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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
143
IVX-A12 IM injection.
Licensed RSV Vaccine (AREXVY) IM injection.
Icosavax Investigational Site US022
Anaheim, California, United States
Icosavax Investigational Site US021
Rolling Hills Estates, California, United States
Icosavax Investigational Site US002
Hollywood, Florida, United States
Icosavax Investigational Site US011
Lenexa, Kansas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Day 1 through Day 8
Number of Participants With Unsolicited Adverse Events (AEs)
The unsolicited AEs were any AE other than predefined solicited AEs.
Time frame: 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)
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.
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Icosavax Investigational Site US016
North Charleston, South Carolina, United States
Time frame: Day 1 through Day 29