At a glance
ClinicalIndex Comparison Record- ✓Age ≥60 years at enrollment (Substudy A)
- ✓Age ≥50 years at enrollment (Substudy B)
- ✓Healthy status determined by medical history, physical examination, and investigator judgment
- ✓Receipt of licensed influenza vaccine >120 days before study (Substudy A)
- ✕Confirmed RSV or influenza infection within 120 days of study start
- ✕History of severe adverse reaction to any vaccine or component of study intervention
- ✕Bleeding diathesis or condition with prolonged bleeding contraindicating IM injection
- ✕Serious chronic disorder including metastatic malignancy, end-stage renal disease, or clinically unstable cardiac disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Combination Vaccine Candidates in Older Adults
In Brief
A Phase 1 clinical trial evaluating RSVpreF+qIRV, qIRV, and 4 other interventions for Healthy. Completed, enrolled 508 participants across 1 site.
Detailed Summary
Substudy A: The study aims to learn about the safety and effects of two new vaccines for RSV (RSVpreF) and influenza (modRNA qIRV) when given as a single shot compared to when given separately. RSV and influenza lead to infections, mainly in the fall and winter. These vaccines are being developed to help prevent respiratory syncytial virus (RSV) and influenza (Flu) disease. This study is seeking participants who: * are 60 years or older * are healthy or have well-controlled chronic conditions * have not had a flu shot in the last 120 days * and agree to be present for all study visits, procedures, and blood draws. The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV combo shot, after which participants will receive the placebo (a shot which has no medicine). Group 2 will receive shots for qIRV first and then RSVpreF 1 month apart. The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe and produce a similar immune response. Participants will be involved in this study for 2 months. During this time, participants will have 3 visits at the study clinic. Substudy B will investigate 2 formulations of RSVpreF + qIRV of different volumes and osmolaities (concentrations). These formulations will be examined for safety, tolerability, and immunogenicity, with the goal of selecting a formulation for further study. This study is seeking participants who: * are 50 years or older * are healthy or have well-controlled chronic conditions * have not had a flu shot in the last 180 days * and agree to be present for all study visits, procedures, and blood draws. The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV in a 1.0-mL formulation while Group 2 will receive RSVpreF plus qIRV in a 0.5-mL formulation. The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe, well tolerated and produce a similar immune response. Participants will be involved in this study for 1 month. During this time, participants will have 2 visits at the study clinic.
Study Details
Timeline
Interventions
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B
0.9% saline for injection
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains)