Healthy
Conditions
Brief summary
The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Interventions
BIOLOGICALPlacebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
BIOLOGICALRSV preF Protein 50 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
BIOLOGICALRSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
BIOLOGICALAd26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
BIOLOGICALMixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
BIOLOGICALMixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
BIOLOGICALMixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
BIOLOGICALMixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
BIOLOGICALSelected Regimen
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods * In the investigator's clinical judgment, participant 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 symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks 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 at screening * For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator * From the time of each vaccination through 3 months after each vaccination, 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
* Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively * Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection * Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures * Participant has a 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) * Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | Day 29 | RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | 7 days post-vaccination 2 on Day 57 (Day 64) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | 7 days post-vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | 7 days post-vaccination 2 on Day 365 (Day 372) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | 7 days post-vaccination 3 on Day 730 (Day 737) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 28 days post-vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 28 days post-vaccination 2 on Day 57 (Day 85) | Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 28 days post-vaccination 3 on Day 365 (Day 393) | Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 28 days post-vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 28 days post-vaccination 2 on Day 57 (Day 85) | Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 28 days post-vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 28 days post-vaccination 2 on Day 365 (Day 393) | Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 28 days post-vaccination 3 on Day 730 (Day 758) | Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Day 730 | An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Day 730 | An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Day 1095 | An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Day 1095 | An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | 7 days post-vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | 7 days post-vaccination 2 on Day 57 (Day 64) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | 7 days post-vaccination 3 on Day 365 (Day 372) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | 7 days post-vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758 | RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. |
| Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29 | Day 29 | RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only. |
| Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85 | Day 85 | RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only. |
| Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, and 547 | GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported. |
| Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, and 547 | GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported. |
| Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, and 547 | GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported. |
| Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, and 547 | GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported. |
| Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, and 547 | Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10\^6 peripheral blood mononuclear cells (PBMCs). |
| Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758 | Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10\^6 PBMCs. |
| Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | Day 29 | Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85 | Day 85 | Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only. |
| Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Days 1, 15, 29, 57, 85, 183, 365, 393, and 547 | RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Pooled Placebo Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57. | 16 |
| Cohort 1: RSV preF Protein 50 mcg Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1. | 8 |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5\*10\^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1. | 8 |
| Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1. | 8 |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\*10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1. | 8 |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1. | 8 |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\*10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1. | 8 |
| Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\*10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2. | 24 |
| Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\*10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2. | 42 |
| Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2. | 42 |
| Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2. | 42 |
| Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\*10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2. | 42 |
| Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\*10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2. | 36 |
| Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2. | 36 |
| Cohort 2: Pooled Placebo Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2. | 24 |
| Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3. | 135 |
| Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\*10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3. | 136 |
| Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3. | 44 |
| Total | 667 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Initiated Prohibited Medication | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 2 | 1 | 2 | 1 | 1 | 0 | 4 | 9 | 2 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 4 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Randomized but not vaccinated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Sponsor's Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 3 | 1 | 2 | 12 | 23 | 5 | 3 | 3 | 43 | 44 | 18 |
Baseline characteristics
