A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:5 - 8
Updated:4/21/2016
Start Date:September 2014
End Date:December 2014

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A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent
Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
children aged 5 years to less than 9 years. Comparison will be made to a licensed
Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
2014/2015 influenza season in the US.


Inclusion Criteria:

- Males or females aged 5 to less than 9 years at the time of first study vaccination.

- The subject's parent or guardian to provide written informed consent and be willing
and able to adhere to all protocol requirements.

- In good health, as determined by medical history and a targeted physical examination
(if warranted).

Exclusion Criteria:

- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to
eggs or any components of the study vaccines.

- Clinical signs of significant active infection or an elevated oral temperature at
study entry.

- A clinically significant medical or psychiatric condition.

- A history of seizures or febrile convulsions or Guillain-Barré syndrome.

- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
preceding study entry.

- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning
to be vaccinated with another licensed vaccine before the study exit evaluation.

- Currently receiving systemic glucocorticoid therapy (excluding intra-articular,
topical or inhaled preparations) or have received such therapy within the 3 months
preceding study entry.

- Currently receiving immunoglobulins and/or any blood products or have received such
treatment within the 3 months preceding the administration of the study vaccine.

- Currently receiving treatment with warfarin or other anticoagulants.
We found this trial at
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Boise, ID
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Charleston, South Carolina 29412
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Saint Louis, MO
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San Angelo, TX
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Winston-Salem, NC
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