CompletedNot Applicable

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

Japan556 participantsStarted 2010-02

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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 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.

Evaluate clinical symptoms according to the subject background after vaccination

Timeframe: 28 days

NCT IDNCT01098786

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-11