Influenza A H3N2NCT06613737
Dose, Safety, and Pathogenicity of a New Influenza A H3N2 Challenge Strain
A study testing Influenza A H3N2 virus dose arm 1, Influenza A H3N2 virus dose arm 2 and Influenza A H3N2 virus dose arm 3 in people with Influenza A H3N2, run by Hvivo at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A H3N2
- What is being tested?
- Influenza A H3N2 virus dose arm 1, Influenza A H3N2 virus dose arm 2 and Influenza A H3N2 virus dose arm 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Sep 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Adult male or female aged between 18 and 55 years
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
- Documented medical history
- Adherence to contraception requirements
- Serosuitable for the challenge virus
Who cannot join
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active disease.
- Any participants who have smoked ≥10 pack years at any time.
- Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
- Any history of anaphylaxis and/or a any history of severe allergic reaction.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
Show all 18Show fewer
- Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction.
- Significant abnormality of the nose, includes loss of or alterations in smell or taste, nasal polyps, epistaxis, nasal or sinus surgery.
- Recent vaccinations or intention to receive vaccination before the Day 28 follow up visit.
- Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned inoculation or planned during the 3 months after the final visit.
- Recent receipt of investigational drugs or challenge viruses.
- Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows.
- Positive drugs of abuse test, recent history or presence of alcohol addiction, excessive consumption of xanthine containing substances or a presence of significant signs and symptoms of nicotine withdrawal on first study visit.
- A forced expiratory volume in 1 second (FEV1) <80%.
- Positive HIV, hepatitis B virus, or hepatitis C virus test.
- Presence of fever, defined as participant presenting with a temperature reading of ≥37.9°C on Day -2/-1 and/or pre-inoculation on Day 0.
- Those employed or immediate relatives of those employed at hVIVO or the sponsor.
- Any other reason, in the opinion of the investigator deems the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
hVIVO Services Ltd, 40 Bank Street
London, E14 5NR
About this study
Official title: 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
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)
Read the detailed description
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.
- Conditions
- Influenza A H3N2
- Being tested
- Influenza A H3N2 virus dose arm 1, Influenza A H3N2 virus dose arm 2, Influenza A H3N2 virus dose arm 3
- Keywords
- Influenza, Flu, H3N2, Human Challenge Trial
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A H3N2 virus dose arm 1Other
Medium dose, approximately 10^4.5 TCID50/mL
Influenza A H3N2 virus dose arm 2Other
High dose, approximately 10^5.5 TCID50/mL
Influenza A H3N2 virus dose arm 3Other
TBD, depending on outcome of Part A
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Influenza A H3N2 virus dose arm 1 |
| 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) Receives: Other: Influenza A H3N2 virus dose arm 2 |
| Dose 3 | Experimental | Optional: TBD, depending on outcome of Part A Receives: Other: Influenza A H3N2 virus dose arm 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Day 1 to Day 8
Secondary outcomes (14)
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).
Measured: Day 1 to Day 8
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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start11 Sep 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza A H3N2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Lima, MD-PhD, Principal investigator, hVIVO Services Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613737
- Sponsor's protocol ID
- HRD-vCS-006
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2024
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06613737
- Acronym / sponsor ID
- HRD-vCS-006
- Conditions
- Influenza A H3N2
- Keywords
- Influenza, Flu, H3N2, Human Challenge Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Other: Influenza A H3N2 virus dose arm 1Medium 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 | Other: Influenza A H3N2 virus dose arm 2High 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 | Other: Influenza A H3N2 virus dose arm 3Optional: TBD, depending on outcome of Part A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Adult male or female aged between 18 and 55 years
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
- Documented medical history
Key exclusion criteria (18 listed)
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active disease.
- Any participants who have smoked ≥10 pack years at any time.
- Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
- Any history of anaphylaxis and/or a any history of severe allergic reaction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza A H3N2 virus dose arm 1Medium dose, approximately 10^4.5 TCID50/mL | Other | Dose 1 |
| Influenza A H3N2 virus dose arm 2High dose, approximately 10^5.5 TCID50/mL | Other | Dose 2 |
| Influenza A H3N2 virus dose arm 3TBD, depending on outcome of Part A | Other | Dose 3 |
Primary outcome
Occurrence of Adverse Events Related to the Viral Challenge
Time frame: Day 0 to Day 28
Occurrence of adverse events (AEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit.
Occurrence of Serious Adverse Events Related to the Viral Challenge
Time frame: Day 0 to Day 28
Occurrence of serious adverse events (SAEs) related to the viral challenge from viral challenge (Day 0) to the Day 28 follow-up visit.
Induces Laboratory-confirmed Infection in ≥40% of Inoculated Participants
Time frame: Day 1 to Day 8
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).
14 secondary outcomes
Incidence of Viral Culture-confirmed Influenza Infection.
Time frame: Day 1 to Day 8
VL-AUC of Influenza Challenge Virus as Determined by qRT-PCR
Time frame: Day 1 to Day 8
Peak Viral Load of Influenza Challenge Virus as Determined by qRT-PCR
Time frame: Day 1 to Day 8
VL-AUC of Influenza Challenge Virus as Determined by Viral Culture
Time frame: Day 1 to Day 8
Peak Viral Load of Influenza Challenge Virus as Determined by Viral Culture
Time frame: Day 1 to Day 8
Area Under the Total Clinical Symptoms Score-time Curve (TSS-AUC)
Time frame: Day 1 to Day 8
Peak Total Symptoms Diary Card Score
Time frame: Day 1 to Day 8
Peak Daily Symptoms Diary Card Score
Time frame: Day 1 to Day 8
Laboratory-confirmed Febrile Influenza Infection
Time frame: Day 1 to Day 8
qRT-PCR-confirmed Influenza-like Illness (Centers for Disease and Control [CDC])
Time frame: Day 1 to Day 8
qRT-PCR-confirmed Influenza-like Illness (World Health Organization [WHO])
Time frame: Day 1 to Day 8
Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection
Time frame: Day 1 to Day 8
Laboratory-confirmed Symptomatic Influenza Infection
Time frame: Day 1 to Day 8
Viral Culture Laboratory-confirmed Moderately Severe Symptomatic Influenza Infection
Time frame: Day 1 to Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Lima, MD-PhD principal investigator
hVIVO Services Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza A H3N2 virus dose arm 1, Influenza A H3N2 virus dose arm 2 and Influenza A H3N2 virus dose arm 3 in people with Influenza A H3N2, run by Hvivo at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events Related to the Viral Challenge (time frame: Day 0 to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.