Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03026348
Other study ID # RSV-E-205
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2017
Est. completion date May 18, 2018

Study information

Verified date December 2021
Source Novavax
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
RSV F Vaccine with Aluminum Phosphate Adjuvant

RSV F Vaccine

Matrix-M1 Adjuvant

Other:
Phosphate Buffer


Locations

Country Name City State
Australia Research Site AU002 Adelaide South Australia
Australia Research Site AU005 Herston Queensland
Australia Resarch Site AU001 Nedlands Western Australia
Australia Research Site AU006 Prahran Victoria
Australia Research Site AU004 Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Novavax

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neutralizing antibody titers to at least one RSV/A strain Day 0, 21, 28
Primary Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0. Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
Secondary Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein. Day 0, 21, 28, 56, 119, 385
Secondary Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Day 0, 21, 28, 56, 119, 385
Secondary Counts of IFN-? spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides. Day 0, 7, 28
Secondary Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-?, or TNF-a production (alone or any combination thereof) following in vitro stimulation with RSV F peptides. Day 0, 7, 28
See also
  Status Clinical Trial Phase
Completed NCT02561871 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers Phase 1
Completed NCT04086472 - Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005) Phase 2
Terminated NCT02935673 - Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus Phase 2
Completed NCT04068792 - A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease Phase 2
Completed NCT03303625 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age Phase 1/Phase 2
Terminated NCT03333317 - A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus Phase 2
Recruiting NCT06077968 - A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Infection.
Active, not recruiting NCT05966090 - A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults Phase 3
Completed NCT04908683 - A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older Phase 3
Completed NCT00585481 - Incidence of Severe Respiratory Syncytial Virus Infections in Preterm Brazilian Children N/A
Completed NCT05712460 - A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants Phase 1
Completed NCT01249625 - The Respiratory Protection Effectiveness Clinical Trial N/A
Completed NCT00263900 - TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit N/A
Terminated NCT03982199 - A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older Phase 2