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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01961960
Other study ID # 7374-CL-0105
Secondary ID
Status Completed
Phase Phase 3
First received October 10, 2013
Last updated September 27, 2017
Start date October 2013
Est. completion date November 2013

Study information

Verified date September 2017
Source UMN Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 61 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ASP7374
intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary hemagglutination inhibition (HI) antibody titer evaluated for A/H1N1, A/H3N2, and B Day 1 and Day 29
Secondary neutralizing antibody titer evaluated for A/H1N1, A/H3N2, and B Day 1 and Day 29
Secondary Local and systemic reactions associated with the vaccination Day 1 through Day 8
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