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An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a New Influenza A H3N2 Challenge Strain in Healthy Participants 18 to 55 Years of Age
In Part A, up to 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2).
Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3)
This is an exploratory study of an influenza A/England/7763/2022 H3N2 challenge strain, to determine the optimum safe infectious titer of challenge agent, in healthy participants 18 to 55 years of age.
A total of up to 80 participants may be given the influenza A/England/7763/2022 H3N2 challenge agent. Each participant will remain in the study for approximately 4 months from screening to the last clinic visit.
The study will consist of 2 parts, in Part A of the study, up to 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2). Based on the outcome of Part A, additional participants may be enrolled into the optional Part B of the study and may be given Virus Dose 1, Virus Dose 2, and/or another virus dose (e.g., Virus Dose 3)
The study is divided into three phases:
Screening phase: Screening will occur between Day -90 to Day -2/-1.
Quarantine phase: Participants will stay in the quarantine unit for approximately 8 days (from Day -2/-1 to Day 8).
One or two days prior to the day of inoculation with the challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remain eligible for the study, they will receive the challenge virus on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 8 (or may remain longer at the principal investigator's discretion).
Outpatient phase: Following the conclusion of the quarantine phase, participants will attend a Follow-Up visit, approximately 28 days after they received the study virus. Their symptoms will be reassessed, and a complete safety examination performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Medium dose, expected to be approximately 10^4.5 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) |
|
| Dose 2 | Experimental | High dose, expected to be approximately 10^5.5 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) |
|
| Dose 3 | Experimental | Optional: TBD, depending on outcome of Part A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza A H3N2 virus dose arm 1 | Other | Medium dose, approximately 10^4.5 TCID50/mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events Related to the Viral Challenge | Occurrence of adverse events (AEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit. | Day 0 to Day 28 |
| Occurrence of Serious Adverse Events Related to the Viral Challenge | Occurrence of serious adverse events (SAEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit. | Day 0 to Day 28 |
| Induces Laboratory-confirmed Infection in ≥40% of Inoculated Participants | Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed influenza infection, defined as 2 quantifiable (≥ lower limit of quantification [LLOQ]) qRT-PCR measurements (reported over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Viral Culture-confirmed Influenza Infection. | Viral culture-confirmed influenza infection, defined as a quantifiable viral culture measurement, from Day 1 pm to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| VL-AUC of Influenza Challenge Virus as Determined by qRT-PCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Lima, MD-PhD | hVIVO Services Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hVIVO Services Ltd, 40 Bank Street | London | E14 5NR | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medium Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10^4.5 TCID50/mL, pipette administration. |
| FG001 | Medium Dose, MAD Administration. | Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10^4.5 TCID50/mL, Mucosal Atomization Device® [MAD] administration. |
| FG002 | High Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 3: High dose, approximately 10^5.5 TCID50/mL, pipette administration. |
| FG003 | High Dose, MAD Administration. | Influenza A H3N2 virus dose arm 4: High dose, approximately 10^5.5 TCID50/mL, Mucosal Atomization Device® [MAD] administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medium Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10^4.5 TCID50/mL, pipette administration. |
| BG001 | Medium Dose, MAD Administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Adverse Events Related to the Viral Challenge | Occurrence of adverse events (AEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit. | Posted | Number | Occurrence of adverse events | Day 0 to Day 28 |
|
Challenge agent-emergent adverse events were collected from inoculation of the challenge virus till the day 28 follow up visit (29 days).
Systematic Assessment collection via routine safety assessments (ECGs, Physical assessments, 3 times daily Symptom Dairy Cards,...
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medium Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 1: Medium dose, approximately 10^4.5 TCID50/mL, pipette administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Mann | hVIVO Services Ltd. | +44 (0) 20 7756 1300 | projectadmin@hvivo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2024 | Apr 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Influenza A H3N2 virus dose arm 2 |
| Other |
High dose, approximately 10^5.5 TCID50/mL |
|
| Influenza A H3N2 virus dose arm 3 | Other | TBD, depending on outcome of Part A |
|
Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by qRT-PCR on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am) |
| Day 1 to Day 8 |
| Peak Viral Load of Influenza Challenge Virus as Determined by qRT-PCR | Peak viral load of influenza challenge virus defined as the maximum viral load, from qRT-PCR on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| VL-AUC of Influenza Challenge Virus as Determined by Viral Culture | Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by viral culture on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am) | Day 1 to Day 8 |
| Peak Viral Load of Influenza Challenge Virus as Determined by Viral Culture | Peak viral load of influenza challenge virus defined as the maximum viral load, from by viral culture on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| Area Under the Total Clinical Symptoms Score-time Curve (TSS-AUC) | Data presented is score*days. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day 1 am up to Day 8 am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 22, the maximum time period is 7 days. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). The range of TSS AUC scores are between 0 and 287 score*days (maximum of 41*7). | Day 1 to Day 8 |
| Peak Total Symptoms Diary Card Score | Peak Total Symptom Score (TSS) for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day 1) up to discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). | Day 1 to Day 8 |
| Peak Daily Symptoms Diary Card Score | Peak daily symptom score was derived, for each day from Day 1 to Day 8, as the maximum of the 3 total symptoms scores on that day. The symptoms were collected three times daily starting one day post-viral challenge (Day 1) up to planned discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). | Day 1 to Day 8 |
| Laboratory-confirmed Febrile Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.9°C, from Day 1 am to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| qRT-PCR-confirmed Influenza-like Illness (Centers for Disease and Control [CDC]) | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.8ºC, and a cough and/or sore throat (symptoms and signs), from Day 1 am to planned discharge from quarantine (Day 8 am), in the absence of a known cause other than influenza. | Day 1 to Day 8 |
| qRT-PCR-confirmed Influenza-like Illness (World Health Organization [WHO]) | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥38.0ºC and a cough, from Day 1 am to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| Laboratory-confirmed Symptomatic Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a total symptom score of ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
| Viral Culture Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection | Viral culture laboratory-confirmed infection, AND any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Day 1 to Day 8 |
Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10^4.5 TCID50/mL, MAD administration.
| BG002 | High Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 3: High dose, approximately 10^5.5 TCID50/mL, pipette administration. |
| BG003 | High Dose, MAD Administration. | Influenza A H3N2 virus dose arm 3: High dose, approximately 10^5.5 TCID50/mL, MAD administration. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| High Dose, Pipette Administration. |
Influenza A H3N2 virus dose arm 3: High dose, approximately 10^5.5 TCID50/mL, pipette administration. |
| OG003 | High Dose, MAD Administration. | Influenza A H3N2 virus dose arm 4: High dose, approximately 10^5.5 TCID50/mL, MAD administration. |
|
|
| Primary | Occurrence of Serious Adverse Events Related to the Viral Challenge | Occurrence of serious adverse events (SAEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit. | Posted | Number | Occurrence of serious adverse events | Day 0 to Day 28 |
|
|
|
| Primary | Induces Laboratory-confirmed Infection in ≥40% of Inoculated Participants | Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed influenza infection, defined as 2 quantifiable (≥ lower limit of quantification [LLOQ]) qRT-PCR measurements (reported over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
|
| Secondary | Incidence of Viral Culture-confirmed Influenza Infection. | Viral culture-confirmed influenza infection, defined as a quantifiable viral culture measurement, from Day 1 pm to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
|
| Secondary | VL-AUC of Influenza Challenge Virus as Determined by qRT-PCR | Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by qRT-PCR on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am) | Posted | Mean | Standard Deviation | log10 copies/mL*days | Day 1 to Day 8 |
|
|
|
| Secondary | Peak Viral Load of Influenza Challenge Virus as Determined by qRT-PCR | Peak viral load of influenza challenge virus defined as the maximum viral load, from qRT-PCR on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am). | Posted | Mean | Standard Deviation | log10 copies/mL | Day 1 to Day 8 |
|
|
|
| Secondary | VL-AUC of Influenza Challenge Virus as Determined by Viral Culture | Area under the viral load-time curve (VL-AUC) of influenza challenge virus as determined by viral culture on both nasal and throat (Part B only) samples, starting from Day 1 pm up to planned discharge from quarantine (Day 8 am) | Posted | Mean | Standard Deviation | log10TCID50/mL*days | Day 1 to Day 8 |
|
|
|
| Secondary | Peak Viral Load of Influenza Challenge Virus as Determined by Viral Culture | Peak viral load of influenza challenge virus defined as the maximum viral load, from by viral culture on nasal and throat (Part B only) samples from Day 1 pm to planned discharge from quarantine (Day 8 am). | Posted | Mean | Standard Deviation | log10TCID50/mL | Day 1 to Day 8 |
|
|
|
| Secondary | Area Under the Total Clinical Symptoms Score-time Curve (TSS-AUC) | Data presented is score*days. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day 1 am up to Day 8 am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 22, the maximum time period is 7 days. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). The range of TSS AUC scores are between 0 and 287 score*days (maximum of 41*7). | Posted | Mean | Standard Deviation | score*days | Day 1 to Day 8 |
|
|
|
| Secondary | Peak Total Symptoms Diary Card Score | Peak Total Symptom Score (TSS) for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day 1) up to discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). | Posted | Mean | Standard Deviation | Peak TSS | Day 1 to Day 8 |
|
|
|
| Secondary | Peak Daily Symptoms Diary Card Score | Peak daily symptom score was derived, for each day from Day 1 to Day 8, as the maximum of the 3 total symptoms scores on that day. The symptoms were collected three times daily starting one day post-viral challenge (Day 1) up to planned discharge from quarantine (Day 8 am) using a participant self-reportable 13-symptoms card. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle and/or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) to 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). | Posted | Mean | Standard Deviation | Peak TSS | Day 1 to Day 8 |
|
|
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| Secondary | Laboratory-confirmed Febrile Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.9°C, from Day 1 am to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
|
| Secondary | qRT-PCR-confirmed Influenza-like Illness (Centers for Disease and Control [CDC]) | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥37.8ºC, and a cough and/or sore throat (symptoms and signs), from Day 1 am to planned discharge from quarantine (Day 8 am), in the absence of a known cause other than influenza. | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
|
| Secondary | qRT-PCR-confirmed Influenza-like Illness (World Health Organization [WHO]) | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a febrile episode, defined as a temperature of ≥38.0ºC and a cough, from Day 1 am to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
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| Secondary | Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
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| Secondary | Laboratory-confirmed Symptomatic Influenza Infection | A qRT-PCR-confirmed influenza infection, defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements (reported on 2 or more independent samples over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 8 am) AND, a total symptom score of ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
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| Secondary | Viral Culture Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection | Viral culture laboratory-confirmed infection, AND any symptoms from the symptom diary card of grade ≥2 at a single time point, from Day 1 am to planned discharge from quarantine (Day 8 am). | Posted | Count of Participants | Participants | Day 1 to Day 8 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Medium Dose, MAD Administration. | Influenza A H3N2 virus dose arm 2: Medium dose, approximately 10^4.5 TCID50/mL, MAD administration. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | High Dose, Pipette Administration. | Influenza A H3N2 virus dose arm 3: High dose, approximately 10^5.5 TCID50/mL, pipette administration. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | High Dose, MAD Administration. | Influenza A H3N2 virus dose arm 4: High dose, approximately 10^5.5 TCID50/mL, MAD administration. | 0 | 19 | 0 | 19 | 9 | 19 |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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