Healthy
Conditions
Keywords
Respiratory syncytial virus (RSV), Human metapneumovirus (hMPV), Bivalent virus-like particle protein subunit vaccine
Brief summary
The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.
Detailed description
The IVX-A12 Phase 2a clinical trial is a randomized, observer-blind, placebo-controlled, dosage optimization, multi-center trial to evaluate the safety and immunogenicity of a single intramuscular (IM) dose of IVX-A12, with or without adjuvant, in adults 60 to 85 years of age. Participants will be administered a single shot of IVX-A12, at specified dosage levels, or placebo. The overall duration of the study is up to 1 year (12 months). A subset of participants will be followed for an additional 12 months for a total duration of 24 months.
Interventions
BIOLOGICALIVX-A12
IVX-A12 without adjuvant
BIOLOGICALPlacebo
Diluent
Sponsors
Icosavax, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants, who must be in stable health based on medical history, vital signs, physical examination, and laboratory evaluation prior to vaccination, in the investigator's clinical judgment 2. Participants may have ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) who are, in the investigator's opinion, medically compensated and without recent exacerbation within the prior 3 months 3. Participants able to voluntarily give written informed consent and can comply with trial procedures including follow-up for approximately 12 months after vaccination 4. Body mass index 17 to less than (\<) 40 kilograms per square meter (kg/m\^2) at screening 5. Before randomization, female participants must be unable to conceive (example, menopausal, that is, 12 consecutive months without menstruation, hysterectomy, oophorectomy, etc.) and not intending to conceive by any method 6. Participants must agree not to donate blood from the time of vaccination through 3 months after vaccination 7. Participants must be willing to provide verifiable identification and have the means to be contacted and to contact the investigator or the site's staff during the entire clinical trial
Exclusion criteria
1. Participants with moderate or severe liver disease, metastatic solid tumor, and acquired immunodeficiency syndrome (AIDS) are to be excluded. In addition, participants with underlying significant illness or condition(s) or ongoing treatment that, in the opinion of the investigator, could (i) interfere with the conduct of the trial, (ii) pose an unacceptable risk to the participant in this trial, (iii) interfere with the participant's ability to comply with the trial procedures or abide by the procedures 2. Older adults who meet frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the Dalhousie Clinical Frailty Score greater than or equal to \[\>=\]4) 3. Prior receipt of any licensed or investigational RSV or hMPV vaccine within the past 12 months 4. Prior receipt of another investigational medicinal product (IMP; trial drug, biologic, or device) not authorized for use in the United States of America (USA) and European Union within the past 3 months 5. Laboratory-confirmed RSV or hMPV infection within 12 months prior to enrollment 6. Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the trial period 7. History of malignancy within 5 years before screening not in the following categories: (i) 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, (ii) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled 8. Acute illness, with or without fever at the time of planned vaccination 9. History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis or angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex 10. Abnormal function of the immune system resulting from clinical conditions including chronic administration of systemic corticosteroids (oral/intravenous/IM at a daily dose equivalent of greater than (\>) 20 milligram (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months prior to planned vaccination 11. Participants who have received treatment with immunoglobulins or other biologics, such as immunosuppressive therapies expected to modify immune response to vaccination (including monoclonal antibodies \[MAbs\] for chronic underlying conditions) within the past 3 months prior to planned vaccination 12. Trial personnel as an immediate family or household member 13. For licensed vaccines: 1. Receipt of licensed inactivated vaccines (including seasonal influenza vaccine) within 14 days prior to trial vaccine administration on Day 0, or licensed replicating vaccines such as ribonucleic acid (RNA) or live-attenuated virus vaccines within 30 days prior to Day 0 2. Receipt of licensed vaccines is permitted after completion of the Day 28 visit 3. Receipt of any licensed Coronavirus Disease-2019 (COVID-19) vaccines is permitted if dosing regimen completed within 21 days prior to Day 0 or after completion of the Day 28 visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | From Day 0 to Day 6 | Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever. |
| Number of Participants With Unsolicited Adverse Events | From Day 0 to Day 28 | An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant. |
| Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | At Day 28 | Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group. |
| Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | At Day 28 | Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group. |
| Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | From Day 0 (pre-vaccination) up to Day 28 post-vaccination | Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0). |
| Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | From Day 0 (pre-vaccination) up to Day 28 post-vaccination | Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0). |
| Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | From Day 0 (pre-vaccination) up to Day 28 post-vaccination | GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer. |
| Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | From Day 0 (pre-vaccination) up to Day 28 post-vaccination | GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | From Day 0 up to the end of study (up to Day 365) | An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. |
| Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV | From Day 0 up to Day 365 (end of study) | Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group. |
| Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV | From Day 0 up to Day 365 (end of study) | Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group. |
| Number of Participants With Clinically Significant Safety Laboratory Parameters | At Screening, Days 0, 7 and 28 | — |
| Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | At Days 180 and 365 | Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group. |
| Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | At Days 180, and 365 | Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group. |
| Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination | Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0). |
| Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccination | Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0). |
| Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccination | Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0). |
| GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination | GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration. |
| Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | At Days 28, 180, and 365 post-vaccination | The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 10 investigative sites in the United States.
