InfluenzaPhase 3NCT02366962
A Study to Assess the Safety of ASP7374 in Adult Subjects Aged 20 or Older
A Phase 3 study testing ASP7374 in people with Influenza and Vaccine, run by UMN Pharma Inc. at 1 site in Japan.
Trial summary
The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- What is being tested?
- ASP7374
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2015to Apr 2015
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically stable, as judged on the basis of history and concurrent diseases
- Subject understands procedure of the protocol and is willing to comply with the protocol.
Who cannot join
- Scheduled to receive another vaccine during the study.
- Received influenza HA vaccine within 180 days prior to screening.
- Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
- Diagnosis of immune deficit in the past has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
- Received one of the following medications or treatment prior to vaccination with the study vaccine:
- 1. Within 28 days prior to vaccination with the study vaccine
Show all 29Show fewer
- Interferon formulation
- Drugs which affect the immune system (e.g., immunosuppressants)
- Systemic corticosteroids and inhaled corticosteroids
- G-CSF and M-CSF
- 2. Within 84 days prior to vaccination with the study vaccine
- Human immunoglobulin products
- Blood products
- Blood transfusion
- 3. Within 180 days prior to vaccination with the study vaccine
- High-dose human immunoglobulin products (≥200 mg/kg)
- History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
- History of seizures (exclude a pyrexial attack in childhood)
- History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
- Body temperature of ≥37.5°C on Day 1 (before vaccination)
- Moderate to severe acute or febrile illness (≥37.5°C) within 7 days prior to vaccination
- Concurrent hepatic disease (exclude fatty liver, hepatic cyst, biliary stone and gallbladder poly, which have laboratory findings only, no clinical symptoms, and not necessary to treat), or AST (GOT) and/or ALT (GPT) of >100 IU/L at screening on Day 1
- Concurrent renal disease (exclude rental cyst and calculus kidney which have laboratory findings only, no clinical symptoms, and not necessary to treat), or creatinine of > 1.5 mg/dL at screening
- Concurrent respiratory disease, hematologic disease, or developmental disorders
- Concurrent or previous heart disease
- Concurrent or previous cerebrovascular disorder
- Concurrent malignancy or diagnosis or treatment of malignancy within 5 years before screening
- Diagnosis of mental disorder including schizophrenia, bipolar disorder, or major depressive disorder or cognitive impairment, or received medications for cognitive impairment
- Concurrent disease interfering with the evaluation of local and systemic reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older
The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older
- Being tested
- ASP7374
- Keywords
- Influenza, Vaccine, ASP7374
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP7374Biological
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| ASP7374 group | Experimental | Not described Receives: Biological: ASP7374 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by adverse events
Measured: Up to Day 29
Secondary outcomes (1)
Local and systemic reactions associated with the vaccination
Measured: Up 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 posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMN Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366962
- Sponsor's protocol ID
- 7374-CL-0107
- Status last verified
- Sep 2017
- First submitted
- 12 Feb 2015
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older
- ClinicalTrials.gov ID
- NCT02366962
- Acronym / sponsor ID
- 7374-CL-0107
- Keywords
- Influenza, Vaccine, ASP7374
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- UMN Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP7374 group | Experimental | Biological: ASP7374 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medically stable, as judged on the basis of history and concurrent diseases
- Subject understands procedure of the protocol and is willing to comply with the protocol.
Key exclusion criteria (29 listed)
- Scheduled to receive another vaccine during the study.
- Received influenza HA vaccine within 180 days prior to screening.
- Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
- Diagnosis of immune deficit in the past has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
- Received one of the following medications or treatment prior to vaccination with the study vaccine:
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 |
|---|---|---|
| ASP7374subcutaneous | Biological | ASP7374 group |
Primary outcome
Safety assessed by adverse events
Time frame: Up to Day 29
1 secondary outcome
Local and systemic reactions associated with the vaccination
Time frame: Up to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASP7374 in people with Influenza and Vaccine, run by UMN Pharma Inc. at 1 site in Japan.
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 2 inclusion and 29 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 29 Sep 2017. 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 Japan. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety assessed by adverse events (time frame: Up to Day 29). 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 29 Sep 2017.