Healthy
Conditions
Brief summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
Interventions
BIOLOGICALRSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
OTHERPlacebo
Participants will receive a single IM injection of placebo on Day 1.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3) * A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods * Agree to not donate blood from the time of vaccination until 3 months after vaccination * Have a body mass index (BMI) less than (\<) 40 kilogram per meter square (kg/m\^2) * Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
Exclusion criteria
* Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders) * Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine) * History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis * Has hepatitis B or C infection, including history of treated hepatitis C infection * Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 14 days after vaccination on Day 1 (Day 15) | Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported. |
| Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | Until 7 days after Vaccination on Day 1 (Day 8) | Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | Until 7 days after Vaccination on Day 1 (Day 8) | Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius). |
| Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | Until 28 days after Vaccination on Day 1 (Day 29) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | Until 7 days after vaccination on Day 1 (Day 8) | Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
| Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | Until 7 days after vaccination on Day 1 (Day 8) | Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature \>=38 degree celsius). |
| Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | Until 28 days after vaccination on Day 1 (Day 29) | Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc). |
| Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | At 3 and 6 months after vaccination on Day 1 | Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported. |
| Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | At 14 days and 3 and 6 months after vaccination on Day 1 | RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units. |
| Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | At 14 days and 3 and 6 months after vaccination on Day 1 | T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs). |
| Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | Baseline (Day1 ) up to 6 months | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. |
| Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | At 14 days and 3 and 6 months after vaccination on Day 1 | Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported. |
| Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | At 14 days and 3 and 6 months after vaccination on Day 1 | RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units. |
| Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | At 14 days and 3 and 6 months after vaccination on Day 1 | T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs). |
| Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | Baseline (Day1) up to 6 months | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. |
Countries
United States
Participant flow
Pre-assignment details
A total of 459 participants were enrolled, of which 454 were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1. | 51 |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 51 |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 51 |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 48 |
| Cohort 1: Placebo Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1. | 25 |
| Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 49 |
| Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 49 |
| Cohort 2: Placebo Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1. | 26 |
| Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 27 |
| Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg) Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1. | 51 |
| Cohort 3: Placebo Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1. | 26 |
| Total | 454 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Total | Cohort 3: Placebo | Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2: Placebo | Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Placebo | Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 6.97 | 68.8 years STANDARD_DEVIATION 6.25 | 66.5 years STANDARD_DEVIATION 5.09 | 68.7 years STANDARD_DEVIATION 5.41 | 67.9 years STANDARD_DEVIATION 4.51 | 67.6 years STANDARD_DEVIATION 5.34 | 68.6 years STANDARD_DEVIATION 5.68 | 68.6 years STANDARD_DEVIATION 6.69 | 70 years STANDARD_DEVIATION 6.44 | 70.3 years STANDARD_DEVIATION 6.82 | 69.4 years STANDARD_DEVIATION 6.56 | 68.7 years STANDARD_DEVIATION 7.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 62 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 6 Participants | 11 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 390 Participants | 26 Participants | 48 Participants | 26 Participants | 25 Participants | 46 Participants | 45 Participants | 18 Participants | 37 Participants | 38 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 21 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 2 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 425 Participants | 26 Participants | 49 Participants | 25 Participants | 25 Participants | 45 Participants | 44 Participants | 24 Participants | 46 Participants | 46 Participants | 44 Participants |
| Region of Enrollment UNITED STATES | 51 Participants | 454 Participants | 26 Participants | 51 Participants | 27 Participants | 26 Participants | 49 Participants | 49 Participants | 25 Participants | 48 Participants | 51 Participants | 51 Participants |
| Sex: Female, Male Female | 30 Participants | 247 Participants | 10 Participants | 28 Participants | 16 Participants | 16 Participants | 29 Participants | 17 Participants | 14 Participants | 25 Participants | 30 Participants | 32 Participants |
| Sex: Female, Male Male | 21 Participants | 207 Participants | 16 Participants | 23 Participants | 11 Participants | 10 Participants | 20 Participants | 32 Participants | 11 Participants | 23 Participants | 21 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 0 / 51 | 0 / 48 | 0 / 25 | 0 / 49 | 0 / 49 | 0 / 26 | 0 / 27 | 1 / 51 | 0 / 26 |
| other Total, other adverse events | 42 / 51 | 36 / 51 | 25 / 51 | 23 / 48 | 7 / 25 | 44 / 49 | 48 / 49 | 13 / 26 | 25 / 27 | 44 / 51 | 8 / 26 |
| serious Total, serious adverse events | 3 / 51 | 0 / 51 | 0 / 51 | 1 / 48 | 0 / 25 | 1 / 49 | 1 / 49 | 1 / 26 | 0 / 27 | 2 / 51 | 1 / 26 |
Outcome results
Primary
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Time frame: 14 days after vaccination on Day 1 (Day 15)
Population: Per-protocol Immunogenicity (PPI) set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 4907 EU/L |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 4681 EU/L |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 4038 EU/L |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 5238 EU/L |
| Cohort 1: Placebo | Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination | 272 EU/L |
Primary
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: Until 7 days after Vaccination on Day 1 (Day 8)
Population: Full Analysis Set (FAS) included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 37 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 42 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 3 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 23 Participants |
| Cohort 1: Placebo | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 37 Participants |
| Cohort 3: Placebo | Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 2 Participants |
Primary
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).
