Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
330 participants
INTERVENTIONAL
2012-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
Low dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
Low dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Group B
Low dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
Low dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Placebo
0.5mL IM Injection
Group C
Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
Low dose RSV-F Vaccine without Adjuvant
0.5ml IM Injection
Group D
Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
Low dose RSV-F Vaccine without Adjuvant
0.5ml IM Injection
Placebo
0.5mL IM Injection
Group E
High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28)
High dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Group F
High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28)
High dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Placebo
0.5mL IM Injection
Group G
High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28)
High dose RSV-F Vaccine without Adjuvant
0.5mL IM Injection
Group H
High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28)
High dose RSV-F Vaccine without Adjuvant
0.5mL IM Injection
Placebo
0.5mL IM Injection
Group J
Low dose RSV-F Vaccine with Adjuvant \[Bedside Mixing\] (Day 0 \& Day 28)
Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
0.5mL IM Injection
Group K
Placebo (Day 0 and Day 28)
Placebo
0.5mL IM Injection
Interventions
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Low dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
Low dose RSV-F Vaccine without Adjuvant
0.5ml IM Injection
High dose RSV-F Vaccine with Adjuvant
0.5mL IM Injection
High dose RSV-F Vaccine without Adjuvant
0.5mL IM Injection
Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
0.5mL IM Injection
Placebo
0.5mL IM Injection
Eligibility Criteria
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Inclusion Criteria
* Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives.
* Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible.
* Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below.
* Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
* Willing and able to give informed consent prior to study enrollment.
* Able to comply with study requirements.
* Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.
Exclusion Criteria
* History of a serious reaction to any prior vaccination.
* Received any vaccine in the 4 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.
* 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 disturbance of coagulation.
* Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
* 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 or psychiatric conditions deemed likely to impair the quality of safety reporting).
18 Years
35 Years
FEMALE
Yes
Sponsors
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PATH
OTHER
Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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D. Nigel Thomas, Ph.D.
Role: STUDY_DIRECTOR
Novavax, Inc.
Locations
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Anaheim Clinical Trials
Anaheim, California, United States
Accelovance Rockville
Rockville, Maryland, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Countries
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References
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Glenn GM, Fries LF, Thomas DN, Smith G, Kpamegan E, Lu H, Flyer D, Jani D, Hickman SP, Piedra PA. A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age. J Infect Dis. 2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.
Related Links
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Novavax Homepage
Other Identifiers
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NVX757.201
Identifier Type: -
Identifier Source: org_study_id
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