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CompletedNCT04372719Updated May 4, 2020

A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers

A Phase 1 interventional study of H3N2 in Influenza, Human, sponsored by SGS Life Sciences, a division of SGS Belgium NV. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-04.

Sponsored by SGS Life Sciences, a division of SGS Belgium NV · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Nov 2016, registered Apr 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
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Study summary

This is a non-controlled, open-label, single-centre, dose-escalation study to determine the safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2 A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.

Read the detailed description

In Part 1, the primary objective is to determine the viral challenge strain dose that has an acceptable safety profile and an observed attack rate of >60% (i.e., at least 8 out of 12 subjects should be infected). After Part 1, a formal interim analysis will be performed to select the viral challenge strain dose for Part 2 by evaluating the primary objective of Part 1. In case no viral challenge strain dose can be selected, the study will not proceed to Part 2.

In Part 2, the primary objective is to determine the infectivity rate in healthy volunteers of the selected viral challenge strain dose for use in subsequent human challenge intervention studies.

All subjects will be screened prior to viral inoculation to assess their suitability to enter the study. Eligible subjects will be admitted to the clinical centre for a single intranasal inoculation with influenza A (H3N2). In this study, up to 64 healthy subjects will receive the investigational challenge agent: 36 subjects in Part 1 and 18 or 28 subjects in Part 2.

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Conditions studied

  • Influenza, Human

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 36 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

This is the only study on the registry with SGS Life Sciences, a division of SGS Belgium NV as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female, between 18 and 55 years old (extremes included) at screening.
  2. In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
  3. Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening.
  4. Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site.
  5. Negative alcohol breath test
  6. Female subjects should fulfil one of the following criteria:

    1. At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone (FSH) > 30 mIU/mL) prior to screening;
    2. Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
    3. Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
  7. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge.

Exclusion criteria

Exclusion criteria:

  1. Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study.
  2. Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening.
  3. Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2.
  4. Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator.
  5. Has an acute or chronic medical condition
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Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    H3N2 10EXP5 TCID50/mL

    A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain

    Drug: H3N2

Interventions

  • DrugH3N2
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What researchers measure

Primary outcomes

  1. safety profile

    Number of subjects with SAEs considered by the Investigator to be related to the challenge agent, moderate or severe lower respiratory symptoms as indicated on the symptom score card, or confirmed cytokine-related AEs.

    Time frame: through study completion, an average of 3 months

  2. Efficacy: Infectivity

    Attack rate defined as number of inoculated subjects with any of the following: * Fever * At least one other (i.e., not fever) influenza symptom At least 2 consecutive swabs positive for H3N2

    Time frame: through study completion, an average of 3 months

  3. Efficacy: observed attack rate

    Observed attack rate expressed in percentage

    Time frame: through study completion, an average of 3 months

Secondary outcomes

  1. Safety: Incidence of Related virus-emergent adverse events

    Safety: Incidence of Related virus-emergent adverse events

    Time frame: through study completion, an average of 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04372719
Lead sponsor
SGS Life Sciences, a division of SGS Belgium NV
Responsible party
Sponsor
First posted
May 4, 2020
Start date
Nov 2, 2016
Primary completion
Dec 28, 2016
Completion
Dec 28, 2016
Last update
May 4, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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