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OpenTrials
Completed

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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Key information

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanto, Japan

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

Biological

intramuscular

Primary outcomes

  1. hemagglutination inhibition (HI) antibody titer

    Time frame: Day 1 and Day 29

    evaluated for A/H1N1, A/H3N2, and B

Secondary outcomes

  1. neutralizing antibody titer

    Time frame: Day 1 and Day 29

    evaluated for A/H1N1, A/H3N2, and B

  2. 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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