Respiratory Syncytial Viruses, Respiratory Tract Infections
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
Detailed description
The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.
Interventions
BIOLOGICALAd26.RSV.preF (1*10^11 vp)
Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
BIOLOGICALAd26.RSV.preF (5*10^10 vp)
RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
DRUGPlacebo
Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Adults Participants: * Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement * 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 local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the United stated (US) Food and Drug Administration (FDA) toxicity tables, 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 * All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a negative urine Beta-hCG pregnancy test immediately prior to each study vaccine administration Pediatric Participants: * Participant is the product of a normal term pregnancy greater than and equal to (\>=) 37 weeks, with a minimum birth weight of 2.5 kilogram (kg) * Participants must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
Exclusion criteria
Adults Participants: * Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature \>=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior to the first dose of study vaccine * Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) Pediatric Participants: * Participant's weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts * Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation: example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | For 7 days after first vaccination on Day 1 (Up to Day 7) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C). |
| Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | For 7 days after second vaccination on Day 29 (Up to Day 35) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C). |
| Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | For 28 days after first vaccination on Day 1 (Up to Day 28) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. |
| Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | For 28 days after second vaccination on Day 29 (Up to Day 56) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary. |
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | For 7 days after first vaccination on Day 1 (Up to Day 7) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. |
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | For 7 days after second vaccination on Day 29 (Up to Day 35) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Pre-fusion on Days 1, 29, 57 and 211 | GMT (ELISA units per liter \[EU/L\]) of RSV F protein in pre-fusion form as assessed by ELISA was reported. |
| Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Post-fusion on Days 1, 29, 57 and 211 | GMT (ELISA units per liter \[EU/L\]) of RSV F protein in post-fusion form as assessed by ELISA was reported. |
| Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Day 1 (predose) and Post-dose on Days, 29, and 57 | Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines. |
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Day 1 (predose), Post-dose on Days 29, 57 and 211 | RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. |
Countries
Finland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF Adult participants aged greater than or equal to (\>=) 18 years to less than or equal to (\<=) 50 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus e pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at dose of 1\*10\^11 viral particles (vp) on Day 1 and Day 29. | 8 |
| Cohort 0 (Adults): Placebo Adult participants aged \>=18 years to \<=50 years received a single IM injection of placebo matching to Ad26.RSV.preF (1\*10\^11 vp) on Day 1 and Day 29. | 4 |
| Cohort 1 (Toddlers): Ad26.RSV.preF Respiratory syncytial virus (RSV) seropositive toddler participants aged \>=12 to \<=24 months received a single IM injection of Ad26.RSV.preF at dose of 5\*10\^10 vp on Day 1 and Day 29. | 24 |
| Cohort 1 (Toddlers): Placebo RSV seropositive toddler participants received a single IM injection of placebo matching to Ad26.RSV.preF (5\*10\^10 vp) on Day 1 and Day 29. | 12 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 0 (Adults): Placebo | Cohort 1 (Toddlers): Ad26.RSV.preF | Cohort 0 (Adults): Ad26.RSV.preF | Cohort 1 (Toddlers): Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 24 Participants | 0 Participants | 12 Participants | 36 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 0 Participants | 8 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 24 Participants | 6 Participants | 11 Participants | 45 Participants |
| Region of Enrollment FINLAND | 0 Participants | 10 Participants | 0 Participants | 5 Participants | 15 Participants |
| Region of Enrollment UNITED KINGDOM | 4 Participants | 13 Participants | 8 Participants | 6 Participants | 31 Participants |
| Region of Enrollment UNITED STATES | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 13 Participants | 6 Participants | 8 Participants | 29 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 2 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 4 | 0 / 24 | 0 / 12 |
| other Total, other adverse events | 6 / 8 | 1 / 4 | 19 / 24 | 10 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 | 1 / 24 | 2 / 12 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | 8 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | 1 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | 14 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination | 4 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | 6 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | 0 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | 14 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination | 4 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).
Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | 8 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | 1 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | 23 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination | 10 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).
Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | 4 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | 1 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | 22 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination | 9 Participants |
Primary
Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Time frame: For 28 days after first vaccination on Day 1 (Up to Day 28)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | 5 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | 0 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | 11 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination | 8 Participants |
Primary
Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Time frame: For 28 days after second vaccination on Day 29 (Up to Day 56)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study vaccine. Here, 'N' (number of participant analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | 4 Participants |
| Cohort 0 (Adults): Placebo | Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | 1 Participants |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | 12 Participants |
| Cohort 1 (Toddlers): Placebo | Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination | 6 Participants |
Secondary
Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.
