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History of Changes for Study: NCT01960686
RSV F Dose-Ranging Study in Women
Latest version (submitted April 27, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2013 None (earliest Version on record)
2 October 18, 2013 Recruitment Status, Contacts/Locations and Study Status
3 September 12, 2014 Recruitment Status, Study Status and Study Design
4 September 23, 2014 Study Status
5 October 15, 2015 Study Status
6 March 21, 2016 Study Status
7 April 27, 2016 Arms and Interventions and Study Status
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Study NCT01960686
Submitted Date:  October 9, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: NVX757.M202
Brief Title: RSV F Dose-Ranging Study in Women
Official Title: A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2013
Overall Status: Recruiting
Study Start: October 2013
Primary Completion: April 2014 [Anticipated]
Study Completion: April 2014 [Anticipated]
First Submitted: October 8, 2013
First Submitted that
Met QC Criteria:
October 9, 2013
First Posted: October 11, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 9, 2013
Last Update Posted: October 11, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novavax
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
Detailed Description:
Open or close this module Conditions
Conditions: Respiratory Syncytial Virus Infections
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 8
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 720 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Low dose RSV F Vaccine with Dose 1 of Adjuvant
Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
Biological: Low dose RSV F AntigenBiological: Dose 1 of AdjuvantBiological: Placebo
Experimental: Low dose RSV F Vaccine with Dose 2 of 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
Biological: Low dose RSV F AntigenBiological: Dose 2 of Adjuvant
Experimental: Low dose RSV F Vaccine with Dose 3 of 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
Biological: Low dose RSV F AntigenBiological: Dose 3 of Adjuvant
Experimental: Low dose RSV F Vaccine with Dose 4 of 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
Biological: Low dose RSV F AntigenBiological: Dose 4 of Adjuvant
Experimental: High dose RSV F Vaccine with Dose 2 of Adjuvant
Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F AntigenBiological: Dose 2 of AdjuvantBiological: Placebo
Experimental: High dose RSV F Vaccine with Dose 3 of Adjuvant
Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F AntigenBiological: Dose 3 of AdjuvantBiological: Placebo
Experimental: High dose RSV F Vaccine with Dose 4 of Adjuvant
Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F AntigenBiological: Dose 4 of AdjuvantBiological: Placebo
Placebo Comparator: Placebo
Day 0: Placebo Day 28: Placebo
Biological: Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups
[ Time Frame: Day 0 to Day 56 ]

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 concentrations as EU (GMEU)
  • Geometric mean ratio (GMR)
  • Geometric mean fold-rise (GMFR)
  • Seroconversion rate (SCR)
  • Seroresponse rate (SRR)
2. Assessment of Safety
[ Time Frame: Day 0 to Day 182 ]

Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.
Secondary Outcome Measures:
1. Immunogenicity based on neutralizing antibody titer
[ Time Frame: Day 0 to Day 56 ]

2. Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time
[ Time Frame: Day 0 to Day 91 ]

3. Immunogenicity based on antibodies sharing specificity with Palivizumab
[ Time Frame: Day 0 to 91 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 35 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

Subjects must meet the following criteria to be eligible to participate:

  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:

Subjects will be excluded if they fulfill any of the following 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).
Open or close this module Contacts/Locations
Central Contact Person: D. Nigel Thomas, Ph.D.
Telephone: 240-268-2023
Email: nthomas@novavax.com
Study Officials: D. Nigel Thomas, Ph.D.
Study Director
Novavax, Inc.
Locations: United States, California
Diablo Clinical Research
[Recruiting]
Walnut Creek, California, United States, 94598
Contact:Contact: Lana Norman 925-930-7267 lnorman@diabloclinical.com
Contact:Principal Investigator: Helen Stacey, MD
United States, Georgia
Clincal Research of Atlanta
[Recruiting]
Stockbridge, Georgia, United States, 30281
Contact:Contact: Loletta Smith 770-507-6867 lsmith@clinicalresearchatlanta.net
Contact:Principal Investigator: Nathan Segall, MD
United States, Idaho
Advanced Clinical Research
[Recruiting]
Boise, Idaho, United States, 83642
Contact:Contact: Jessica Walukones 208-377-8653 jwalukones@acr-research.com
Contact:Principal Investigator: Mark Turner, MD
United States, Kansas
Johnson County Clin-Trials
[Recruiting]
Lenexa, Kansas, United States, 66219
Contact:Contact: Nathan Arthur 913-825-4400 narthur@jcct.com
Contact:Principal Investigator: Casey Johnson, DO
United States, Missouri
QPS Bio-Kinetic
[Recruiting]
Springfield, Missouri, United States, 65802
Contact:Contact: Leona McGowen 417-893-6110 leona.mcgowen@qps.com
Contact:Principal Investigator: Donald Burkindine, MD
United States, North Carolina
Wake Research Associates
[Recruiting]
Raleigh, North Carolina, United States, 27612
Contact:Contact: Melissa Braxton 919-781-2514 mbraxton@wakeresearch.com
Contact:Principal Investigator: Wayne Harper, MD
United States, South Carolina
Coastal Carolina Research
[Recruiting]
Mt. Pleasant, South Carolina, United States, 29464
Contact:Contact: Ali Kennedy 843-856-3784 akennedy@coastalcarolinaresearch.com
Contact:Principal Investigator: Cynthia Strout, MD
United States, Texas
Research Across America
[Recruiting]
Dallas, Texas, United States, 75234
Contact:Contact: Matthew Easley 281-579-1938 measley@raasites.com
Contact:Principal Investigator: Joe Blumenau, MD
Clinical Trials of Texas
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Terri Ryan 210-959-0122 tryan@cttexas.com
Contact:Principal Investigator: Dennis Denham, DO
United States, Utah
Jean Brown Research
[Recruiting]
Salt Lake City, Utah, United States, 84124
Contact:Contact: Erika Jones 801-261-2000 ejones@jeanbrownresearch.com
Contact:Principal Investigator: Derek Muse, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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