Respiratory Syncytial Virus
Conditions
Brief summary
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.
Detailed description
RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.
Interventions
BIOLOGICALPlacebo
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
BIOLOGICALAd26.RSV.preF
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.
BIOLOGICALNimenrix
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM 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
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days prior to dosing * Participant is the product of a normal term pregnancy greater than or equal to (\>=)37 weeks, with a minimum birth weight of 2.5 kilogram (kg) * Participant must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening * Participant has received all routine immunizations appropriate for his or her age according to local guidelines * Each participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer
Exclusion criteria
* Participant's weight is below tenth percentile according to World Health Organization (WHO) pediatric growth and weight charts * Participant has any clinically significant acute or chronic medical condition (for 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 beta 2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation * Participant is in receipt of, or planning to receive, live attenuated vaccine (for example, measles, mumps and rubella \[MMR\] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (that is, before and after); other vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination * Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection * Participant has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Participants with egg allergies can be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Up to 2 year 10 months | Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination | Up to Day 36 (7 days after second vaccination on Day 29) | An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. |
| Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Up to Day 64 (7 days after third vaccination on Day 57) | An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. |
| Number of Participants With Unsolicited AEs for 28 Days After First Vaccination | Up to Day 29 (28 days after first vaccination on Day 1) | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. |
| Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination | Up to Day 57 (28 days after second vaccination on Day 29) | An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. |
| Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination | Up to Day 85 (28 days after third vaccination on Day 57) | An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary. |
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination | Up to Day 8 (7 days after first vaccination on Day 1) | An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Days 1, 8, 85, and 267 (End of first RSV season) | Pre-fusion A IgG serum antibody response was assessed by ELISA. |
| Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Days 1, 8, 85, and 267 (End of first RSV season) | Post-fusion A IgG serum antibody response as assessed by ELISA was reported. |
| T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry | Baseline (Day 1) and Day 85 | T-cell response (%) to RSV F peptides for T-helper Th1 and Th2 subtyping as measured by flow cytometry was planned to be assessed. Th1(% of Clusters of differentiation 4 \[CD4\]+ interferon gamma \[IFN-g\]+T cells; lower limit(s) of quantification \[LLOQ\]=0.05%) and Th2 (% of CD4+ interleukin \[IL\]-4+/IL-13+ and CD40L+T cells; LLOQ=0.07%) responses were determined by intracellular cytokines after RSV F peptide stimulation. |
| Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI) | Up to 2 year 10 months | Number of participants with severe RSV-LRTI were reported. |
| Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Days 1, 8, 85, and 267 (End of first RSV season) | Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units. |
Countries
Australia, Brazil, Canada, Finland, Poland, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Nimenrix Respiratory syncytial virus (RSV) seronegative toddler participants aged greater than or equal to (\>=) 12 months to less than or equal to (\<=) 24 months received placebo (matching to Ad26.RSV.preF) as an intramuscular (IM) injection on Days 1, 29 and 57. For participants in whose countries the commercial vaccine Nimenrix was licensed, placebo was replaced with Nimenrix as IM injection on Day 57 in accordance with local label and local regulations and based on joint parent/legal guardian and principal investigator (PI) decision. | 18 |
| Ad26.RSV.preF RSV seronegative toddler participants aged \>=12 months to \<=24 months received Ad26.RSV.preF (0.25 mL of 2.5\*10\^10 viral particles \[vp\]) as an IM injection on Days 1, 29, and 57. | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | 'moved from study area | 0 | 1 |
Baseline characteristics
| Characteristic | Ad26.RSV.preF | Placebo/Nimenrix | Total |
|---|---|---|---|
| Age, Continuous | 15 months | 18.5 months | 16.5 months |
| Age, Customized From 12 months to 24 months | 20 Participants | 18 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 16 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 13 Participants | 29 Participants |
| Region of Enrollment AUSTRALIA | 8 Participants | 6 Participants | 14 Participants |
| Region of Enrollment BRAZIL | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment CANADA | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment FINLAND | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment POLAND | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 | 0 / 20 |
| other Total, other adverse events | 6 / 6 | 8 / 12 | 15 / 20 |
| serious Total, serious adverse events | 0 / 6 | 0 / 12 | 1 / 20 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 2 year 10 months
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations. Data for this outcome measure was planned to be collected and analyzed per the administered study vaccination type.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Nimenrix | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Ad26.RSV.preF | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Ad26.RSV.preF | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Time frame: Up to Day 8 (7 days after first vaccination on Day 1)
Population: The Full Analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination | Solicited Local AEs | 2 Participants |
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination | Solicited Systemic AEs | 11 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination | Solicited Local AEs | 6 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination | Solicited Systemic AEs | 17 Participants |
Primary
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Time frame: Up to Day 36 (7 days after second vaccination on Day 29)
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination | Solicited Local AEs | 1 Participants |
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination | Solicited Systemic AEs | 9 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination | Solicited Local AEs | 9 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination | Solicited Systemic AEs | 11 Participants |
Primary
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Time frame: Up to Day 64 (7 days after third vaccination on Day 57)
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations. Here, 'N' (Number of participants analyzed) included number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed per the administered study vaccination type.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Local AEs | 1 Participants |
| Placebo/Nimenrix | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Systemic AEs | 3 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Local AEs | 4 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Systemic AEs | 4 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Local AEs | 7 Participants |
| Ad26.RSV.preF | Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination | Solicited Systemic AEs | 12 Participants |
Primary
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Time frame: Up to Day 29 (28 days after first vaccination on Day 1)
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Nimenrix | Number of Participants With Unsolicited AEs for 28 Days After First Vaccination | 5 Participants |
| Ad26.RSV.preF | Number of Participants With Unsolicited AEs for 28 Days After First Vaccination | 9 Participants |
Primary
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Time frame: Up to Day 57 (28 days after second vaccination on Day 29)
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Nimenrix | Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 7 Participants |
| Ad26.RSV.preF | Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 9 Participants |
Primary
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Time frame: Up to Day 85 (28 days after third vaccination on Day 57)
Population: The FAS included all participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations. Here, 'N' (Number of participants analyzed) included number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed per the administered study vaccination type.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Nimenrix | Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 7 Participants |
| Ad26.RSV.preF | Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 3 Participants |
| Ad26.RSV.preF | Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 3 Participants |
Secondary
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
Number of participants with severe RSV-LRTI were reported.
Time frame: Up to 2 year 10 months
Population: The Modified Intent-to-treat (mITT) analysis set included participants who were randomized and received at least one dose of study vaccine (placebo or nimenrix, and Ad26.RSV.preF), regardless of the occurrence of protocol deviations and who seronegative at screening but for whom there is an anamnestic response at Day 8.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Nimenrix | Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI) | 0 Participants |
| Ad26.RSV.preF | Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI) | 0 Participants |
Secondary
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
Post-fusion A IgG serum antibody response as assessed by ELISA was reported.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Population: The PPI analysis set included all randomized and vaccinated participants for whom immunogenicity data are available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) is number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo/Nimenrix | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 1 | NA EU/L |
| Placebo/Nimenrix | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 8 | NA EU/L |
| Placebo/Nimenrix | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 85 | NA EU/L |
| Placebo/Nimenrix | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 267 (End of first RSV season) | NA EU/L |
| Ad26.RSV.preF | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 267 (End of first RSV season) | 58 EU/L |
| Ad26.RSV.preF | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 1 | NA EU/L |
| Ad26.RSV.preF | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 85 | 47 EU/L |
| Ad26.RSV.preF | Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA | Day 8 | NA EU/L |
Secondary
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Pre-fusion A IgG serum antibody response was assessed by ELISA.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Population: The PPI analysis set included all randomized and vaccinated participants for whom immunogenicity data are available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) included number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo/Nimenrix | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 1 | NA ELISA units per liter (EU/L) |
| Placebo/Nimenrix | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | NA ELISA units per liter (EU/L) |
| Placebo/Nimenrix | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | NA ELISA units per liter (EU/L) |
| Placebo/Nimenrix | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 267 (End of first RSV season) | NA ELISA units per liter (EU/L) |
| Ad26.RSV.preF | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 267 (End of first RSV season) | 212 ELISA units per liter (EU/L) |
| Ad26.RSV.preF | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 1 | NA ELISA units per liter (EU/L) |
| Ad26.RSV.preF | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 236 ELISA units per liter (EU/L) |
| Ad26.RSV.preF | Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | NA ELISA units per liter (EU/L) |
Secondary
T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
T-cell response (%) to RSV F peptides for T-helper Th1 and Th2 subtyping as measured by flow cytometry was planned to be assessed. Th1(% of Clusters of differentiation 4 \[CD4\]+ interferon gamma \[IFN-g\]+T cells; lower limit(s) of quantification \[LLOQ\]=0.05%) and Th2 (% of CD4+ interleukin \[IL\]-4+/IL-13+ and CD40L+T cells; LLOQ=0.07%) responses were determined by intracellular cytokines after RSV F peptide stimulation.
Time frame: Baseline (Day 1) and Day 85
Population: Data for this outcome measure was not collected due to low number of viable peripheral blood mononuclear cells (PBMC), the positive control in the intracellular cytokine staining (ICS) assay (Staphylococcal enterotoxin B \[SEB\]) could not be performed.
Secondary
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Population: The Per-protocol Immunogenicity (PPI) analysis set included all randomized and vaccinated participants for whom immunogenicity data are available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) included number of participants evaluable for specified time points. Here, values below the seropositivity cut-off (less than \[\<\] 42.7) were imputed with zero.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo/Nimenrix | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 1 | NA Titers |
| Placebo/Nimenrix | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 8 | NA Titers |
| Placebo/Nimenrix | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 85 | NA Titers |
| Placebo/Nimenrix | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 267 (End of first RSV season) | NA Titers |
| Ad26.RSV.preF | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 267 (End of first RSV season) | 269 Titers |
| Ad26.RSV.preF | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 1 | NA Titers |
| Ad26.RSV.preF | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 85 | 293 Titers |
| Ad26.RSV.preF | Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain | Day 8 | NA Titers |