Loading clinical trials...

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS

NCT03572062•Pfizer

View on ClinicalTrials.gov

Summary

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose. In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.

Detailed Description

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant. If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination. 62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.

Eligibility

Age

65 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
•2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
•3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
•4. Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).
•5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

Exclusion Criteria

•1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
•2. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
•3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
•4. Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine.
•5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2).
•6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s), including natural rubber latex. In addition, a history of severe allergic reaction (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg or egg products) or chicken proteins.
•7. Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
•8. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration.Inhaled/nebulized, intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are permitted.
•9. Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome,multiple sclerosis, Sjögren syndrome, idiopathic thrombocytopenic purpura, autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
•10. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
+4 more criteria

Locations (16)

Qps Mra, Llc

South Miami, Florida, United States

Optimal Research, LLC

Peoria, Illinois, United States

Synexus Clinical Research US

Fremont, Nebraska, United States

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Australian Clinical Research Network

Maroubra, New South Wales, Australia

AIM Centre (Hunter Diabetes Centre)

Merewether, New South Wales, Australia

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Westmead Hospital (Infectious Diseases and Microbiology)

Westmead, New South Wales, Australia

Data Health Australia Pty Limited (Trading as AusTrials)

Taringa, Queensland, Australia

Eastern Health

Box Hill, Victoria, Australia

Key Dates

Start Date

June 5, 2018

Primary Completion Date

June 23, 2020

Completion Date

August 19, 2020

Last Updated

August 26, 2021

Enrollment

317

ACTUAL participants

Conditions

Respiratory Tract Infection

Interventions

Formulation A

BIOLOGICAL

Formulation B

BIOLOGICAL

Formulation C

BIOLOGICAL

Placebo

BIOLOGICAL

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

View study

RECRUITING

Respiratory Infections in Young Children

NCT07249996

Respiratory Tract Infections (RTI)Lower Respiratory Tract Infection (LRTI)+2 more

View study

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: August 26, 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

Inclusion Criteria

Exclusion Criteria

The Fever Clinic Acute Respiratory Cohort

Respiratory Infections in Young Children

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Antibiotic Therapy in Viral Airway Infections

How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.

To Evaluate Mucosal and Systematic Immune Response to Acute Respiratory Tract Infections of South African Children