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

Completed

• Conditions: Swine-Origin Influenza A H1N1 Virus
• Interventions: Biological: Cell-derived A/H1N1 influenza HA vaccine

• Registration Number: NCT01098786
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-04-02
• Study First Posted: 2010-04-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

1. Healthy Japanese

Exclusion Criteria

1. The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.

2. 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.

3. The person shows obvious fever.

4. The person obviously suffers from serious acute disease.

5. The person has obviously shown anaphylaxis due to an ingredient of this vaccine.

6. The person is otherwise in an inappropriate state to receive preventive vaccination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Cell-derived A/H1N1 influenza HA vaccine	-

Primary Outcome Measures

Name	Time	Method
Evaluate clinical symptoms according to the subject background after vaccination	28 days

Secondary Outcome Measures

Name	Time	Method
The kinds, degrees, durations and onset ratios of adverse events	28 days

Trial Locations

Locations (1)

National Hospital Organization Kumamoto Medical Center; 🇯🇵 Chuo-ku, Kumamoto, Japan