| Characteristic | Cohort 1: Pooled Placebo | Total | Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen | Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo | Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pooled Placebo | Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone | Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone | Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone | Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone | Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone | Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV preF Protein 50 mcg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.22 | 68.3 years STANDARD_DEVIATION 6.4 | 69.3 years STANDARD_DEVIATION 6.12 | 68.4 years STANDARD_DEVIATION 6.25 | 67.9 years STANDARD_DEVIATION 6.43 | 69 years STANDARD_DEVIATION 7.08 | 66.5 years STANDARD_DEVIATION 5.03 | 69 years STANDARD_DEVIATION 6.49 | 71 years STANDARD_DEVIATION 7.58 | 67.5 years STANDARD_DEVIATION 5.71 | 68.5 years STANDARD_DEVIATION 6.96 | 69 years STANDARD_DEVIATION 6.9 | 68.5 years STANDARD_DEVIATION 6.29 | 66.1 years STANDARD_DEVIATION 6.17 | 64.5 years STANDARD_DEVIATION 3.78 | 67.3 years STANDARD_DEVIATION 3.88 | 69.4 years STANDARD_DEVIATION 6.23 | 67.4 years STANDARD_DEVIATION 6.21 | 67 years STANDARD_DEVIATION 6.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 38 Participants | 1 Participants | 9 Participants | 3 Participants | 4 Participants | 1 Participants | 4 Participants | 3 Participants | 6 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 628 Participants | 43 Participants | 127 Participants | 132 Participants | 20 Participants | 35 Participants | 32 Participants | 39 Participants | 36 Participants | 39 Participants | 41 Participants | 22 Participants | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 7 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 13 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 62 Participants | 0 Participants | 16 Participants | 11 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 | 12 Participants | 581 Participants | 41 Participants | 117 Participants | 121 Participants | 21 Participants | 31 Participants | 34 Participants | 36 Participants | 38 Participants | 40 Participants | 37 Participants | 20 Participants | 4 Participants | 3 Participants | 7 Participants | 7 Participants | 8 Participants | 4 Participants |
| Region of Enrollment UNITED STATES | 16 Participants | 667 Participants | 44 Participants | 136 Participants | 135 Participants | 24 Participants | 36 Participants | 36 Participants | 42 Participants | 42 Participants | 42 Participants | 42 Participants | 24 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 8 Participants | 400 Participants | 24 Participants | 78 Participants | 83 Participants | 13 Participants | 28 Participants | 20 Participants | 27 Participants | 28 Participants | 27 Participants | 24 Participants | 13 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 267 Participants | 20 Participants | 58 Participants | 52 Participants | 11 Participants | 8 Participants | 16 Participants | 15 Participants | 14 Participants | 15 Participants | 18 Participants | 11 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 4 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 | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 8 | 0 / 8 | 1 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 24 | 1 / 42 | 1 / 42 | 0 / 42 | 0 / 42 | 1 / 36 | 0 / 36 | 0 / 24 | 1 / 135 | 0 / 136 | 0 / 44 |
| other Total, other adverse events | 5 / 16 | 5 / 8 | 2 / 8 | 2 / 8 | 4 / 8 | 6 / 8 | 4 / 8 | 12 / 24 | 14 / 42 | 14 / 42 | 15 / 42 | 10 / 42 | 10 / 36 | 15 / 36 | 10 / 24 | 25 / 135 | 27 / 136 | 13 / 44 |
| serious Total, serious adverse events | 3 / 16 | 0 / 8 | 0 / 8 | 2 / 8 | 3 / 8 | 0 / 8 | 0 / 8 | 0 / 24 | 5 / 42 | 5 / 42 | 4 / 42 | 5 / 42 | 7 / 36 | 3 / 36 | 4 / 24 | 14 / 135 | 16 / 136 | 3 / 44 |
Outcome results
Primary
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Time frame: From Day 1 up to Day 730
Population: The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 3 Participants |
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 4 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 2 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 0 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 4 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 4 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 0 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 1 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 4 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 6 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 6 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 5 Participants |
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 5 Participants |
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 5 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 1 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 0 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 1 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 2 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 4 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 7 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 0 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 1 Participants |
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 3 on Day 365 (Day 372)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 1 Participants |
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 2 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 0 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 1 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 0 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 2 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 2 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 4 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 0 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 6 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 3 Participants |
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 2 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 5 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 0 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 1 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 3 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 4 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 3 Participants |
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 2 on Day 57 (Day 85)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 2 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 1 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 2 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 0 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 2 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 4 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 0 Participants |
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 3 on Day 365 (Day 393)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 1 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 0 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 0 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 1 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 0 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 1 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 1 Participants |
Primary
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.
