Trial · NCT03969212
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
NCT03969212, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-04-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households. Trials, record NCT03969212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03969212
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
- NCT number
- NCT03969212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,138 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Influenza
- Interventions
- Baloxavir Marboxil, Placebo
- First posted
- 2019-05-31
- Last updated
- 2025-07-04
- Other registries' IDs
- eudract:2018-004056-37
- Results first posted
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of HHCs With Virological Influenza Transmission by Day 5 | Baseline (Day 1) to Day 5 | 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 estimating equations (GEE) approach. |
| Secondary | Percentage of HHCs With Symptomatic Influenza Transmission by Day 5 | Baseline (Day 1) to Day 5 | 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 respective IP, \& developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years old were symptomatic if 1. Presence of temperature ≥38.0 Celsius (C) and 1 respiratory symptom (cough, sore throat, nasal congestion) or 2. Presence of 1 respiratory symptom and 1 general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with/without a fever. HHCs ≥2 and \<12 years old were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory tract infection signs or symptoms (cough, nasal congestion, or rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity. |
| Secondary | Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5 | Baseline (Day 1) to Day 5 | Percentage of households with at least one HHC who met the primary endpoint of virological transmission by Day 5 are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set. |
| Secondary | Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5 | Baseline (Day 1) to Day 5 | Percentage of HHs with at least one HHC who meets the symptomatic transmission by Day 5 endpoint are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set. |
| Secondary | Percentage of HHCs With Virological Influenza Transmission by Day 9 | Baseline (Day 1) to Day 9 | The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization with virus subtype matching with the respective IP, irrespective of being symptomatic or asymptomatic including: 1. all HHC meeting primary endpoint, AND 2. all HHC cases detected after Day 5 meeting the following criteria: 2a. included HHC case was in an HH where another HHC had already met the primary endpoint OR 2b. included HHC case was PCR+ bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein (PA/I38X substitution) or amino acid substitution of threonine to lysine at position 20 in the PA protein for influenza B only (PA/T20K). The adjusted incidence rates presented were estimated using a GEE approach. |
| Secondary | Percentage of HHCs With Symptomatic Influenza Transmission by Day 9 | Baseline (Day 1) to Day 9 | The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological transmission by Day 9 endpoint and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had 1. temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or 2. one respiratory and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (headache, feverishness or chills, muscle or joint pain, fatigue). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity. |
| Secondary | Percentage of HHCs With Any Virological Infection by Day 9 | Baseline (Day 1) to Day 9 | Virological infection was defined as HHCs who tested PCR+ for influenza by Day 9 post IP randomization based on PCR influenza test results. The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological infection by Day 9 endpoint. The adjusted incidence rates presented were estimated using a GEE approach. |
| Secondary | Percentage of HHs With Any Virological Infection at HH Level by Day 9 | Baseline (Day 1) to Day 9 | Virological infection at the HH level was defined as the HHs with at least one HHC who met the endpoint of any virological infection by Day 9. 'Number of participants analyzed' is the number of IPs in the PAS-IP set. |
| Secondary | Percentage of HHCs With Any Symptomatic Infection by Day 9 | Baseline (Day 1) to Day 9 | The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had (1) a temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or (2) one respiratory and one systemic symptom (headache, chills, muscle/joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity. |
| Secondary | Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9 | Baseline (Day 1) to Day 9 | Percentage of HHs with at least one HHC who meets the endpoint of any symptomatic infection by Day 9 are reported here. HHCs ≥12 years were symptomatic if they had 1. a temperature ≥38.0°C \&1 respiratory symptom (cough, sore throat, nasal congestion) or 2. 1 respiratory \& 1 systemic symptom (headache, chills, muscle/joint pain, fatigue), with/without fever. HHCs ≥2 \& \<12 years were symptomatic if the temperature was ≥38.0°C \& had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be new or have worsened versus baseline in HHC with baseline symptoms due to preexisting comorbidity. 'Number of participants analyzed' is the number of IPs in the PAS-IP set. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of HHCs With Virological Influenza Transmission by Day 5 | Baseline (Day 1) to Day 5 | The primary household contacts analysis set (PAS-HC) included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of HHCs With Symptomatic Influenza Transmission by Day 5 | Baseline (Day 1) to Day 5 | PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5 | Baseline (Day 1) to Day 5 | Primary Households Analysis Set (PAS-HH) included all households of randomized IPs that were PCR+ at screening and with at least one HHC enrolled for the full study. IPs should be a part of the Primary Index Patients Analysis Set (PAS-IP) which includes all randomized IPs with at least 1 HHC in the PAS-HC. PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A/B, received study drug, and where all contacts were PCR negative at baseline. | percentage of HHs | NUMBER |
| SECONDARY | Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5 | Baseline (Day 1) to Day 5 | PAS-HH included all households of randomized IPs that were PCR+ at screening and with at least one HHC enrolled for the full study. The IPs should be a part of the PAS-IP which includes all randomized IPs with at least one HHC in the PAS-HC. PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. | percentage of HHs | NUMBER |
| SECONDARY | Percentage of HHCs With Virological Influenza Transmission by Day 9 | Baseline (Day 1) to Day 9 | PAS-HC analysis set included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. Overall number analyzed included number of HHCs with data available for analysis. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of HHCs With Symptomatic Influenza Transmission by Day 9 | Baseline (Day 1) to Day 9 | PAS-HC included unvaccinated HHCs who were linked to households where IP was baseline PCR+ for influenza A or B, received study drug, and where all contacts were PCR negative at baseline. Overall number analyzed is the number of participants with data available for analysis. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of HHCs With Any Virological Infection by Day 9 | Baseline (Day 1) to Day 9 | PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B and received study drug and where all contacts were PCR negative at baseline. Overall number analyzed is the number of participants with data available for analysis. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of HHs With Any Virological Infection at HH Level by Day 9 | Baseline (Day 1) to Day 9 | PAS-HH included all households of randomized IPs that were PCR+ at screening and with at least one HHC enrolled for the full study. The IPs should be a part of the PAS-IP which includes all randomized IPs with at least one HHC in the PAS-HC. PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. | percentage of HHs | NUMBER |
| SECONDARY | Percentage of HHCs With Any Symptomatic Infection by Day 9 | Baseline (Day 1) to Day 9 | PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B and received study drug and where all contacts were PCR negative at baseline. Overall number analyzed is the number of participants with data available for analysis. | percentage of HHCs | NUMBER |
| SECONDARY | Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9 | Baseline (Day 1) to Day 9 | PAS-HH included all households of randomized IPs that were PCR+ at screening and with at least one HHC enrolled for the full study. The IPs should be a part of the PAS-IP which includes all randomized IPs with at least one HHC in the PAS-HC. PAS-HC included unvaccinated HHCs who were linked to households where the IP was baseline PCR+ for influenza A or B, received the study drug, and where all contacts were PCR negative at baseline. | percentage of HHs | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of HHCs With Virological Influenza Transmission by Day 5 | Placebo: HHCs | 13.42 | 95.38% Confidence Interval 10.66 to 16.76 | percentage of HHCs | |
| Percentage of HHCs With Virological Influenza Transmission by Day 5 | Baloxavir Marboxil: HHCs | 9.50 | 95.38% Confidence Interval 7.40 to 12.13 | percentage of HHCs | |
| Percentage of HHCs With Symptomatic Influenza Transmission by Day 5 | Placebo: HHCs | 7.61 | 95.38% Confidence Interval 5.66 | percentage of HHCs | |
| Percentage of HHCs With Symptomatic Influenza Transmission by Day 5 | Baloxavir Marboxil: HHCs | 5.80 | 95.38% Confidence Interval 4.10 | percentage of HHCs | |
| Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5 | Placebo: IPs | 19.5 | percentage of HHs | ||
| Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5 | Baloxavir Marboxil: IPs | 15.5 | percentage of HHs | ||
| Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5 | Placebo: IPs | 11.9 | percentage of HHs | ||
| Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5 | Baloxavir Marboxil: IPs | 8.6 | percentage of HHs | ||
| Percentage of HHCs With Virological Influenza Transmission by Day 9 | Placebo: HHCs | 15.40 | 95.38% Confidence Interval 12.20 | percentage of HHCs | |
| Percentage of HHCs With Virological Influenza Transmission by Day 9 | Baloxavir Marboxil: HHCs | 10.77 | 95.38% Confidence Interval 8.41 | percentage of HHCs |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo: IPs | 731 | |
| Overall Study | STARTED | Baloxavir Marboxil: IPs | 726 | |
| Overall Study | STARTED | Placebo: HHCs | 1,336 | |
| Overall Study | STARTED | Baloxavir Marboxil: HHCs | 1,345 | |
| Overall Study | Treated | Placebo: IPs | 726 | |
| Overall Study | Treated | Baloxavir Marboxil: IPs | 723 | |
| Overall Study | Treated | Placebo: HHCs | 0 | |
| Overall Study | Treated | Baloxavir Marboxil: HHCs | 0 | |
| Overall Study | COMPLETED | Placebo: IPs | 699 | |
| Overall Study | COMPLETED | Baloxavir Marboxil: IPs | 688 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Bronchitis | Infections and infestations | Placebo: IPs | 1 | 726 | 1 |
| serious | Bronchitis | Infections and infestations | Baloxavir Marboxil: IPs | 0 | 723 | 0 |
| serious | Pneumonia | Infections and infestations | Placebo: IPs | 1 | 726 | 1 |
| serious | Pneumonia | Infections and infestations | Baloxavir Marboxil: IPs | 0 | 723 | 0 |
| serious | Hyponatraemia | Metabolism and nutrition disorders | Placebo: IPs | 1 | 726 | 1 |
| serious | Hyponatraemia | Metabolism and nutrition disorders | Baloxavir Marboxil: IPs | 0 | 723 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Placebo: IPs | 0 | 726 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Baloxavir Marboxil: IPs | 1 | 723 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo: IPs | 0 | 726 |
| Total, all-cause mortality | Baloxavir Marboxil: IPs | 0 | 723 |
| Total, other adverse events | Placebo: IPs | 0 | 726 |
| Total, other adverse events | Baloxavir Marboxil: IPs | 0 | 723 |
| Total, serious adverse events | Placebo: IPs | 2 | 726 |
| Total, serious adverse events | Baloxavir Marboxil: IPs | 1 | 723 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo: IPs vs Baloxavir Marboxil: IPs: Number of IPs With Serious Adverse Events (SAEs) | Trial comparisons |
| Placebo: IPs vs Baloxavir Marboxil: IPs: Number of IPs With Adverse Events (AEs) | Trial comparisons |
| Placebo: IPs vs Baloxavir Marboxil: IPs: deaths from any cause | Trial comparisons |
| Placebo: IPs vs Baloxavir Marboxil: IPs: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03969212
GET https://conductscience.org/api/trials/v1/NCT03969212/results?page=2