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NCT03969212 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,138
- Enrollment target
NCT03969212: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03969212 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 4,138 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (436% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03969212, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,138 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimati
Interventions
- DRUG Placebo
- DRUG Baloxavir Marboxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,138 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2024-05-10 |
| Phase | Phase 3 |
What the finished NCT03969212 record still lists
NCT03969212 is an interventional study that assigns participants to a tested intervention. Its 4,138 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (436% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03969212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03969212 about?
NCT03969212 is a clinical study titled "Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households". 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 w...
What is the current status of trial NCT03969212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,138 participants. The study started on 2019-10-10. Estimated completion is 2024-05-10.
What interventions are being tested in trial NCT03969212?
The interventions under investigation include: Placebo (DRUG), Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT03969212?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03969212's enrollment target sits among peer trials
4,138 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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