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NCT02289820 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
A Phase 1 study of Respiratory Syncytial Virus (RSV), sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 363
- Enrollment target
- 5
- Study locations
NCT02289820: Completed Phase 1 study of Respiratory Syncytial Virus (RSV), sponsored by MedImmune.
NCT02289820 is a Phase 1 study of Respiratory Syncytial Virus (RSV) that has completed, run by MedImmune. The registered enrollment target is 363 participants, below the 6,723-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02289820, a Phase 1 study of Respiratory Syncytial Virus (RSV), has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 363 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide preliminary safety and immunogenicity data to support concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a dose previously assessed in the Phase 1a study.
Primary Outcome
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to \[\>=\] 100.4°F \[\>=38°C\] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulator
Conditions Studied
Interventions
- BIOLOGICAL MEDI7510
- BIOLOGICAL IIV
Study Locations (5)
Florida
- Research Site - Orlando
- Research Site - South Miami
Missouri
- Research Site - Kansas City
North Carolina
- Research Site - Raleigh
Tennessee
- Research Site - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2015-01-05 |
| Est. Completion | 2016-02-24 |
| Phase | Phase 1 |
What the finished NCT02289820 record still lists
NCT02289820 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, below the 6,723-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Respiratory Syncytial Virus (RSV) appearing as the primary indexed condition, and to 2 interventions - of which MEDI7510 is the first listed.
NCT02289820 lists 5 locations in 4 states (Florida, Missouri, North Carolina).
Frequently Asked Questions
What is clinical trial NCT02289820 about?
NCT02289820 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults". The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide pre...
What is the current status of trial NCT02289820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 363 participants. The study started on 2015-01-05. Estimated completion is 2016-02-24.
What conditions does trial NCT02289820 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).
What interventions are being tested in trial NCT02289820?
The interventions under investigation include: MEDI7510 (BIOLOGICAL), IIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT02289820?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02289820 being conducted?
This trial has 5 study locations across Florida, Missouri, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02289820's enrollment target sits among peer trials
363 6th of 11 higher than 6 of 11 other Respiratory Syncytial Virus (RSV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus (RSV) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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