Swine-Origin Influenza A H1N1 Virus
Conditions
Keywords
Influenza A, H1N1 subtype, Vaccine, Adjuvant, Cell culture
Brief summary
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
Interventions
BIOLOGICALCell-derived A/H1N1 influenza HA vaccine
Single group vaccinated
Sponsors
Novartis Vaccines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate clinical symptoms according to the subject background after vaccination | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| The kinds, degrees, durations and onset ratios of adverse events | 28 days |
Countries
Japan
Outcome results
None listed