Pre-assignment details
A total 264 participants were enrolled and randomized to receive vaccinations in this study. The study has a Main Trial part and Observation Extension Trial part.
Participants by arm
| Arm | Count |
|---|---|
| Main Trial Part: IVX-A12 150 mcg Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1. | 102 |
| Main Trial Part: IVX-A12 150 mcg With MF59 Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1. | 109 |
| Main Trial Part: Placebo Participants received matching placebo on Day 1. | 53 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Main Trial Part (365 Days) | Death | 1 | 0 | 0 | 0 | 0 |
| Main Trial Part (365 Days) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Main Trial Part (365 Days) | Other | 1 | 2 | 1 | 0 | 0 |
| Main Trial Part (365 Days) | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Observation Extension Part (144 Days) | Sponsor's decision | 0 | 0 | 0 | 35 | 20 |
Baseline characteristics
| Characteristic | Main Trial Part: IVX-A12 150 mcg | Main Trial Part: IVX-A12 150 mcg With MF59 | Main Trial Part: Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 6.05 | 69.3 years STANDARD_DEVIATION 5.83 | 68.8 years STANDARD_DEVIATION 5.79 | 69.2 years STANDARD_DEVIATION 5.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 23 Participants | 7 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 84 Participants | 46 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 14 Participants | 5 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 88 Participants | 94 Participants | 48 Participants | 230 Participants |
| Sex: Female, Male Female | 55 Participants | 65 Participants | 32 Participants | 152 Participants |
| Sex: Female, Male Male | 47 Participants | 44 Participants | 21 Participants | 112 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 103 | 0 / 108 | 0 / 53 | 0 / 35 | 0 / 20 |
| other Total, other adverse events | 75 / 103 | 81 / 108 | 42 / 53 | 3 / 35 | 1 / 20 |
| serious Total, serious adverse events | 5 / 103 | 3 / 108 | 1 / 53 | 1 / 35 | 0 / 20 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 28 | 3.858 fold rise |
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 28 | 4.008 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 28 | 3.465 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 28 | 4.266 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 28 | 0.896 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 28 | 0.987 fold rise |
Primary
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer.
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-A: Day 28 | 5.86 fold rise |
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-B: Day 28 | 3.67 fold rise |
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-A: Day 28 | 3.150 fold rise |
| Main Trial Part: IVX-A12 150 mcg | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-B: Day 28 | 2.426 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-B: Day 28 | 2.746 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-A: Day 28 | 5.07 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-A: Day 28 | 2.486 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-B: Day 28 | 3.11 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-B: Day 28 | 0.936 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-B: Day 28 | 1.08 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | hMPV-A: Day 28 | 0.910 fold rise |
| Main Trial Part: Placebo | Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers | RSV-A: Day 28 | 0.95 fold rise |
Primary
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group.
Time frame: At Day 28
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | RSV | 1549.06 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | hMPV | 1707.15 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | RSV | 1556.06 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | hMPV | 1856.88 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | RSV | 393.03 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab) | hMPV | 444.74 ELISA units per milliliter (EU/mL) |
Primary
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group.
