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This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).
Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and in one group placebo) will be used to maintain the study blind; all subjects will receive a complete course of hepatitis A vaccine as a study benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Experimental | Day 0: RSV F Vaccine with adjuvant, Day 28: RSV F Vaccine with adjuvant |
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| Treatment Group B | Experimental | Day 0: RSV F Vaccine with adjuvant, Day 28: Hepatitis A Vaccine |
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| Treatment Group C | Experimental | Day 0: RSV F Vaccine, Day 28: RSV F Vaccine |
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| Treatment Group D | Experimental | Day 0: RSV F Vaccine, Day 28: Hepatitis A Vaccine |
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| Treatment Group E | Placebo Comparator | Day 0: Placebo, Day 28: Hepatitis A Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV F Vaccine with adjuvant (0.5mL injection) | Biological |
| ||
| RSV F Vaccine (0.5mL injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers and percentages of subjects with solicited local and systemic AEs. | Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year. | Up to Day 392 |
| Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample. | Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR) | Up to Day 392 |
| Measure | Description | Time Frame |
|---|---|---|
| Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a competition ELISA assay using known-efficacious prophylactic antibody preparation, or in vitro neutralization assays using at least one prototype RSV/A and RSV/B | Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR) |
| Measure | Description | Time Frame |
|---|---|---|
| Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a direct binding ELISA using an immobilized linear peptide representing the conserved RSV F protein neutralizing antigenic site II. | Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR) | Up to Day 392 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Nigel Thomas, Ph.D. | Novavax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary, Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada | ||
| Dalhousie University, IWK Health Centre- Canadian Center for Vaccinology |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Biological |
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| Hepatitis A Vaccine (0.5mL injection) | Biological |
|
| Placebo (0.5mL injection) | Biological |
|
| Up to Day 392 |
| Halifax |
| Nova Scotia |
| B3K 6R8 |
| Canada |
| Aggarwal and Associates | Brampton | Ontario | L6T 0G1 | Canada |
| Medicore Research, Inc | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| D007267 | Injections |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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