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Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

NCT03026348•Novavax

View on ClinicalTrials.gov

Summary

This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males and females 60 through 80 years of age who are ambulatory and live in the community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
•* Absence of changes in medical therapy within one month due to treatment failure or toxicity (dose adjustments of ongoing therapies for optimal effect, or replacements within a class of drugs due to convenience or cost, will be deemed acceptable),
•* Absence of medical events qualifying as SAEs within one month of the planned vaccination on Day 0, and
•* Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol unlikely.
•2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. To complete the consent process, all qualifying subjects will correctly answer at least 4 out of 5 questions of the informed consent form (ICF) comprehension assessment in no more than 2 attempts.
•3. Able to comply with study requirements. As the protocol procedures involve telephone contacts for safety ascertainment, eligible subjects must have a reliable access to a telephone.

Exclusion Criteria

•1. Received any prior RSV vaccine.
•2. Participation in research involving any additional investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
•3. History of a serious reaction to any prior vaccination or a history of Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
•4. Receipt of inactivated influenza vaccine within 14 days prior to the Day 0 dose of test article or any other vaccine within the 4 weeks prior to the Day 0 dose of test article.
•5. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
•6. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
•7. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
•8. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C on the planned day of vaccine administration).
•9. Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
•10. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
+1 more criteria

Locations (5)

Research Site AU004

Sydney, New South Wales, Australia

Research Site AU005

Herston, Queensland, Australia

Research Site AU002

Adelaide, South Australia, Australia

Research Site AU006

Prahran, Victoria, Australia

Resarch Site AU001

Nedlands, Western Australia, Australia

Key Dates

Start Date

January 1, 2017

Primary Completion Date

April 1, 2017

Completion Date

May 18, 2018

Last Updated

December 6, 2021

Enrollment

300

ACTUAL participants

Conditions

Respiratory Syncytial Viruses

Interventions

RSV F Vaccine with Aluminum Phosphate Adjuvant

BIOLOGICAL

RSV F Vaccine

BIOLOGICAL

Matrix-M1 Adjuvant

BIOLOGICAL

Phosphate Buffer

OTHER

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NCT05966090

Respiratory Syncytial VirusesRespiratory Syncytial Virus Infections

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COMPLETEDPHASE2

A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

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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: December 6, 2021Data 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.

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Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

Inclusion Criteria

Exclusion Criteria

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

The Respiratory Protection Effectiveness Clinical Trial