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Influenza (Pandemic)Phase 1/2NCT02078674

A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

A Phase 1/2 study testing Monovalent Avian Influenza VLP (H7N9) and Matrix-M1™ adjuvant in people with Influenza (Pandemic), run by Novavax at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Influenza (Pandemic)
What is being tested?
Monovalent Avian Influenza VLP (H7N9) and Matrix-M1™ adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
610 participants
Where
5 sitesUnited States
Study dates
Mar 2014to Jul 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male or female, 18 to 64 years of age,
  • Willing and able to give informed consent prior to study enrollment,
  • Able to comply with study requirements, and
  • Women of child-bearing potential must have a negative urine pregnancy test prior to each vaccination, and will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or ≥50 years of age and without menses for ≥1 year are exempt from urine pregnancy testing.

Who cannot join

  • Subjects will be excluded if they meet any of the following criteria:
  • Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
  • Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the Investigator.
  • Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
  • Note that illnesses or conditions may be exclusionary, even if otherwise stable and clinically minor, due to therapies used to treat them (see exclusion criteria 3, 5, 8, 9).
  • Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase, total bilirubin, blood urea nitrogen, or creatinine levels.
Show all 18Show fewer
  • Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 2 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
  • Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  • History of a serious reaction to prior influenza vaccination.
  • History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  • Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
  • Known disturbance of coagulation.
  • Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  • Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Miami Research Associates

    Miami, Florida, 33143

  • Coastal Carolina Research

    Mt. Pleasant, South Carolina, 29464

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase I/II Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/13 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Matrix-M1™

This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years.

Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

Being tested
Monovalent Avian Influenza VLP (H7N9), Matrix-M1™ adjuvant, Placebo
Keywords
H7N9
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monovalent Avian Influenza VLP (H7N9)Biological

  • Matrix-M1™ adjuvantBiological

  • PlaceboBiological

Study groups in NCT02078674
Study groupRoleWhat they receive
Group AExperimentalPlacebo
Receives: Biological: Placebo
Group BExperimentalHigh dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9)
Group CExperimentalHigh dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant
Group DExperimentalIntermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant
Group EExperimentalLow dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant
Group FExperimentalHigh dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant
Group GExperimentalIntermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant
Group HExperimentalLow dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Safety

    Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection.

    In addition, MAEs, SAEs, and SNMCs will be collected for one year.

    Measured: Day 0 to Day 384

  2. Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus.

    Geometric mean titer (GMT) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)

    Measured: Day 0 to Day 384

Secondary outcomes (1)

  1. Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.

    Measured: Day 0 to Day 384

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02078674
Sponsor's protocol ID
FLU-MI7A-201
Status last verified
Sep 2016
First submitted
3 Mar 2014
Last updated
23 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Monovalent Avian Influenza VLP (H7N9) and Matrix-M1™ adjuvant in people with Influenza (Pandemic), run by Novavax at 5 sites in United States.

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 4 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of Safety (time frame: Day 0 to Day 384). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078674.

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 Sep 2016.

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