Time frame: Day 29
Population: The per-protocol RSV immunogenicity (PPI) set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | 1642 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | 2869 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | 4813 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | 5189 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29 | 4855 Titers |
Primary
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Time frame: From Day 1 up to Day 730
Population: The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
Primary
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Time frame: From Day 1 up to Day 1095
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
Primary
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 14 Participants |
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 11 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 24 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 23 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 26 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 20 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 29 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 22 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 25 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 21 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 20 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 20 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 20 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 22 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 5 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 11 Participants |
Primary
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 3 Participants |
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 1 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 0 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 9 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 8 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 7 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 3 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 2 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 5 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 13 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 23 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 6 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 2 Participants |
Primary
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 8 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 11 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 10 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 12 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 8 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 10 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 12 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 3 Participants |
Primary
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 2 on Day 57 (Day 85)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 6 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 5 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 5 Participants |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 6 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 2 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 3 Participants |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 5 Participants |
| Cohort 2: Pooled Placebo | Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 8 Participants |
Primary
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
An AE is 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. An 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Time frame: From Day 1 up to Day 1095
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 14 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 16 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 95 Participants |
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 95 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 94 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 88 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Local AEs | 9 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 | Solicited Systemic AEs | 12 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 2 on Day 365 (Day 372)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 74 Participants |
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 56 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 23 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 38 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Local AEs | 6 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 | Solicited Systemic AEs | 10 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 3 on Day 730 (Day 737)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 42 Participants |
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 32 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 48 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 46 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Local AEs | 4 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 | Solicited Systemic AEs | 6 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 1 on Day 1 (Day 29)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 32 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 23 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1 | 7 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 2 on Day 365 (Day 393)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 9 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 10 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2 | 4 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is 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 are all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post-vaccination 3 on Day 730 (Day 758)
Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 8 Participants |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 8 Participants |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3 | 2 Participants |
Secondary
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10\^6 peripheral blood mononuclear cells (PBMCs).
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 42 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 61 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 46 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 52 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 54 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 56 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 42 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 57 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 48 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 105 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 199 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 199 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 341 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 159 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 211 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 39 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 152 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 78 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 270 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 398 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 16 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 432 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 281 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 492 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 180 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 183 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 262 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 172 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 26 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 316 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 153 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 130 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 293 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 158 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 472 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 245 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 720 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 244 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 71 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 271 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 556 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 374 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 297 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 301 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 390 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 399 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 167 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 400 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 34 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 231 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 271 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 432 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 202 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 305 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 480 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 215 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 416 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 249 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 315 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 443 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 56 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 258 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 274 SFU/10^6 PBMCs |
Secondary
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 217 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 226 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 214 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 220 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 237 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 254 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 243 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 194 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 222 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 710 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1020 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 607 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 1208 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 874 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 986 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 206 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 225 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1164 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1316 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2122 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 316 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 4841 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1827 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 2385 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 3098 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3929 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1382 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1163 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 197 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2985 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2303 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 964 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1906 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 657 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1631 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 863 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1408 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 864 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 210 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1698 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1332 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 723 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 530 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 844 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 3032 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 1739 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 866 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1330 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 239 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 740 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1499 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1384 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1001 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 857 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 973 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 547 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1033 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 398 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 693 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1140 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 159 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 792 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 786 EU/L |
Secondary
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 246 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 271 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 219 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 268 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 333 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 281 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 304 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 261 EU/L |
| Cohort 1: Pooled Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 245 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1045 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2048 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 952 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2144 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1259 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1697 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 263 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 365 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1694 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1669 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 3768 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 360 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 6121 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 2105 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 3523 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 4715 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 4132 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 2486 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1715 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 215 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 4315 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3352 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 3450 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 3996 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 993 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 2856 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1813 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 2796 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 3469 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 274 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3575 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 3215 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1304 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1192 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1415 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 6268 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 3507 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2339 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 2970 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 301 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1415 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2396 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2672 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 2241 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1654 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 3396 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1095 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2257 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 928 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2145 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 393 | 1952 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 242 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1879 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1688 EU/L |
