703 at risk EG001120 affected689 at risk EG002188 affected695 at risk EG003
Feeling hot	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0022 affected695 at risk EG003
Influenza like illness	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0013 affected689 at risk EG0023 affected695 at risk EG003
Injection site bruising	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Injection site pain	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0023 affected695 at risk EG003
Injection site pain (PAIN AT INJECTION SITE)	General disorders	MedDRA v25.1	Systematic Assessment	EG00080 affected703 at risk EG00150 affected689 at risk EG00258 affected695 at risk EG003
Injection site scar	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Injection site swelling	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Localised oedema	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Malaise	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Pain	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Polyp	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Pyrexia (FEVER)	General disorders	MedDRA v25.1	Systematic Assessment	EG00013 affected703 at risk EG0016 affected689 at risk EG00210 affected695 at risk EG003
Swelling (SWELLING)	General disorders	MedDRA v25.1	Systematic Assessment	EG00020 affected703 at risk EG0012 affected689 at risk EG0021 affected695 at risk EG003
Vaccination site pain	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0003 affected703 at risk EG0010 affected689 at risk EG0023 affected695 at risk EG003
Vessel puncture site bruise	General disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0012 affected689 at risk EG0021 affected695 at risk EG003
Diarrhoea (DIARRHEA)	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG00057 affected703 at risk EG00132 affected689 at risk EG00243 affected695 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Nausea (NAUSEA)	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG00053 affected703 at risk EG00132 affected689 at risk EG00242 affected695 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Vomiting (VOMITING)	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0007 affected703 at risk EG0013 affected689 at risk EG0024 affected695 at risk EG003
Allergy to vaccine	Immune system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Asymptomatic COVID-19	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Bronchitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0015 affected689 at risk EG0020 affected695 at risk EG003
COVID-19	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG00036 affected703 at risk EG00130 affected689 at risk EG00227 affected695 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dacryocanaliculitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Diverticulitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0022 affected695 at risk EG003
Ear infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Eye infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0003 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Genital herpes	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Hordeolum	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Influenza	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0022 affected695 at risk EG003
Localised infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0012 affected689 at risk EG0023 affected695 at risk EG003
Nasal herpes	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Oral herpes	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Otitis externa	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Otitis media	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Pharyngitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Post procedural infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0012 affected689 at risk EG0021 affected695 at risk EG003
Sinusitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0012 affected689 at risk EG0020 affected695 at risk EG003
Skin infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Tooth abscess	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Tooth infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0013 affected689 at risk EG0022 affected695 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG00016 affected703 at risk EG00113 affected689 at risk EG00223 affected695 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0022 affected695 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Viral infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0009 affected703 at risk EG0014 affected689 at risk EG0022 affected695 at risk EG003
Wound infection	Infections and infestations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Back injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Chemical burn	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0003 affected703 at risk EG0014 affected689 at risk EG0023 affected695 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0022 affected695 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Skin injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Splinter	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Biopsy breast	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Biopsy skin	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Blood testosterone decreased	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0021 affected695 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0003 affected703 at risk EG0011 affected689 at risk EG0023 affected695 at risk EG003
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG00081 affected703 at risk EG00150 affected689 at risk EG00264 affected695 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0004 affected703 at risk EG0011 affected689 at risk EG0022 affected695 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Greater trochanteric pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG000111 affected703 at risk EG00161 affected689 at risk EG00285 affected695 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0013 affected689 at risk EG0020 affected695 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0022 affected695 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0023 affected695 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Chondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Tumour thrombosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Anosmia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Balance disorder	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Bell's palsy	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dizziness	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0002 affected703 at risk EG0011 affected689 at risk EG0022 affected695 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Headache	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0005 affected703 at risk EG0013 affected689 at risk EG0023 affected695 at risk EG003
Headache (HEADACHE)	Nervous system disorders	MedDRA v25.1	Systematic Assessment	EG000138 affected703 at risk EG001103 affected689 at risk EG002145 affected695 at risk EG003
Lethargy	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Presyncope	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0012 affected689 at risk EG0021 affected695 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Sinus headache	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Syncope	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Ulnar neuritis	Nervous system disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Device breakage	Product Issues	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Depression	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Breast calcifications	Reproductive system and breast disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0006 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Laryngeal granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0012 affected689 at risk EG0021 affected695 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Erythema (REDNESS)	Skin and subcutaneous tissue disorders	MedDRA v25.1	Systematic Assessment	EG00021 affected703 at risk EG0013 affected689 at risk EG0025 affected695 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Scar pain	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Skin hypertrophy	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Umbilical haemorrhage	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0010 affected689 at risk EG0021 affected695 at risk EG003
Flushing	Vascular disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0010 affected689 at risk EG0020 affected695 at risk EG003
Hot flush	Vascular disorders	MedDRA v25.1	Non-systematic Assessment	EG0000 affected703 at risk EG0011 affected689 at risk EG0020 affected695 at risk EG003
Hypertension	Vascular disorders	MedDRA v25.1	Non-systematic Assessment	EG0001 affected703 at risk EG0011 affected689 at risk EG0023 affected695 at risk EG003

ID	Title	Description
BG000	(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.
BG001	(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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RSVpreF + SIIV: Coadministration Group	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).	0	703	8	703	418	703
EG001	Placebo: Coadministration Group	One month after Vaccination 1, participants received placebo intramuscularly into the left deltoid muscle (Vaccination 2).	0	689	2	689	300	689
EG002	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).	1	695	6	695	370	695
EG003	RSVpreF: Sequential-Administration Group	One month after Vaccination 1, participants received 120 mcg RSVpreF intramuscularly into the left deltoid muscle (Vaccination 2).	0	691	5	691	330	691