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Completed

NCT Number: NCT01393951

A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.

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Key information

Conditions

Healthy Immunogenicity of ASP7374

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kyushu, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg
  • BMI: ≥17.6, <26.4
  • Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion criteria

  • Scheduled to receive another vaccine during study participation period
  • Received influenza vaccine within 180 days prior to the study
  • Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of 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
  • Past 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)
  • Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Treatment and study plan

ASP7374

Biological

subcutaneous and intramuscular

Primary outcomes

  1. Immunogenicity: HI antibody titer

    Time frame: Day 29

  2. Safety: Incidence of Adverse events, vital signs and laboratory tests

    Time frame: 28 days post-vaccination

Sponsors and collaborators

Lead sponsor

UMN Pharma Inc.

Industry

Registry information

Official study title

Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2011
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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