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OpenTrials
Completed

NCT Number: NCT01961947

Study of ASP7374, Cell-culture-derived Influenza Vaccine

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and <65 years.

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanto, Japan

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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.
  • 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 (including chicken, poultry, foodstuffs derived from chicken, et al.) 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

subcutaneous

approved egg-derived TIV

Biological

subcutaneous

Other names: Influenza HA vaccine "SEIKEN"

Primary outcomes

  1. seroconversion rate of hemagglutination inhibition (HI) antibody titer

    Time frame: Day 29

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

  2. geometric mean titer (GMT) of HI antibody titer

    Time frame: Day 29

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

Secondary outcomes

  1. seroprotection rate of HI antibody titer

    Time frame: Day 29

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

  2. GMT ratio of HI antibody titer (Day 29/Day 1)

    Time frame: Day1 and Day 29

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

  3. seroconversion rate of neutralizing antibody titer

    Time frame: Day 29

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

  4. seroprotection of neutralizing antibody titer

    Time frame: Day 29

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

  5. GMT of neutralizing antibody titer

    Time frame: Day 29

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

  6. GMT ratio of neutralizing antibody titer (Day 29/Day 1)

    Time frame: Day 1 and Day 29

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

  7. 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 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 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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