Kanto, Japan
NCT Number: NCT01961960
A Study to Evaluate Intramuscular ASP7374
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.
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Notify MeKey information
Conditions
Age range
61 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
- Healthy or 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.
- Written informed consent has been obtained.
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: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
- 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, except for febrile seizures in childhood
Treatment and study plan
ASP7374
Biologicalintramuscular
Primary outcomes
-
hemagglutination inhibition (HI) antibody titer
Time frame: Day 1 and Day 29
evaluated for A/H1N1, A/H3N2, and B
Secondary outcomes
-
neutralizing antibody titer
Time frame: Day 1 and Day 29
evaluated for A/H1N1, A/H3N2, and B
-
Local and systemic reactions associated with the vaccination
Time frame: Day 1 through Day 8
Sponsors and collaborators
Lead sponsor
UMN Pharma Inc.
Industry
Registry information
Official study title
Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Oct 14, 2013
- 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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