Healthy
Conditions
Brief summary
The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1\*10\^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.
Interventions
BIOLOGICALAd26.RSV.preF
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp.
BIOLOGICALFluarix
Fluarix will be administered as intramuscular injection.
BIOLOGICALPlacebo
Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-dose 2: Percentage of Participants With SAEs | Up to 6 months post-dose 2 (Day 211) | 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. |
| Post-dose 1: Percentage of Participants With Unsolicited AEs | Up to 28 days post-dose 1 on Day 1 (Day 29) | 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. |
| Post-dose 2: Percentage of Participants With Unsolicited AEs | Up to 28 days post-dose 2 on Day 29 (Day 57) | 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. |
| Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) | Up to 6 months post-dose 1 (Day 183) | 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. |
| Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains | 28 days after vaccination (Day 29) | 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. |
| Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs) | Up to 7 days post-dose 1 on Day 1 (Day 8) | 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. |
| Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs | Up to 7 days post-dose 2 on Day 29 (Day 36) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | Baseline and Day 29 (post Ad26.RSV.preF) | GMT (ELISA units per litre \[EU/L\]) of RSV F protein in pre-fusion form by ELISA was reported. |
| RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | Baseline and Day 29 (post Ad26.RSV.preF) | GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported. |
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Baseline and Day 29 (post Ad26.RSV.preF) | RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| 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. | 90 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Total | Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) |
|---|---|---|---|
| Age, Continuous | 64 years | 65 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 178 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 19 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 79 Participants | 160 Participants | 81 Participants |
| Region of Enrollment UNITED STATES | 90 Participants | 180 Participants | 90 Participants |
| Sex: Female, Male Female | 57 Participants | 113 Participants | 56 Participants |
| Sex: Female, Male Male | 33 Participants | 67 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 | 0 / 88 | 0 / 90 |
| other Total, other adverse events | 22 / 90 | 18 / 90 | 13 / 88 | 14 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 | 1 / 88 | 1 / 90 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | 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 |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains | A/Michigan strain | 168 Titers |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains | B/Brisbane strain | 40 Titers |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains | A/Hong Kong strain | 80 Titers |
Comparison: 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.p-value: <0.00190% CI: [0.55, 1.11]t-test, 1 sided
Comparison: A/Hong Kong 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.p-value: <0.00190% CI: [0.59, 1.12]t-test, 1 sided
Comparison: B/Brisbane 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.p-value: <0.00190% CI: [0.77, 1.34]t-test, 1 sided
Comparison: B/Phuket 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.p-value: <0.00190% CI: [0.76, 1.36]t-test, 1 sided
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs) | Post-dose 1: Solicited local AEs | 45.6 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs) | Post-dose 1: Solicited systemic AEs | 27.8 Percentage of participants |
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) | 0 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) | 0 Percentage of participants |
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Post-dose 1: Percentage of Participants With Unsolicited AEs | 36.7 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 1: Percentage of Participants With Unsolicited AEs | 33.3 Percentage of participants |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | 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 |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs | Post-dose 2: Solicited local AEs | 76.7 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs | Post-dose 2: Solicited systemic AEs | 70.0 Percentage of participants |
Primary
Post-dose 2: Percentage of Participants With 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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Post-dose 2: Percentage of Participants With SAEs | 1 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 2: Percentage of Participants With SAEs | 1 Percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Post-dose 2: Percentage of Participants With Unsolicited AEs | 18.2 Percentage of participants |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Post-dose 2: Percentage of Participants With Unsolicited AEs | 18.9 Percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Baseline | 497 Titers |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Day 29 | 1404 Titers |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Baseline | 539 Titers |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | Day 29 | 1690 Titers |
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | Baseline | 333 EU/L |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | Day 29 | 781 EU/L |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | Baseline | 315 EU/L |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | Day 29 | 814 EU/L |
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | Baseline | 256 EU/L |
| Group 1: Ad26.RSV.preF (1*10^11 vp) Plus Fluarix Then Placebo | RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | Day 29 | 506 EU/L |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | Baseline | 236 EU/L |
| Group 2: Placebo Plus Fluarix Then Ad26.RSV.preF (1*10^11 vp) | RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | Day 29 | 484 EU/L |