NCT01961947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

October 10, 2013

Last Update Submit

September 27, 2017

Conditions

InfluenzaVaccine

Keywords

ASP7374Approved egg-derived vaccinePrevention of seasonal influenza

Outcome Measures

Primary Outcomes (2)

  • seroconversion rate of hemagglutination inhibition (HI) antibody titer

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

    Day 29

  • geometric mean titer (GMT) of HI antibody titer

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

    Day 29

Secondary Outcomes (7)

  • seroprotection rate of HI antibody titer

    Day 29

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

    Day1 and Day 29

  • seroconversion rate of neutralizing antibody titer

    Day 29

  • seroprotection of neutralizing antibody titer

    Day 29

  • GMT of neutralizing antibody titer

    Day 29

  • +2 more secondary outcomes

Study Arms (2)

ASP7374 group

EXPERIMENTAL
Biological: ASP7374

TIV group

ACTIVE COMPARATOR
Biological: approved egg-derived TIV

Interventions

ASP7374BIOLOGICAL

subcutaneous

ASP7374 group
approved egg-derived TIVBIOLOGICAL

subcutaneous

Also known as: Influenza HA vaccine "SEIKEN"
TIV group

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Director

    Astellas Pharma Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

JP(2)