Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health (NCT NCT03339713)
NCT ID: NCT03339713
Last Updated: 2025-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
28 days after vaccination (Day 29)
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
86
|
88
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
Baseline characteristics by cohort
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=90 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
66 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccination (Day 29)Population: 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.
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=85 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=89 Participants
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.
|
|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
A/Michigan strain
|
215 Titers
Interval 160.0 to 289.0
|
168 Titers
Interval 125.0 to 226.0
|
|
Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
A/Hong Kong strain
|
98 Titers
Interval 73.0 to 131.0
|
80 Titers
Interval 61.0 to 103.0
|
|
Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
B/Brisbane strain
|
39 Titers
Interval 31.0 to 49.0
|
40 Titers
Interval 31.0 to 51.0
|
|
Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains
B/Phuket strain
|
35 Titers
Interval 28.0 to 43.0
|
35 Titers
Interval 27.0 to 46.0
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 1 on Day 1 (Day 8)Population: 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).
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=90 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)
Post-dose 1: Solicited local AEs
|
80.0 Percentage of participants
|
45.6 Percentage of participants
|
|
Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs)
Post-dose 1: Solicited systemic AEs
|
63.3 Percentage of participants
|
27.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2 on Day 29 (Day 36)Population: 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.
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs
Post-dose 2: Solicited local AEs
|
6.8 Percentage of participants
|
76.7 Percentage of participants
|
|
Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs
Post-dose 2: Solicited systemic AEs
|
18.2 Percentage of participants
|
70.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 1 on Day 1 (Day 29)Population: 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).
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=90 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 1: Percentage of Participants With Unsolicited AEs
|
36.7 Percentage of participants
|
33.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 2 on Day 29 (Day 57)Population: 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.
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 2: Percentage of Participants With Unsolicited AEs
|
18.2 Percentage of participants
|
18.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 6 months post-dose 1 (Day 183)Population: 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).
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=90 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs)
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 6 months post-dose 2 (Day 211)Population: 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.
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.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Post-dose 2: Percentage of Participants With SAEs
|
1 Percentage of participants
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (post Ad26.RSV.preF)Population: 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.
RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
Baseline
|
497 Titers
Interval 429.0 to 576.0
|
539 Titers
Interval 458.0 to 636.0
|
|
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
Day 29
|
1404 Titers
Interval 1208.0 to 1633.0
|
1690 Titers
Interval 1433.0 to 1993.0
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (post Ad26.RSV.preF)Population: 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.
GMT (ELISA units per litre \[EU/L\]) of RSV F protein in pre-fusion form by ELISA was reported.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
Day 29
|
781 EU/L
Interval 694.0 to 879.0
|
814 EU/L
Interval 711.0 to 932.0
|
|
RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
Baseline
|
333 EU/L
Interval 289.0 to 384.0
|
315 EU/L
Interval 267.0 to 371.0
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (post Ad26.RSV.preF)Population: 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.
GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported.
Outcome measures
| Measure |
Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo
n=88 Participants
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.
|
Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp)
n=90 Participants
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.
|
|---|---|---|
|
RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion
Baseline
|
256 EU/L
Interval 223.0 to 295.0
|
236 EU/L
Interval 203.0 to 274.0
|
|
RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion
Day 29
|
506 EU/L
Interval 444.0 to 577.0
|
484 EU/L
Interval 426.0 to 549.0
|
Adverse Events
Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 1 Post-Dose 2: Placebo (Day 29)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)
n=90 participants at risk
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.
|
Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)
n=90 participants at risk
Participants received a single dose of intramuscular injection of matching placebo on Day 1 along with Fluarix administered at the same time.
|
Group 1 Post-Dose 2: Placebo (Day 29)
n=88 participants at risk
Participants received a single dose of intramuscular injection of matching placebo on Day 29.
|
Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)
n=90 participants at risk
Participants received a single dose of intramuscular injection of Ad26.RSV.preF on Day 29.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
1.1%
1/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Renal and urinary disorders
Renal Injury
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
1.1%
1/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
1.1%
1/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Nervous system disorders
Syncope
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
1.1%
1/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
Other adverse events
| Measure |
Group 1 Post-Dose 1: Ad26.RSV.preF (1*10^11 vp) + Fluarix Quadrivalent (Day 1)
n=90 participants at risk
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.
|
Group 2 Post-Dose 1: Placebo + Fluarix Quadrivalent (Day 1)
n=90 participants at risk
Participants received a single dose of intramuscular injection of matching placebo on Day 1 along with Fluarix administered at the same time.
|
Group 1 Post-Dose 2: Placebo (Day 29)
n=88 participants at risk
Participants received a single dose of intramuscular injection of matching placebo on Day 29.
|
Group 2 Post-Dose 2: Ad26.RSV.preF (Day 29)
n=90 participants at risk
Participants received a single dose of intramuscular injection of Ad26.RSV.preF on Day 29.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.3%
2/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
General disorders
Injection Site Pruritus
|
1.1%
1/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.2%
2/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.3%
2/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Infections and infestations
Respiratory Tract Infection
|
11.1%
10/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
12.2%
11/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
8.0%
7/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
5.6%
5/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Infections and infestations
Urinary Tract Infection
|
2.2%
2/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.2%
2/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.3%
2/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Investigations
Blood Pressure Increased
|
5.6%
5/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
4.4%
4/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
3.4%
3/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
5.6%
5/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Nervous system disorders
Headache
|
2.2%
2/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
1.1%
1/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.3%
2/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
|
Vascular disorders
Hypertension
|
1.1%
1/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
0.00%
0/88 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
2.2%
2/90 • SAEs were collected up to end of study (Day 211) and non-serious AEs were collected up to 28 days Post-dose 1 (Day 29) and Post-dose 2 (Day 57).
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 (Fluarix Quadrivalent, Ad26.RSV.preF or placebo). Reported AEs were presented as pre-specified in the study protocol.
|
Additional Information
Clinical Franchise Leader
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER