Respiratory Syncytial Virus (RSV)Phase 3NCT02608502
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
A Phase 3 study testing RSV-F Vaccine in people with Respiratory Syncytial Virus (RSV), run by Novavax at 60 sites in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSV-F Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,850 participants
- Where
- 60 sitesUnited States
- Study dates
- Nov 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that 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 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.
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements; including access to transportation for study visits.
- Access to inbound and outbound telephone communication with caregivers and study staff.
Who cannot join
- Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
- Receipt of any vaccine other than an IIV in the 4 weeks preceding the study vaccination or a pneumococcal vaccine in the 2 weeks preceding the study vaccination; or any RSV vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- 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.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Show all 10Show fewer
- 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).
- Known uncontrolled disorder 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.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- 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).
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Research Site US005
Anaheim, California, 92801
Research Site US047
Austin, Texas, 78705
Research Site US066
Binghamton, New York, 13901
Research Site US062
Birmingham, Alabama, 35216
Research Site US012
Boise, Idaho, 83642
Research Site US074
Bristol, Tennessee, 37620
Research Site US078
Cary, North Carolina, 27518
Research Site US070
Charleston, South Carolina, 29407
Research Site US069
Chicago, Illinois, 60654
Research Site US081
Cincinnati, Ohio, 45219
Research Site US085
Cincinnati, Ohio, 45227
Research Site US030
Cleveland, Ohio, 44122
Research Site US050
Dakota Dunes, South Dakota, 57049
Research Site US010
Dallas, Texas, 75234
Research Site US020
Durham, North Carolina, 27710
Research Site US072
Edina, Minnesota, 55435
Research Site US017
Endwell, New York, 13760
Research Site US083
Fort Worth, Texas, 76104
Research Site US060
Fort Worth, Texas, 76135
Research Site US019
Houston, Texas, 77030
Research Site US051
Kansas City, Missouri, 64114
Research Site US077
Knoxville, Tennessee, 37920
Research Site US057
Las Vegas, Nevada, 89119
Research Site US003
Lenexa, Kansas, 66219
Research Site US080
Lexington, Kentucky, 40509
Research Site US024
Marshfield, Wisconsin, 54449
Research Site US046
Mesa, Arizona, 85206
Research Site US068
Metairie, Louisiana, 70002
Research Site US039
Metairie, Louisiana, 70006
Research Site US055
Methuen, Massachusetts, 01844
Research Site US061
Mobile, Alabama, 36608
Research Site US056
Mt. Pleasant, South Carolina, 29464
Research Site US079
Mt. Pleasant, South Carolina, 29464
Research Site US029
Nashville, Tennessee, 37203
Research Site US059
Newington, New Hampshire, 03801
Research Site US052
Newton, Kansas, 67114
Research Site US025
Norfolk, Nebraska, 68701
Research Site US067
Norfolk, Virginia, 23507
Research Site US053
Oklahoma City, Oklahoma, 73112
Research Site US018
Omaha, Nebraska, 68134
Research Site US065
Peoria, Illinois, 61614
Research Site US054
Phoenix, Arizona, 85050
Research Site US028
Redding, California, 96001
Research Site US049
Rochester, New York, 14609
Research Site US082
Salt Lake City, Utah, 84109
Research Site US075
Salt Lake City, Utah, 84121
Research Site US008
Salt Lake City, Utah, 84124
Research Site US084
San Angelo, Texas, 76904
Research Site US064
San Diego, California, 92117
Research Site US045
Savannah, Georgia, 31406
Research Site US026
Seattle, Washington, 98101
Research Site US076
St Louis, Missouri, 63141
Research Site US013
Stockbridge, Georgia, 30281
Research Site US048
Tempe, Arizona, 85283
Research Site US073
Tomball, Texas, 77375
Research Site US044
Warwick, Rhode Island, 02886
Research Site US027
West Jordan, Utah, 84088
Research Site US058
Wichita, Kansas, 67207
Research Site US071
Wilmington, North Carolina, 28401
Research Site US063
Winston-Salem, North Carolina, 27103
About this study
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSV-F Vaccine, Phosphate Buffer Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV-F VaccineBiological
Phosphate Buffer PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | RSV-F Vaccine (0.5mL Injection) Receives: Biological: RSV-F Vaccine |
| Treatment Group B | Placebo comparator | Phosphate Buffer Placebo (0.5mL Injection) Receives: Biological: Phosphate Buffer Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers and percentages of subjects with moderate-severe RSV-LRTD
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Measured: Day 0 to Day 182
Numbers and percentages of subjects with solicited local and systemic AEs
Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
Measured: Day 0 to Day 364
Secondary outcomes (6)
Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)
Defined by the presence of at least one (1) of: rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath; plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Measured: Day 0 to Day 182
RSV F protein antibody expressed as ELISA Units (EU).
Summarized by:
- Geometric Mean Concentrations as EU (GMEU)
- Geometric Mean Ratio (GMR)
- Seroresponse Rate (SRR)
Measured: Day 0 to Day 364
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Summarized by:
- Geometric Mean Concentrations as EU (GMEU)
- Geometric Mean Fold Rise (GMFR)
Measured: Day 0 to Day 364
Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain
Summarized by:
- Geometric Mean Titer (GMT)
- Geometric Mean Ratio (GMR)
Measured: Day 0 to Day 28
Number and percentage of subjects with RSV-ARD and/or RSV-LRTD
Summarized by treatment group and by age strata and in strata defined by comorbidities and type of community housing.
Measured: Day 0 to Day 364
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608502
- Sponsor's protocol ID
- RSV-E-301
- Status last verified
- Jul 2022
- First submitted
- 10 Nov 2015
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
- ClinicalTrials.gov ID
- NCT02608502
- Acronym / sponsor ID
- RSV-E-301
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,850 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Biological: RSV-F VaccineRSV-F Vaccine (0.5mL Injection) |
| Treatment Group B | Placebo comparator | Biological: Phosphate Buffer PlaceboPhosphate Buffer Placebo (0.5mL Injection) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that 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:
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements; including access to transportation for study visits.
- Access to inbound and outbound telephone communication with caregivers and study staff.
Key exclusion criteria (10 listed)
- Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
- Receipt of any vaccine other than an IIV in the 4 weeks preceding the study vaccination or a pneumococcal vaccine in the 2 weeks preceding the study vaccination; or any RSV vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV-F Vaccine | Biological | Treatment Group A |
| Phosphate Buffer Placebo | Biological | Treatment Group B |
Primary outcome
Numbers and percentages of subjects with moderate-severe RSV-LRTD
Time frame: Day 0 to Day 182
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Numbers and percentages of subjects with solicited local and systemic AEs
Time frame: Day 0 to Day 364
Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
6 secondary outcomes
Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)
Time frame: Day 0 to Day 182
RSV F protein antibody expressed as ELISA Units (EU).
Time frame: Day 0 to Day 364
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Time frame: Day 0 to Day 364
Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain
Time frame: Day 0 to Day 28
Number and percentage of subjects with RSV-ARD and/or RSV-LRTD
Time frame: Day 0 to Day 364
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article.
Time frame: Day 0 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Novavax WebpageLink provided by the sponsor.
Related trials for Respiratory Syncytial Virus (RSV)
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
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
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Novavax, Inc.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSV-F Vaccine in people with Respiratory Syncytial Virus (RSV), run by Novavax at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and percentages of subjects with moderate-severe RSV-LRTD (time frame: Day 0 to Day 182). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.