Influenza, Human

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

NCT02212106 | PHASE 4 | INTERVENTIONAL

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.

11 Sites

402 Participants

Recruiting

5 Years to 8 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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Find closest sites:

SUBMIT

Site

Los Angeles,California,United States,90036

Site

Boise,Idaho,United States,83642

Site

Saint Louis,Missouri,United States,63141

Site

Binghamton,New York,United States,13901

Site

Durham,North Carolina,United States,27704

Site

Raleigh,North Carolina,United States,27609

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Winston-Salem,North Carolina,United States,27103

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Charleston,South Carolina,United States,29403

Site

Austin,Texas,United States,78705

Site

Fort Worth,Texas,United States,76135

Site

San Angelo,Texas,United States,76904

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov