Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Conditions
Brief summary
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.
Detailed description
RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.
Interventions
BIOLOGICALRSV preF-based Vaccine
RSV preF-based vaccine will be administered as intramuscular injection.
DRUGPlacebo
Placebo will be administered as intramuscular injection.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* In the investigator's clinical judgment, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), Type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. * Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination * 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 laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States Food and Drug Administration (US FDA) toxicity tables (that is, for tests in the FDA table), 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 * Agrees not to donate blood from the time of vaccination through 3 months after vaccination * Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion criteria
* History of malignancy within 5 years before screening not in the following categories: a) Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) Participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled * Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components * Per medical history, participant has chronic active hepatitis B or hepatitis C infection, human immunodeficiency viruses (HIV) type 1 or type 2 infection, acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy * Participant is in receipt of, or planning to receive, licensed live attenuated vaccine within 28 days before and after study vaccinations; other licensed vaccines (that is, not live such as, influenza, tetanus, hepatitis A or B, rabies) within 14 days before and after study vaccinations * Received treatment with immunoglobulins expected to impact the vaccine-induced immune response (including monoclonal antibodies \[MAbs\] for chronic underlying conditions) in the 2 months; immunoglobulins specific to respiratory syncytial virus (RSV), human metapneumovirus, or parainfluenza viruses in the 12 months; apheresis therapies in the 4 months; or blood products in the 4 months prior to study vaccination or has any plans to receive such treatment during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to 6 months post vaccination (up to Day 183) | 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. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | From Day 1 up to 6 months post vaccination (up to Day 183) | Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs. |
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | 7 days post vaccination (Day 8) | Number of participants with solicited local and systemic AEs 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). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were 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). |
| Number of Participants With Unsolicited Adverse Events (AEs) | 28 days post vaccination (Day 29) | Number of participants with unsolicited AEs 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 were not specifically questioned in the participant diary. |
Countries
United States
Participant flow
Pre-assignment details
Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1. | 12 |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1. | 12 |
| Arm 1c (Cohort 1): Pooled Placebo Participants received a single IM injection of placebo on Day 1. | 12 |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1. | 12 |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 12 |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 12 |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1. | 11 |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 11 |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 11 |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1. | 12 |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1. | 12 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Randomized but not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 11 | 12 | 12 | 12 | 11 | 11 | 11 | 11 | 11 | 11 | 12 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Total | Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Arm 1c (Cohort 1): Pooled Placebo | Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 5.42 | 66.9 years STANDARD_DEVIATION 4.76 | 65.5 years STANDARD_DEVIATION 3.78 | 65.4 years STANDARD_DEVIATION 4.4 | 66.3 years STANDARD_DEVIATION 3.04 | 64.8 years STANDARD_DEVIATION 4.14 | 68.5 years STANDARD_DEVIATION 6.12 | 67.4 years STANDARD_DEVIATION 4.83 | 65.7 years STANDARD_DEVIATION 4.94 | 69.3 years STANDARD_DEVIATION 3.39 | 66.2 years STANDARD_DEVIATION 5.65 | 67.8 years STANDARD_DEVIATION 5.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 7 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 122 Participants | 10 Participants | 11 Participants | 11 Participants | 9 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 18 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 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) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 109 Participants | 10 Participants | 10 Participants | 10 Participants | 8 Participants | 8 Participants | 10 Participants | 10 Participants | 10 Participants | 11 Participants | 10 Participants |
| Region of Enrollment UNITED STATES | 12 Participants | 129 Participants | 12 Participants | 12 Participants | 11 Participants | 11 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Female | 9 Participants | 77 Participants | 5 Participants | 6 Participants | 7 Participants | 9 Participants | 6 Participants | 6 Participants | 6 Participants | 10 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 52 Participants | 7 Participants | 6 Participants | 4 Participants | 2 Participants | 5 Participants | 6 Participants | 6 Participants | 2 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 11 / 12 | 9 / 12 | 10 / 12 | 10 / 12 | 10 / 12 | 11 / 12 | 8 / 11 | 11 / 11 | 10 / 11 | 11 / 12 | 8 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 1 / 12 | 1 / 12 | 0 / 12 | 0 / 12 | 1 / 11 | 1 / 11 | 1 / 11 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 1c (Cohort 1): Pooled Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 1 Participants |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 1 Participants |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
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.
Time frame: From Day 1 up to 6 months post vaccination (up to Day 183)
Population: The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Arm 1c (Cohort 1): Pooled Placebo | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Number of participants with solicited local and systemic AEs 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). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were 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 (Day 8)
Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 6 Participants |
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 9 Participants |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 8 Participants |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 8 Participants |
| Arm 1c (Cohort 1): Pooled Placebo | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 5 Participants |
| Arm 1c (Cohort 1): Pooled Placebo | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 7 Participants |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 7 Participants |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 8 Participants |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 8 Participants |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 9 Participants |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 10 Participants |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 10 Participants |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 7 Participants |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 7 Participants |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 8 Participants |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 10 Participants |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 9 Participants |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 10 Participants |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 11 Participants |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 10 Participants |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 7 Participants |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 7 Participants |
Primary
Number of Participants With Unsolicited Adverse Events (AEs)
Number of participants with unsolicited AEs 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 were not specifically questioned in the participant diary.
Time frame: 28 days post vaccination (Day 29)
Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 5 Participants |
| Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 2 Participants |
| Arm 1c (Cohort 1): Pooled Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 4 Participants |
| Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 3 Participants |
| Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 4 Participants |
| Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 0 Participants |
| Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 2 Participants |
| Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 1 Participants |
| Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 4 Participants |
| Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 5 Participants |
| Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 2 Participants |