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
720 participants
INTERVENTIONAL
2013-10-31
2014-04-30
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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Low dose RSV F Vaccine with Dose 1 of Aluminum Adjuvant
Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
Low dose RSV F Antigen
Dose 1 of Aluminum Adjuvant
Placebo
Low dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
Day 0: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant Day 28: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant
Low dose RSV F Antigen
Dose 2 of Aluminum Adjuvant
Low dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
Day 0: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant
Low dose RSV F Antigen
Dose 3 of Aluminum Adjuvant
Low dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
Day 0: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant
Low dose RSV F Antigen
Dose 4 of Aluminum Adjuvant
High dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant
Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
High dose RSV F Antigen
Dose 2 of Aluminum Adjuvant
Placebo
High dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant
Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
High dose RSV F Antigen
Dose 3 of Aluminum Adjuvant
Placebo
High dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant
Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
High dose RSV F Antigen
Dose 4 of Aluminum Adjuvant
Placebo
Placebo
Day 0: Placebo Day 28: Placebo
Placebo
Interventions
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Low dose RSV F Antigen
High dose RSV F Antigen
Dose 1 of Aluminum Adjuvant
Dose 2 of Aluminum Adjuvant
Dose 3 of Aluminum Adjuvant
Dose 4 of Aluminum Adjuvant
Placebo
Eligibility Criteria
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Inclusion Criteria
1. Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability.
* 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.
2. Willing and able to give informed consent prior to study enrollment.
3. Able to comply with study requirements.
4. 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
1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
2. History of a serious reaction to any prior vaccination.
3. Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
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. Donated blood within 3 weeks of the planned date of first vaccination.
8. 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).
9. Known disturbance of coagulation.
10. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
11. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
12. 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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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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Diablo Clinical Research
Walnut Creek, California, United States
Clincal Research of Atlanta
Stockbridge, Georgia, United States
Advanced Clinical Research
Boise, Idaho, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
QPS Bio-Kinetic
Springfield, Missouri, United States
Wake Research Associates
Raleigh, North Carolina, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Research Across America
Dallas, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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References
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August A, Glenn GM, Kpamegan E, Hickman SP, Jani D, Lu H, Thomas DN, Wen J, Piedra PA, Fries LF. A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age. Vaccine. 2017 Jun 27;35(30):3749-3759. doi: 10.1016/j.vaccine.2017.05.045. Epub 2017 Jun 1.
Other Identifiers
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NVX757.M202
Identifier Type: -
Identifier Source: org_study_id
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