A Study to Evaluate the Safety and Immunogenicity of Seas... | NCT03339713

NCT03339713

ID	Type	Description	Link
VAC18193RSV2003	Other Identifier	Janssen Vaccines & Prevention B.V.

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1	Experimental	Participants will receive intramuscular injection of 1*10^11 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on 1 arm administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on the other arm at Day 1, and intramuscular injection of placebo on Day 29.	Biological: Ad26.RSV.preF Biological: Fluarix Biological: Placebo
Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2	Experimental	Participants will receive intramuscular injection of placebo administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on Day 1, and 1*10^11 vp of Ad26.RSV.preF on Day 29.	Biological: Ad26.RSV.preF Biological: Fluarix Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ad26.RSV.preF	Biological	Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.	Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains	Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants.	28 days after vaccination (Day 29)
Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)	Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.	Up to 7 days post-dose 1 on Day 1 (Day 8)
Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs	Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.	Up to 7 days post-dose 2 on Day 29 (Day 36)
Post-dose 1: Percentage of Participants With Unsolicited AEs	Percentage of participants with unsolicited AEs were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.

Secondary Outcomes

Measure	Description	Time Frame
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers	RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay.	Baseline and Day 29 (post Ad26.RSV.preF)
RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
Before randomization, a woman must be:
1. Postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and
2. Not intending to conceive by any methods
In the investigator's clinical judgment, participant must be either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1
From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine
Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

Name	Affiliation	Role
Janssen Vaccines & Prevention B.V. Clinical Trial	Janssen Vaccines & Prevention B.V.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Carolina Research Center		Mt. Pleasant	South Carolina	29464	United States

PubMed Identifier	Type	Citation	Retractions
32851411	Derived	Sadoff J, De Paepe E, Haazen W, Omoruyi E, Bastian AR, Comeaux C, Heijnen E, Strout C, Schuitemaker H, Callendret B. Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults. J Infect Dis. 2021 Feb 24;223(4):699-708. doi: 10.1093/infdis/jiaa409.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 6, 2017	Jul 22, 2021

Arm/Group Information

ID	Title	Description
BG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
BG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00090 BG00190 BG002180

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00064(60 to 82) BG00166(60 to 81) BG00265(60 to 82)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00057 BG00156 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

UNITED STATES

Title	Measurements
	BG00090 BG00190 BG002

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

Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains

Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants.

The Per-protocol influenza immunogenicity (PPII) set included participants who were randomized and received the first vaccination for whom immunogenicity data are available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Posted

Geometric Mean

95% Confidence Interval

Titers

28 days after vaccination (Day 29)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Units	Counts
Participants	OG00085 OG00189

Title

Denominators

Categories

A/Michigan strain

Title	Measurements
	OG000215(160 to 289) OG001168(125 to 226)

A/Hong Kong strain

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.	t-test, 1 sided		<.001		Geometric Mean Ratio	0.8			2-Sided	90	0.55	1.11					Non-Inferiority	Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).

Primary

Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)

Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.

Posted

Number

Percentage of participants

Up to 7 days post-dose 1 on Day 1 (Day 8)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Primary

Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs

The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations and vaccine type (seasonal influenza, Ad26.RSV.preF or placebo). Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Up to 7 days post-dose 2 on Day 29 (Day 36)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)

Primary

Post-dose 1: Percentage of Participants With Unsolicited AEs

Percentage of participants with unsolicited AEs were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.

Posted

Number

Percentage of participants

Up to 28 days post-dose 1 on Day 1 (Day 29)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Primary

Post-dose 2: Percentage of Participants With Unsolicited AEs

Percentage of participants with unsolicited AEs 2 were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.

Posted

Number

Percentage of participants

Up to 28 days post-dose 2 on Day 29 (Day 57)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Primary

Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs)

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Posted

Number

Percentage of participants

Up to 6 months post-dose 1 (Day 183)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Primary

Post-dose 2: Percentage of Participants With SAEs

Posted

Number

Percentage of participants

Up to 6 months post-dose 2 (Day 211)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Secondary

Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers

RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay.

The Per-protocol RSV Immunogenicity (PPRI) set included all randomized and fully vaccinated participants (all three vaccinations, ie, Fluarix Quadrivalent, Ad26.RSV.preF and placebo) for whom immunogenicity data are available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline and Day 29 (post Ad26.RSV.preF)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Secondary

RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion

GMT (ELISA units per litre [EU/L]) of RSV F protein in pre-fusion form by ELISA was reported.

The PPRI set included all randomized and fully vaccinated participants (all three vaccinations, ie, Fluarix Quadrivalent, Ad26.RSV.preF and placebo) for whom immunogenicity data are available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified timepoints.

Posted

Geometric Mean

95% Confidence Interval

EU/L

Baseline and Day 29 (post Ad26.RSV.preF)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Secondary

RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion

GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported.

Posted

Geometric Mean

95% Confidence Interval

EU/L

Baseline and Day 29 (post Ad26.RSV.preF)

ID	Title	Description
OG000	Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo	Participants received a single dose of intramuscular injection of 1*10^11 viral particles (vp) of Adenovirus serotype 26 Respiratory Syncytial Virus pre-fusion conformation stabilized F protein (Ad26.RSV.preF) on Day 1 along with Fluarix administered at the same time, followed by placebo as second vaccine on Day 29.
OG001	Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)	Participants received a single dose of intramuscular injection of placebo on Day 1 along with Fluarix administered at the same time, followed by 1*10^11 vp Ad26.RSV.preF as second vaccine on Day 29.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)	Participants received a single dose of intramuscular injection of 1*10^11 vp (viral particles) of Ad26.RSV.preF on Day 1 along with Fluarix administered at the same time.	90	0	90	22	90
EG001	Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)	Participants received a single dose of intramuscular injection of matching placebo on Day 1 along with Fluarix administered at the same time.	90	0	90	18	90
EG002	Group 1 Post-Dose 2: Placebo (Day 29)	Participants received a single dose of intramuscular injection of matching placebo on Day 29.	88	1	88	13	88
EG003	Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)	Participants received a single dose of intramuscular injection of Ad26.RSV.preF on Day 29.	90	1	90	14	90

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected90 at risk EG0010 affected90 at risk EG0022 affected88 at risk EG0030 affected90 at risk
Injection Site Pruritus	General disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected90 at risk EG0010 affected90 at risk EG0020 affected88 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0022 affected88 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG00010 affected90 at risk EG00111 affected90 at risk EG0027 affected88 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected90 at risk EG0012 affected90 at risk EG0020 affected88 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0022 affected88 at risk EG003
Blood Pressure Increased	Investigations	MedDRA Version 21.0	Non-systematic Assessment	EG0005 affected90 at risk EG0014 affected90 at risk EG0023 affected88 at risk EG003
Headache	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0002 affected90 at risk EG0011 affected90 at risk EG0022 affected88 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0001 affected90 at risk EG0010 affected90 at risk EG0020 affected88 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0021 affected88 at risk EG0030 affected90 at risk
Renal Injury	Renal and urinary disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0021 affected88 at risk EG003
Hypertensive Emergency	Vascular disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0021 affected88 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 21.0	Non-systematic Assessment	EG0000 affected90 at risk EG0010 affected90 at risk EG0020 affected88 at risk EG003