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OpenTrials
Completed

NCT Number: NCT01098786

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

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

Completed

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Key information

Conditions

Swine-Origin Influenza A H1N1 Virus

Sex eligibility

All sexes

Study type

Observational

Primary location

National Hospital Organization Kumamoto Medical Center

Chuo-ku, Kumamoto, 860-0008, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Japanese

Exclusion criteria

  • 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 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.

  • 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.

Treatment and study plan

Cell-derived A/H1N1 influenza HA vaccine

Biological

Single group vaccinated

Primary outcomes

  1. Evaluate clinical symptoms according to the subject background after vaccination

    Time frame: 28 days

Secondary outcomes

  1. The kinds, degrees, durations and onset ratios of adverse events

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2010
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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