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

Novartis

Status: Completed

Conditions: Swine-Origin Influenza A H1N1 Virus

Treatments: Biological: Cell-derived A/H1N1 influenza HA vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT01098786

V110_11

Details and patient eligibility

About

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

Enrollment: 556 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

556 participants in 1 patient group

Healthy

Treatment:

Biological: Cell-derived A/H1N1 influenza HA vaccine