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Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE IN ADULTS ≥65 YEARS OF AGE

NCT05301322•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Detailed Description

This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind study will be conducted in Australia and/or another southern hemisphere country. Healthy adults ≥65 years of age will be randomized 1:1 to either the coadministration group (RSVpreF + SIIV)/placebo or the sequential-administration group (placebo + SIIV)/RSVpreF. This study design intends to use a single lot of NIP SIIV that is specifically indicated for use in adults ≥65 years of age. There are 3 scheduled study visits each 1 month apart. To assess immunogenicity, 30 mL blood will be collected prior to vaccination at Visit 1 and Visit 2, and at Visit 3. Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or placebo injection site (left deltoid) and systemic events (fever, headache, fatigue, nausea, vomiting, diarrhea, muscle pain, and joint pain) occurring within 7 days after each vaccination visit (Visit 1 and Visit 2) will be prompted for and collected daily by the participant in an e-diary device or smartphone app. SIIV injection site reactions will not be routinely collected in the e-diary. AEs and SAEs will be collected from the signing of informed consent through Visit 3.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male and female participants ≥65 years of age at the time of consent.
•2. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after each study vaccination.
•3. Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for inclusion in the study.
•4. Capable of giving signed informed consent

Exclusion Criteria

•1. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.
•2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
•3. Allergy to egg proteins (egg or egg products) or chicken proteins.
•4. History of Guillain-Barré syndrome.
•5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
•6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
•7. Other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
•8. Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt throughout the study of nonstudy RSV vaccine.
•9. Previous vaccination with any influenza vaccine within 6 months before study intervention administration, or planned receipt of any nonstudy licensed or investigational influenza vaccine during study participation.
•10. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
+5 more criteria

Locations (33)

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, Australia

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

Emeritus Research

Botany, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Northside Health

Coffs Harbour, New South Wales, Australia

Holdsworth House Medical Practice

Darlinghurst, New South Wales, Australia

Paratus Clinical Research Central Coast

Kanwal, New South Wales, Australia

The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Key Dates

Start Date

April 13, 2022

Primary Completion Date

October 12, 2022

Completion Date

October 12, 2022

Last Updated

October 27, 2023

Enrollment

1,471

ACTUAL participants

Conditions

Respiratory Syncytial Virus

Interventions

RSVpreF Vaccine

BIOLOGICAL

Placebo

OTHER

Seasonal Inactivated Influenza Vaccine

BIOLOGICAL

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

COVID-19 Impact on RSV Emergency Presentations

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

Antibiotic Therapy in Viral Airway Infections

Assessing Antiviral Treatments in Early Symptomatic RSV