Time frame: At Day 28
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-A | 11980.96 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-B | 7787.22 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-A | 1643.58 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-B | 15503.09 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-B | 17317.65 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-A | 11167.48 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-A | 1416.79 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-B | 6560.64 MN50 titer |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-B | 6370.00 MN50 titer |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-B | 2205.65 MN50 titer |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | hMPV-A | 465.09 MN50 titer |
| Main Trial Part: Placebo | Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb) | RSV-A | 1944.00 MN50 titer |
Primary
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
Time frame: From Day 0 to Day 6
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Local Adverse Reactions | 46 Participants |
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Systemic Adverse Reactions | 34 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Local Adverse Reactions | 68 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Systemic Adverse Reactions | 56 Participants |
| Main Trial Part: Placebo | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Local Adverse Reactions | 5 Participants |
| Main Trial Part: Placebo | Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs | Solicited Systemic Adverse Reactions | 19 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant.
Time frame: From Day 0 to Day 28
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Unsolicited Adverse Events | 33 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Unsolicited Adverse Events | 38 Participants |
| Main Trial Part: Placebo | Number of Participants With Unsolicited Adverse Events | 13 Participants |
Primary
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | RSV: Day 28 | 45.8 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | hMPV: Day 28 | 47.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | RSV: Day 28 | 42.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | hMPV: Day 28 | 52.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | RSV: Day 28 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration | hMPV: Day 28 | 0.0 percentage of participants |
Primary
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 57.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 43.8 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 38.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 25.0 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 35.7 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 55.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 28.6 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 36.7 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 2.1 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 0 percentage of participants |
Secondary
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
Time frame: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 180 | 3.21 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 365 | 1.97 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 180 | 2.02 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 365 | 1.23 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 180 | 1.285 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 365 | 1.094 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 180 | 1.482 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 365 | 1.262 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 180 | 1.728 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 365 | 1.844 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 180 | 2.157 fold rise |
| Main Trial Part: IVX-A12 150 mcg | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 365 | 2.380 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 365 | 2.293 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 180 | 3.18 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 180 | 1.456 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 180 | 1.638 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 365 | 1.68 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 365 | 0.866 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 180 | 2.118 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 180 | 1.88 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 365 | 1.153 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 180 | 1.115 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 365 | 1.20 fold rise |
| Main Trial Part: IVX-A12 150 mcg With MF59 | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 365 | 1.687 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 365 | 0.76 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 180 | 0.736 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 365 | 0.973 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-A: Day 365 | 0.793 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 180 | 0.622 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV-B: Day 365 | 0.681 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 180 | 0.794 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 180 | 1.34 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-A: Day 365 | 0.94 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV Pre-F: Day 180 | 0.774 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV-B: Day 180 | 1.02 fold rise |
| Main Trial Part: Placebo | GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV Pre-F: Day 365 | 1.149 fold rise |
Secondary
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group.
Time frame: At Days 180, and 365
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 730.14 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 781.54 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 925.81 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 1018.26 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 994.03 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 739.32 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 937.01 ELISA units per milliliter (EU/mL) |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 772.83 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 560.77 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 406.42 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 386.81 ELISA units per milliliter (EU/mL) |
| Main Trial Part: Placebo | Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 313.74 ELISA units per milliliter (EU/mL) |
Secondary
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group.
