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

Completed · Phase 4

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT02212106

Run by

Seqirus

People needed

402

Starts

2014-09-01

Expected to finish

2014-12-01

Last updated by the study team

2015-10-16

Who can join

Age: 5 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Site 286 — Los Angeles, California, United States
• Site 289 — Boise, Idaho, United States
• Site 287 — St Louis, Missouri, United States
• Site 285 — Binghamton, New York, United States
• Site 290 — Durham, North Carolina, United States
• Site 281 — Raleigh, North Carolina, United States
• Site 280 — Winston-Salem, North Carolina, United States
• Site 284 — Charleston, South Carolina, United States
• Site 283 — Austin, Texas, United States
• Site 282 — Fort Worth, Texas, United States
• Site 288 — San Angelo, Texas, United States

Full record on ClinicalTrials.gov

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