Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593071
Other study ID # RSV-E-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2015
Est. completion date November 2016

Study information

Verified date May 2022
Source Novavax
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.


Recruitment information / eligibility

Status Completed
Enrollment 1330
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Males and females =60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide 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, - Absence of medical events qualifying as SAEs within two months, and - Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely. 2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. 3. Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201. 4. Access to inbound and outbound communication by telephone with caregivers and study staff. Exclusion Criteria: 1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201. 2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator. 3. Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201. 4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination. 5. 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 =10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 7. 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). 8. 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. 9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. 10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).

Study Design


Related Conditions & MeSH terms

  • Respiratory Syncytial Virus (RSV)

Intervention

Biological:
RSV-F Vaccine

Phosphate Buffer Placebo


Locations

Country Name City State
United States Rapid Medical Research Cleveland Ohio
United States Research Across America Dallas Texas
United States Johnson County Clin-Trials Lenexa Kansas
United States Clinical Research Associates Nashville Tennessee
United States Nothern California Clinical Research Redding California
United States Clinical Trials of Texas San Antonio Texas
United States Group Health Research Institute Seattle Washington
United States Clinical Research Atlanta Stockbridge Georgia
United States Marshfield Clinical Research Foundation Wausau Wisconsin
United States Advanced Clinical Research West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups. Day 0 to Day 182
Other Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR. Day 0 to Day 182
Primary Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include:
Geometric mean concentration as EU (GMEU)
Geometric mean ratio (GMR)
Seroresponse rate (SRR)
Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 364
Primary Numbers and percentages of subjects with solicited local and systemic AEs Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing Day 0 to Day 364
Secondary Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA Summarized by:
Geometric mean concentrations (GMC)
Geometric mean ratio (GMR)
Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 182
Secondary Neutralizing antibody titer to at least one RSV/A and one RSV/B strain. Summarized by:
Geometric mean titer (GMT)
Geometric mean ratio (GMR)
Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 182
See also
  Status Clinical Trial Phase
Completed NCT02282982 - Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis N/A
Completed NCT02266628 - Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults Phase 2
Completed NCT01704365 - RSV-F Vaccine Dose Ranging Study in Young Women Phase 2
Completed NCT01709019 - RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly Phase 1
Recruiting NCT06185647 - Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
Recruiting NCT04925310 - Infection With Respiratory Syncytial Virus in Infants
Completed NCT02968173 - A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus Phase 3
Active, not recruiting NCT06077149 - Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) Phase 4
Completed NCT02608502 - A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults Phase 3
Recruiting NCT05047549 - Community-based RSV Surveillance in Infant Mortality: Minimally Invasive Tissue Sampling Study in Karachi, Pakistan
Terminated NCT04225897 - A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. Phase 2
Recruiting NCT06216093 - Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years Phase 1
Not yet recruiting NCT06392451 - LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia N/A
Completed NCT04927793 - Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects Phase 1
Active, not recruiting NCT05443607 - Transplacental Transmission of RSV (TTRSV)
Recruiting NCT04896853 - Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans® Phase 1
Completed NCT03916185 - Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age Phase 1/Phase 2
Completed NCT05842967 - A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease Phase 3
Recruiting NCT04909021 - Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months Phase 1
Completed NCT05900154 - A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age Phase 1