Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine

Sponsor

Novartis Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT01098786

Collaborator

(none)

556

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Swine-Origin Influenza A H1N1 Virus	Biological: Cell-derived A/H1N1 influenza HA vaccine

Study Design

Study Type:

Observational

Actual Enrollment :

556 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Healthy	Biological: Cell-derived A/H1N1 influenza HA vaccine Single group vaccinated

Arm

Intervention/Treatment

Healthy

Biological: Cell-derived A/H1N1 influenza HA vaccine

Single group vaccinated

Outcome Measures

Primary Outcome Measures

Evaluate clinical symptoms according to the subject background after vaccination [28 days]

Secondary Outcome Measures

The kinds, degrees, durations and onset ratios of adverse events [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy Japanese

Exclusion Criteria:

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.