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The primary purpose of this study is to assess the immunogenicity and safety of IVX-A12 in adults 60 years of age and older.
This is a randomized, modified double-blind, active controlled study to characterize the immunogenicity and safety of IVX-A12.
Approximately 140 participants will be randomized in a 1:1 ratio to receive IVX-A12 (approximately 70) or licensed respiratory syncytial virus (RSV) vaccine (AREXVY) (approximately 70).
The study is planned to be conducted at approximately 5 sites in the United States. The duration of each participant's involvement in the study will be approximately 6 months following administration of study vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVX-A12 Vaccine | Experimental | Participants will receive a single dose of IVX-A12, 300 micrograms (mcg), intramuscular (IM) injection on Day 1. |
|
| Licensed RSV Vaccine | Active Comparator | Participants will receive a single dose of licensed RSV vaccine (AREXVY) IM injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVX-A12 | Biological | IVX-A12 IM injection. |
| |
| Licensed RSV Vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Model-adjusted Geometric Mean Concentration (GMC) for RSV/A Neutralizing Antibodies (NAb) | Model-adjusted GMCs and 95% CIs were derived using an ANCOVA model for log2 nAb responses at Day 29 with independent variables of study intervention, log2 baseline response, and age group. Measured values were calculated as the anti-logarithm transformation of the least square means and 95% CIs from the model. | At Day 29 |
| Geometric Mean Fold Rise (GMFR) in RSV/A NAb Concentrations | The GMFR was calculated as the anti-logarithm of Σ(log2 transformed (post-baseline response/baseline response)/n), where n is the number of participants with non-missing response information at baseline and at the post-baseline timepoint. | From baseline up to Day 29 |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Immediate AEs were defined as having an onset time within 30 minutes after study vaccination. | Within the 30 minutes after vaccination on Day 1 |
| Number of Participants With Injection Site and Systemic Solicited Adverse Reactions (ARs) | The injection site solicited ARs included predefined injection site pain, injection site erythema/redness, and injection site swelling. The systemic solicited ARs included predefined fever, chills, headache, myalgia (muscle aches and pains), and fatigue (physical or mental tiredness). | Day 1 through Day 8 |
| Number of Participants With Unsolicited Adverse Events (AEs) | The unsolicited AEs were any AE other than predefined solicited AEs. | Day 1 through Day 29 |
| Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icosavax Investigational Site US022 | Anaheim | California | 92801 | United States | ||
| Icosavax Investigational Site US021 |
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A total 143 participants were enrolled and randomized to receive vaccinations in this study.
Participants were recruited at 5 investigative sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVX-A12 | Participants received a single dose of 300 micrograms (mcg) IVX-A12, intramuscular (IM) injection on Day 1. |
| FG001 | AREXVY | Participants received a single dose of 120 mcg AREXVY, IM injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety analysis set (SAF) included all randomized participants who received one dose of study intervention, irrespective of their protocol adherence and continued participation in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | IVX-A12 | Participants received a single dose of 300 mcg IVX-A12, IM injection on Day 1. |
| BG001 | AREXVY | Participants received a single dose of 120 mcg AREXVY, IM injection on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Model-adjusted Geometric Mean Concentration (GMC) for RSV/A Neutralizing Antibodies (NAb) | Model-adjusted GMCs and 95% CIs were derived using an ANCOVA model for log2 nAb responses at Day 29 with independent variables of study intervention, log2 baseline response, and age group. Measured values were calculated as the anti-logarithm transformation of the least square means and 95% CIs from the model. | Immunogenicity analysis set (IAS) included all participants in the SAF who had no eligibility-related protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | internation unit per milliliter (IU/mL) | At Day 29 |
|
Day 1 through Day 181
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVX-A12 | Participants received a single dose of 300 mcg IVX-A12, IM injection on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2024 | Jul 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2024 | Jul 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729227 | arexvy |
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| Biological |
Licensed RSV Vaccine (AREXVY) IM injection. |
|
|
A SAE defined as an AE that occurred during any phase of study and met one or more of following criteria: resulted in death; was immediately life-threatening; required in-patient hospitalization or led to prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; or was considered an important medical event that might have jeopardized the participant or required medical intervention to prevent one of aforementioned outcomes. MAAEs defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. An AESI was an event of scientific and medical interest, specific to further understanding of safety profile of investigational vaccine and required close monitoring and rapid communication by Investigators to the Sponsor. |
| Day 1 through Day 29 |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Icosavax Investigational Site US002 | Hollywood | Florida | 33024 | United States |
| Icosavax Investigational Site US011 | Lenexa | Kansas | 66219 | United States |
| Icosavax Investigational Site US016 | North Charleston | South Carolina | 29405 | United States |
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | AREXVY | Participants received a single dose of 120 mcg AREXVY, IM injection on Day 1. |
|
|
| Primary | Geometric Mean Fold Rise (GMFR) in RSV/A NAb Concentrations | The GMFR was calculated as the anti-logarithm of Σ(log2 transformed (post-baseline response/baseline response)/n), where n is the number of participants with non-missing response information at baseline and at the post-baseline timepoint. | IAS included all participants in the SAF who had no eligibility-related protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | From baseline up to Day 29 |
|
|
|
| Primary | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Immediate AEs were defined as having an onset time within 30 minutes after study vaccination. | The SAF included all randomized participants who received one dose of study intervention, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Within the 30 minutes after vaccination on Day 1 |
|
|
|
| Primary | Number of Participants With Injection Site and Systemic Solicited Adverse Reactions (ARs) | The injection site solicited ARs included predefined injection site pain, injection site erythema/redness, and injection site swelling. The systemic solicited ARs included predefined fever, chills, headache, myalgia (muscle aches and pains), and fatigue (physical or mental tiredness). | The SAF included all randomized participants who received one dose of study intervention, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Day 1 through Day 8 |
|
|
|
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) | The unsolicited AEs were any AE other than predefined solicited AEs. | The SAF included all randomized participants who received one dose of study intervention, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Day 1 through Day 29 |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs) | A SAE defined as an AE that occurred during any phase of study and met one or more of following criteria: resulted in death; was immediately life-threatening; required in-patient hospitalization or led to prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; or was considered an important medical event that might have jeopardized the participant or required medical intervention to prevent one of aforementioned outcomes. MAAEs defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. An AESI was an event of scientific and medical interest, specific to further understanding of safety profile of investigational vaccine and required close monitoring and rapid communication by Investigators to the Sponsor. | The SAF included all randomized participants who received one dose of study intervention, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Day 1 through Day 29 |
|
|
|
| 1 |
| 71 |
| 2 |
| 71 |
| 6 |
| 71 |
| EG001 | AREXVY | Participants received a single dose of 120 mcg AREXVY, IM injection on Day 1. | 0 | 72 | 1 | 72 | 15 | 72 |
| Cardiac disorder | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
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| AESIs |
|