Fukuoka, Japan
NCT Number: NCT02366962
A Study to Assess the Safety of 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
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Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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
Treatment and study plan
ASP7374
Biologicalsubcutaneous
Primary outcomes
-
Safety assessed by adverse events
Time frame: Up to Day 29
Secondary outcomes
-
Local and systemic reactions associated with the vaccination
Time frame: Up to Day 8
Sponsors and collaborators
Lead sponsor
UMN Pharma Inc.
Industry
Registry information
Official study title
Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Feb 19, 2015
- Registry last updated
- Sep 29, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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