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This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Active Comparator | Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer |
|
| Treatment Group B | Active Comparator | Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer |
|
| Treatment Group C | Active Comparator | Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1 |
|
| Treatment Group D | Active Comparator | Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer |
|
| Treatment Group E | Active Comparator | Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2 |
|
| Treatment Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV F Vaccine with Aluminum Phosphate Adjuvant | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers to at least one RSV/A strain | Day 0, 21, 28 | |
| Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0. | Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein. | Day 0, 21, 28, 56, 119, 385 | |
| Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. | Day 0, 21, 28, 56, 119, 385 |
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Inclusion Criteria:
Males and females 60 through 80 years of age who are ambulatory and live in the community or in an assisted-living facility that provides 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. To complete the consent process, all qualifying subjects will correctly answer at least 4 out of 5 questions of the informed consent form (ICF) comprehension assessment in no more than 2 attempts.
Able to comply with study requirements. As the protocol procedures involve telephone contacts for safety ascertainment, eligible subjects must have a reliable access to a telephone.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development | Novavax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site AU004 | Sydney | New South Wales | Australia | |||
| Research Site AU005 |
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| Active Comparator |
Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer |
|
| Treatment Group G | Active Comparator | Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3 |
|
| Treatment Group H | Active Comparator | Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer |
|
| Treatment Group J | Active Comparator | Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4 |
|
| Treatment Group K | Active Comparator | Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer |
|
| Treatment Group L | Active Comparator | Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5 |
|
| Treatment Group M | Placebo Comparator | Day 0 Phosphate Buffer Day 21 Phosphate Buffer |
|
| RSV F Vaccine | Biological |
|
| Matrix-M1 Adjuvant | Biological |
|
| Phosphate Buffer | Other |
|
| Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides. | Day 0, 7, 28 |
| Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-γ, or TNF-α production (alone or any combination thereof) following in vitro stimulation with RSV F peptides. | Day 0, 7, 28 |
| Herston |
| Queensland |
| 4006 |
| Australia |
| Research Site AU002 | Adelaide | South Australia | 50000 | Australia |
| Research Site AU006 | Prahran | Victoria | 3181 | Australia |
| Resarch Site AU001 | Nedlands | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| C000625666 | Matrix-M |
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