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

Swine-Origin Influenza A H1N1 Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098786
• Other study ID #: V110_11
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: March 13, 2017
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Swine-Origin Influenza A H1N1 Virus

Intervention

Biological:
• Cell-derived A/H1N1 influenza HA vaccine
Single group vaccinated

Locations

Country	Name	City	State
Japan	National Hospital Organization Kumamoto Medical Center	Chuo-ku	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate clinical symptoms according to the subject background after vaccination		28 days
Secondary	The kinds, degrees, durations and onset ratios of adverse events		28 days