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| Name | Class |
|---|---|
| PATH | OTHER |
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The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Low dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28) |
|
| Group B | Experimental | Low dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28) |
|
| Group C | Experimental | Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28) |
|
| Group D | Experimental | Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28) |
|
| Group E | Experimental | High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28) |
|
| Group F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose RSV-F Vaccine with Adjuvant | Biological | 0.5mL IM Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups | Immunogenicity will be measured using derived / calculated endpoints based on:
| Day 0 to Day 112 |
| Assessment of the safety | Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for six months | Day 0 to Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity based on neturalizing antibody titer | Day 0 to Day 112 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Nigel Thomas, Ph.D. | Novavax, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| Accelovance Rockville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26259809 | Derived | 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. |
| Label | URL |
|---|---|
| Novavax Homepage | View source |
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High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28) |
|
| Group G | Experimental | High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28) |
|
| Group H | Experimental | High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28) |
|
| Group J | Experimental | Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (Day 0 & Day 28) |
|
| Group K | Placebo Comparator | Placebo (Day 0 and Day 28) |
|
| Low dose RSV-F Vaccine without Adjuvant |
| Biological |
0.5ml IM Injection |
|
| High dose RSV-F Vaccine with Adjuvant | Biological | 0.5mL IM Injection |
|
| High dose RSV-F Vaccine without Adjuvant | Biological | 0.5mL IM Injection |
|
| Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] | Biological | 0.5mL IM Injection |
|
| Placebo | Biological | 0.5mL IM Injection |
|
| Rockville |
| Maryland |
| 20850 |
| United States |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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