Time frame: Day 1 (predose) and Post-dose on Days, 29, and 57
Population: PPI set: all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact immunogenicity outcomes. 'N' (number of participants analyzed)=number of participants who were evaluable for this outcome measure, 'n' (number analyzed)=number of participants evaluable at specified timepoint and '0' in number analyzed field=none of participants were applicable for evaluation at specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 29 | 0.003 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 29 | 0.098 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 1 | 0.045 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 29 | 0.145 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 29 | 0.168 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 57 | 0.081 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 1 | 0.058 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 1 | 0.006 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 57 | 0.112 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 57 | 0.148 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 57 | 0.003 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 1 | 0.041 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 57 | 0.062 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 1 | 0.054 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 29 | 0.058 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 57 | 0.039 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 1 | 0.075 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 29 | 0.092 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 57 | 0.001 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 1 | 0.054 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 29 | 0.049 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 57 | 0.039 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 1 | 0.001 Percentage of cytokine cell subsets |
| Cohort 0 (Adults): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 29 | 0.001 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 29 | 0.034 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 1 | 0.002 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 1 | 0.033 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 29 | 0.077 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 1 | 0.030 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 29 | 0.005 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 29 | 0.089 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 1 | 0.007 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 29 | 0.003 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 29 | 0.028 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 29 | 0.074 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th1: Day 1 | 0.018 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 29 | 0.053 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | Th2: Day 1 | 0.004 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD8: Day 1 | 0.041 Percentage of cytokine cell subsets |
| Cohort 1 (Toddlers): Placebo | Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57 | CD4: Day 1 | 0.050 Percentage of cytokine cell subsets |
Secondary
Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
GMT (ELISA units per liter \[EU/L\]) of RSV F protein in post-fusion form as assessed by ELISA was reported.
Time frame: Post-fusion on Days 1, 29, 57 and 211
Population: The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 1 | 196 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 29 | 328 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 57 | 341 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 211 | 268 EU/L |
| Cohort 0 (Adults): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 29 | 207 EU/L |
| Cohort 0 (Adults): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 57 | 179 EU/L |
| Cohort 0 (Adults): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 211 | 181 EU/L |
| Cohort 0 (Adults): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 1 | 191 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 57 | 863 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 29 | 686 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 211 | 420 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 1 | 77 EU/L |
| Cohort 1 (Toddlers): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 211 | 91 EU/L |
| Cohort 1 (Toddlers): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 29 | 86 EU/L |
| Cohort 1 (Toddlers): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 1 | 94 EU/L |
| Cohort 1 (Toddlers): Placebo | Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211 | Day 57 | 109 EU/L |
Secondary
Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
GMT (ELISA units per liter \[EU/L\]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.
Time frame: Pre-fusion on Days 1, 29, 57 and 211
Population: The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 1 | 197 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 29 | 441 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 57 | 481 EU/L |
| Cohort 0 (Adults): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 211 | 418 EU/L |
| Cohort 0 (Adults): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 29 | 261 EU/L |
| Cohort 0 (Adults): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 57 | 244 EU/L |
| Cohort 0 (Adults): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 211 | 292 EU/L |
| Cohort 0 (Adults): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 1 | 249 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 57 | 1918 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 29 | 1174 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 211 | 924 EU/L |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 1 | 59 EU/L |
| Cohort 1 (Toddlers): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 211 | 120 EU/L |
| Cohort 1 (Toddlers): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 29 | 106 EU/L |
| Cohort 1 (Toddlers): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 1 | 113 EU/L |
| Cohort 1 (Toddlers): Placebo | Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211 | Day 57 | 148 EU/L |
Secondary
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Time frame: Day 1 (predose), Post-dose on Days 29, 57 and 211
Population: The Per-protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available, excluding participant samples with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies the number of participants evaluable at a specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 0 (Adults): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Day 1 (pre-dose) | 329 Titers |
| Cohort 0 (Adults): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 1: Day 29 | 1089 Titers |
| Cohort 0 (Adults): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 57 | 926 Titers |
| Cohort 0 (Adults): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 211 | 704 Titers |
| Cohort 0 (Adults): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 1: Day 29 | 603 Titers |
| Cohort 0 (Adults): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 57 | 566 Titers |
| Cohort 0 (Adults): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 211 | 574 Titers |
| Cohort 0 (Adults): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Day 1 (pre-dose) | 547 Titers |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 57 | 2235 Titers |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 1: Day 29 | 1608 Titers |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 211 | 1164 Titers |
| Cohort 1 (Toddlers): Ad26.RSV.preF | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Day 1 (pre-dose) | 121 Titers |
| Cohort 1 (Toddlers): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 211 | 165 Titers |
| Cohort 1 (Toddlers): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 1: Day 29 | 156 Titers |
| Cohort 1 (Toddlers): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Day 1 (pre-dose) | 187 Titers |
| Cohort 1 (Toddlers): Placebo | Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211 | Post dose 2: Day 57 | 198 Titers |