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CompletedNCT01961947Updated Sep 29, 2017

Study of ASP7374, Cell-culture-derived Influenza Vaccine

A Phase 3 interventional study of ASP7374 and approved egg-derived TIV in Influenza and Vaccine, sponsored by UMN Pharma Inc.. Completed at 2 sites in Japan. Open to participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by UMN Pharma Inc. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Influenza
  • Vaccine

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Keywords

  • ASP7374
  • Approved egg-derived vaccine
  • Prevention of seasonal influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 900 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

UMN Pharma Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
900 participants (actual)

Study arms

  • Experimental
    ASP7374 group

    Biological: ASP7374

  • Active comparator
    TIV group

    Biological: approved egg-derived TIV

Interventions

  • BiologicalASP7374

    subcutaneous

  • Biologicalapproved egg-derived TIV

    subcutaneous

    Also known as: Influenza HA vaccine "SEIKEN"

06

What researchers measure

Primary outcomes

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

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

    Time frame: Day 29

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

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

    Time frame: Day 29

Secondary outcomes

  1. seroprotection rate of HI antibody titer

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

    Time frame: Day 29

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

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

    Time frame: Day1 and Day 29

  3. seroconversion rate of neutralizing antibody titer

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

    Time frame: Day 29

  4. seroprotection of neutralizing antibody titer

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

    Time frame: Day 29

  5. GMT of neutralizing antibody titer

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

    Time frame: Day 29

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

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

    Time frame: Day 1 and Day 29

  7. Local and systemic reactions associated with the vaccination

    Time frame: Day 1 through Day 8

07

Study locations

2 sites
  • Kanto, Japan
  • Kyushu, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01961947
Lead sponsor
UMN Pharma Inc.
Responsible party
Sponsor
First posted
Oct 14, 2013
Start date
Oct 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Sep 29, 2017

Study contacts

Medical Director
principal investigator · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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