Time frame: At Days 180 and 365
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 180 | 6864.00 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 365 | 4142.06 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 180 | 4536.59 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 365 | 2690.13 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 180 | 667.67 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 365 | 589.68 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 180 | 9709.73 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 365 | 8519.18 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 180 | 4152.76 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 180 | 9482.90 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 365 | 2640.17 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 180 | 690.94 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 365 | 535.25 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 180 | 7145.43 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 365 | 3793.79 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 365 | 7699.03 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 180 | 2205.81 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 365 | 1933.12 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-A: Day 180 | 2741.63 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | RSV-B: Day 365 | 1640.56 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 180 | 4243.59 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 365 | 421.28 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-A: Day 180 | 383.31 MN50 titer |
| Main Trial Part: Placebo | Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb | hMPV-B: Day 365 | 4743.25 MN50 titer |
Secondary
Number of Participants With Clinically Significant Safety Laboratory Parameters
Time frame: At Screening, Days 0, 7 and 28
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Clinically Significant Safety Laboratory Parameters | 0 participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Clinically Significant Safety Laboratory Parameters | 0 participants |
| Main Trial Part: Placebo | Number of Participants With Clinically Significant Safety Laboratory Parameters | 0 participants |
Secondary
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Time frame: From Day 0 up to Day 365 (end of study)
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV | 4 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV | 2 Participants |
| Main Trial Part: Placebo | Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV | 0 Participants |
Secondary
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
Time frame: From Day 0 up to Day 365 (end of study)
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV | 14 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV | 11 Participants |
| Main Trial Part: Placebo | Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV | 4 Participants |
Secondary
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Time frame: From Day 0 up to the end of study (up to Day 365)
Population: The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | MAAEs | 54 Participants |
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | SAEs | 5 Participants |
| Main Trial Part: IVX-A12 150 mcg | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | AE Leading to Study Discontinuation | 1 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | MAAEs | 60 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | SAEs | 3 Participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | AE Leading to Study Discontinuation | 0 Participants |
| Main Trial Part: Placebo | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | SAEs | 1 Participants |
| Main Trial Part: Placebo | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | AE Leading to Study Discontinuation | 0 Participants |
| Main Trial Part: Placebo | Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal | MAAEs | 21 Participants |
Secondary
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 12.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 8.0 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 21.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 27.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 20.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 12.0 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 19.6 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 10.2 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 365 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 365 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | hMPV: Day 180 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations | RSV: Day 180 | 0.0 percentage of participants |
Secondary
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 35.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 18.2 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 23.7 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 6.8 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 7.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 6.8 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 12.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 9.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 18.7 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 14.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 9.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 6.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 4.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 35.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 21.6 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 3.4 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 4.4 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 2.3 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 6.7 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 2.3 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 2.3 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 0.0 percentage of participants |
Secondary
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0).
Time frame: From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 39.6 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 16.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 8.0 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 21.9 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 7.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 2.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 13.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 2.2 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 1.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 11.5 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 4.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 1.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 2.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 38.8 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 15.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 0 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 20.7 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 3.4 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 4.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 9.1 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 2.2 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 4.4 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 16.3 percentage of participants |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 19.4 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 28 | 2.1 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 180 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 28 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-B: Day 365 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 28 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 180 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 180 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 28 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 180 | 2.2 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-A: Day 365 | 0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | RSV-A: Day 365 | 0.0 percentage of participants |
| Main Trial Part: Placebo | Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers | hMPV-B: Day 365 | 0 percentage of participants |
Secondary
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
Time frame: At Days 28, 180, and 365 post-vaccination
Population: The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 180 | 653.30 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 365 | 2606.69 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 0 | 1779.18 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 28 | 1544.51 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 0 | 415.73 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 365 | 3793.15 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 0 | 359.94 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 28 | 3.145 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 365 | 967.80 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 365 | 518.85 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 180 | 636.90 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 28 | 1857.88 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 0 | 1965.30 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 180 | 959.30 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 0 | 410.74 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 28 | 6945.86 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 180 | 6393.44 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 365 | 691.49 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 180 | 4226.30 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 28 | 12010.69 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 28 | 1757.83 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 0 | 2068.22 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 28 | 10806.21 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 180 | 6244.78 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 365 | 3630.01 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 0 | 2046.80 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 28 | 6491.77 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 180 | 3427.10 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 365 | 2191.31 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 0 | 538.90 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 28 | 2.223 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 180 | 716.65 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 365 | 514.09 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 0 | 432.69 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 28 | 1574.69 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 180 | 774.70 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 365 | 879.79 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 0 | 524.42 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 180 | 920.64 MN50 titer |
| Main Trial Part: IVX-A12 150 mcg With MF59 | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 365 | 989.21 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 28 | 1943.00 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 28 | 439.00 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 180 | 2192.40 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 365 | 621.84 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 180 | 308.60 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 28 | 1757.20 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 180 | 383.20 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 365 | 483.45 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 0 | 1722.20 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 0 | 1764.10 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 0 | 531.20 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 365 | 1769.58 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 180 | 320.50 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 28 | 0.999 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-A: Day 180 | 2601.00 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 365 | 313.65 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV-A: Day 0 | 360.50 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | hMPV Pre F: Day 28 | 444.00 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV Pre F: Day 0 | 489.60 MN50 titer |
| Main Trial Part: Placebo | Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations | RSV-B: Day 365 | 1416.93 MN50 titer |