Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Public ClinicalTrials.gov record NCT03969212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
Study identification
- NCT ID
- NCT03969212
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,138 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 10, 2019 (Actual)
- Primary completion
- May 10, 2024 (Actual)
- Completion
- May 10, 2024 (Actual)
- Last update posted
- Jul 4, 2025
2019 – 2024
United States locations
- U.S. sites
- 43
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Research, Inc. | Birmingham | Alabama | 35235 | — |
| Cahaba Research, Inc | Pelham | Alabama | 35124 | — |
| Precision Trials | Phoenix | Arizona | 85032 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| Long Beach Clinical Trials | Long Beach | California | 90806 | — |
| Downtown LA Research Center | Los Angeles | California | 90017 | — |
| Probe Clinical Research | Riverside | California | 92501 | — |
| MD Strategies Research Centers | San Diego | California | 92119 | — |
| Cherry Creek Family Practice | Denver | Colorado | 80246 | — |
| Proactive Clinical Research, LLC | Fort Lauderdale | Florida | 33308 | — |
| Helios Clinical Research, Inc (former Ventavia Research Group) | Kissimmee | Florida | 34744 | — |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | — |
| Cordova Research Institute, LLC | Miami | Florida | 33155 | — |
| Research Institute of South Florida Inc | Miami | Florida | 33173 | — |
| Kendall South Medical Center Inc. | South Miami | Florida | 33185 | — |
| Agile Clinical Research Trials | Atlanta | Georgia | 30328 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Mishawaka Osteopathic Clinic | Mishawaka | Indiana | 46544 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercury Street Medical Group | Butte | Montana | 59701 | — |
| Montana Medical Research LLC | Missoula | Montana | 59808 | — |
| Accent Clinical Trials | Las Vegas | Nevada | 89104 | — |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | — |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | 28277 | — |
| Burke Primary Care | Morganton | North Carolina | 28655 | — |
| Hometown Urgent Care and Occupational Health - Springdale | Cincinnati | Ohio | 45215 | — |
| Tristar Clinical Investigations | Philadelphia | Pennsylvania | 19114 | — |
| Frontier Clinical Research | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research | Smithfield | Pennsylvania | 15478 | — |
| Frontier Clinical Research | Smithfield | Pennsylvania | 26505 | — |
| Jedda Enterprises dba Galen Clinical Research | Greer | South Carolina | 29651 | — |
| AFC Urgent Care-Gunbarrell | Chattanooga | Tennessee | 37421 | — |
| Helios Clinical Research, Inc (former Ventavia Research Group) | Jackson | Tennessee | 38305 | — |
| City Doc Urgent Care-Dallas/Ft. Worth | Dallas | Texas | 75204 | — |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | — |
| Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas | 75020 | — |
| Pioneer Research Solutions | Houston | Texas | 077099 | — |
| Vilo Research Group | Houston | Texas | 77017 | — |
| Fairway Medical Clinic | Houston | Texas | 77087 | — |
| Mercury Clinical Research | Houston | Texas | 77087 | — |
| Family Practice Center | McAllen | Texas | 78501 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Frontier Clinical Research | Kingwood | West Virginia | 26537 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03969212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03969212 live on ClinicalTrials.gov.