NCT01098786

Brief Summary

This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 31, 2010

Last Update Submit

March 13, 2017

Conditions

Swine-Origin Influenza A H1N1 Virus

Keywords

Influenza AH1N1 subtypeVaccineAdjuvantCell culture

Outcome Measures

Primary Outcomes (1)

  • Evaluate clinical symptoms according to the subject background after vaccination

    28 days

Secondary Outcomes (1)

  • The kinds, degrees, durations and onset ratios of adverse events

    28 days

Study Arms (1)

Healthy

Biological: Cell-derived A/H1N1 influenza HA vaccine

Interventions

Cell-derived A/H1N1 influenza HA vaccineBIOLOGICAL

Single group vaccinated

Healthy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • \. Healthy Japanese

You may not qualify if:

  • The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
  • The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.
  • The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
  • The person shows obvious fever.
  • The person obviously suffers from serious acute disease.
  • The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
  • The person is otherwise in an inappropriate state to receive preventive vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital Organization Kumamoto Medical Center

Chuo-ku, Kumamoto, 860-0008, Japan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 5, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

JP(1)