NCT05788237

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Combination Vaccine Candidates in Older Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Substudy A: This study is designed to evaluate the safety, tolerability, and immunogenicity of respiratory combination vaccine candidates. This initial study will be conducted as a Phase 1b, parallel-group, randomized, placebo-controlled, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza when administered as a combined vaccine and when administered alone. Healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) followed by placebo; or Group 2: sequential administration of qIRV followed by RSVpreF administered 1 month apart. Substudy B will be conducted as a Phase 1b, parallel-group, randomized, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza administered as a combined vaccine in a 1.0-mL formulation and when administered in a 0.5-mL formulation. Healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Approximately 100 participants will be randomized within the 50- through 64-year-old group, and 100 participants ≥65 years of age will be randomized.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	RSVpreF+qIRV	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)
BIOLOGICAL	qIRV	Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
BIOLOGICAL	RSVpreF	RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B
DRUG	Placebo	0.9% saline for injection
BIOLOGICAL	RSVpreF + qIRV 1.0 mL formulation	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
BIOLOGICAL	RSVpreF + qIRV 0.5 mL formulation	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)

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2023-03-28
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated drug study