Secondary
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 431 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 502 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 412 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 536 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 442 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 529 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 637 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 197 Titers |
| Cohort 1: Pooled Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 553 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 2473 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 4142 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 2149 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 4850 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 2548 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 3326 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 600 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 595 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 3441 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 2628 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 4865 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 917 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 823 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 3889 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 11814 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 5105 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 5716 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 4613 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 2444 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 434 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 644 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 4311 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 3382 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 4574 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 1395 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 3468 Titers |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 2286 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 3103 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 5276 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 457 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 5933 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 4582 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 2359 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 2531 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 3438 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 1152 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 4404 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 3382 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 2994 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 577 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 2039 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 2399 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 4667 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 4080 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 2759 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 7782 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 2073 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 3678 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 1665 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 3980 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 3081 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 522 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 3548 Titers |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 3905 Titers |
Secondary
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Time frame: Day 29
Population: The PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 320 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 354 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 315 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 290 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 390 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29 | 298 SFU/10^6 PBMCs |
Secondary
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Time frame: Day 29
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29 | 6053 Titers |
Secondary
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Time frame: Day 85
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85 | 495 SFU/10^6 PBMCs |
Secondary
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Time frame: Day 85
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85 | 4616 Titers |
Secondary
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 270 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 679 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 513 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 455 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 634 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 381 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 409 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 612 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 507 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1542 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 735 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1144 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 666 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 1785 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1403 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 260 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 727 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1239 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 1555 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 228 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1050 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 556 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 605 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1233 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2195 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 896 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 652 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2524 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 640 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1754 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 202 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1397 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 785 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2203 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 237 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2617 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 908 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1400 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 741 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1740 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 246 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 570 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2159 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1863 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1506 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1088 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 709 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 660 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1504 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1661 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 1994 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 2365 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 234 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 720 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 755 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 924 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 241 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 190 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 181 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 219 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 257 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 166 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 232 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 222 EU/L |
Secondary
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 912 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 1239 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 436 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 1052 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1028 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 699 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 612 EU/L |
| Cohort 1: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 554 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2031 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2796 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1086 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1027 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 354 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2397 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 3860 EU/L |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 775 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 868 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1824 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 779 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 2435 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1121 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2150 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 278 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 3363 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 946 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 6055 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 274 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2977 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3880 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2553 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1369 EU/L |
| Cohort 1: RSV preF Protein 150 mcg | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 990 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2853 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1105 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3610 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 318 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 937 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2400 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1320 EU/L |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture) | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 5375 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 849 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 4925 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3318 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 314 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 917 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1083 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 1981 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2521 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 3684 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 5215 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 2903 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 2686 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 1561 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 1072 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 1230 EU/L |
| Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 326 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 547 | 264 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 183 | 251 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 85 | 289 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 57 | 290 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 29 | 234 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 15 | 217 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 1 | 229 EU/L |
| Cohort 2: Pooled Placebo | Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints | Day 365 | 204 EU/L |
Secondary
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10\^6 PBMCs.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 56 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 515 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 348 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 371 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 301 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 218 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 152 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 364 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 284 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 730 | 210 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 744 | 707 SFU/10^6 PBMCs |
| Cohort 1: Pooled Placebo | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 758 | 390 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 758 | 430 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 73 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 233 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 233 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 566 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 227 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 744 | 651 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 457 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 207 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 327 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 424 SFU/10^6 PBMCs |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 730 | 243 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 57 | 41 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 85 | 18 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 730 | 25 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 183 | 32 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 365 | 44 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 393 | 30 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 744 | 35 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 1 | 39 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 15 | 17 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 547 | 17 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 29 | 46 SFU/10^6 PBMCs |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints | Day 758 | 14 SFU/10^6 PBMCs |
Secondary
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Time frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 6739 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 3765 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 4412 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 744 | 2116 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 3220 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 546 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 730 | 1051 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 2021 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 758 | 2201 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 5808 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 2856 Titers |
| Cohort 1: Pooled Placebo | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 1743 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 1741 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 1364 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 730 | 841 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 744 | 2473 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 3891 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 758 | 2315 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 3252 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 4982 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 2829 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 552 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 1895 Titers |
| Cohort 1: RSV preF Protein 50 mcg | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 4338 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 183 | 673 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 1 | 582 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 15 | 525 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 29 | 489 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 57 | 563 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 85 | 514 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 758 | 416 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 365 | 545 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 393 | 585 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 547 | 469 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 730 | 314 Titers |
| Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture) | Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints | Day 744 | 393 Titers |