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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Columbia University | OTHER |
| Emory University |
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This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other vaccines at separate visits (Visits 1 and 2).
Parent(s) or legal guardians will assess fever and other solicited local and systemic adverse events on the day of immunization (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous Immunization | Experimental | The simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1. |
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| Sequential Immunization | Experimental | The sequential immunization group will receive routine childhood vaccinations at Visit 1, followed by respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody | Drug | ACIP Recommended Preventive Monoclonal Antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Fever Following Immunization | Number of infants with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2. | Up to 2 days post administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 | Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F) | Up to 2 days post administration |
| Number of Participants with Grade 2 and/or 3 Fever Following Visit 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael J Smith, MD | Contact | 919 684 6335 | michael.j.smith@duke.edu | |
| Emily A Randolph, MBA | Contact | 919 385 5785 | emily.randolph@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael J Smith, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Recruiting | Oakland | California | 94612 | United States |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000709769 | nirsevimab |
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| OTHER |
| Kaiser Permanente | OTHER |
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Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F) |
| Up to 2 days post administration |
| The Number of Participants with At Least One Serious Adverse Event | Up to 98 days post administration |
| The Number of Participants with At Least One Adverse Event of Special Interest | Up to 98 days post administration |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Centers for Disease Control and Prevention | Active, not recruiting | Atlanta | Georgia | 30333 | United States |
| Columbia University | Recruiting | New York | New York | 10027 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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