Time frame: Until 7 days after Vaccination on Day 1 (Day 8)
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 39 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 43 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 8 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 19 Participants |
| Cohort 1: Placebo | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 41 Participants |
| Cohort 3: Placebo | Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 7 Participants |
Primary
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Time frame: Until 28 days after Vaccination on Day 1 (Day 29)
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 13 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 8 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 7 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 3 Participants |
| Cohort 1: Placebo | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 8 Participants |
| Cohort 3: Placebo | Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 2 Participants |
Secondary
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.
Time frame: At 3 and 6 months after vaccination on Day 1
Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2550 EU/L |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1568 EU/L |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2790 EU/L |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1424 EU/L |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 1940 EU/L |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1247 EU/L |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1834 EU/L |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2997 EU/L |
| Cohort 1: Placebo | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 315 EU/L |
| Cohort 1: Placebo | Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 326 EU/L |
Secondary
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Time frame: Baseline (Day1) up to 6 months
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1: Placebo | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time frame: Until 7 days after vaccination on Day 1 (Day 8)
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 33 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 24 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 15 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 18 Participants |
| Cohort 1: Placebo | Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 0 Participants |
Secondary
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature \>=38 degree celsius).
Time frame: Until 7 days after vaccination on Day 1 (Day 8)
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 35 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 25 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 13 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 15 Participants |
| Cohort 1: Placebo | Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 | 6 Participants |
Secondary
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Time frame: Until 28 days after vaccination on Day 1 (Day 29)
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 11 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 9 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 6 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 5 Participants |
| Cohort 1: Placebo | Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 | 1 Participants |
Secondary
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 6314 Titer |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1760 Titer |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 3760 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 3799 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 5140 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1883 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2777 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 4725 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1473 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 6194 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 2523 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 4413 Titer |
| Cohort 1: Placebo | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 357 Titer |
| Cohort 1: Placebo | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 294 Titer |
| Cohort 1: Placebo | Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 301 Titer |
Secondary
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 3 months after vaccination on Day 1 | 180 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 14 days after vaccination on Day 1 | 547 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 6 months after vaccination on Day 1 | 129 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 14 days after vaccination on Day 1 | 458 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 6 months after vaccination on Day 1 | 189 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 3 months after vaccination on Day 1 | 241 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 14 days after vaccination on Day 1 | 397 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 3 months after vaccination on Day 1 | 168 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 6 months after vaccination on Day 1 | 146 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 6 months after vaccination on Day 1 | 127 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 14 days after vaccination on Day 1 | 404 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 3 months after vaccination on Day 1 | 184 SFC/10^6 PBMCs |
| Cohort 1: Placebo | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 3 months after vaccination on Day 1 | NA SFC/10^6 PBMCs |
| Cohort 1: Placebo | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 14 days after vaccination on Day 1 | NA SFC/10^6 PBMCs |
| Cohort 1: Placebo | Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides | 6 months after vaccination on Day 1 | NA SFC/10^6 PBMCs |
Secondary
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Population: PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 3769 EU/L |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 1982 EU/L |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 3893 EU/L |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 1665 EU/L |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 259 EU/L |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 300 EU/L |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 4278 EU/L |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2696 EU/L |
| Cohort 1: Placebo | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 3856 EU/L |
| Cohort 1: Placebo | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 1864 EU/L |
| Cohort 3: Placebo | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 298 EU/L |
| Cohort 3: Placebo | Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 339 EU/L |
Secondary
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Time frame: Baseline (Day1 ) up to 6 months
Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: Placebo | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Cohort 3: Placebo | Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 3144 Titer |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 4102 Titer |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1983 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2556 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 3552 Titer |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1890 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 356 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 336 Titer |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 371 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 2168 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 3435 Titer |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 4085 Titer |
| Cohort 1: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 1856 Titer |
| Cohort 1: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 3707 Titer |
| Cohort 1: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 2671 Titer |
| Cohort 3: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 342 Titer |
| Cohort 3: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 6 months after vaccination on Day 1 | 356 Titer |
| Cohort 3: Placebo | Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 490 Titer |
Secondary
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
Time frame: At 14 days and 3 and 6 months after vaccination on Day 1
Population: PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 361 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 331 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 435 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 274 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | NA SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | NA SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 236 SFC/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg) | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 131 SFC/10^6 PBMCs |
| Cohort 1: Placebo | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | 204 SFC/10^6 PBMCs |
| Cohort 1: Placebo | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | 172 SFC/10^6 PBMCs |
| Cohort 3: Placebo | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 14 days after vaccination on Day 1 | NA SFC/10^6 PBMCs |
| Cohort 3: Placebo | Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 | 3 months after vaccination on Day 1 | NA SFC/10^6 PBMCs |