Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
5-8 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT02212106
Start Date
September 1 2014
End Date
December 1 2014
Last Update
October 16 2015
Active Locations (11)
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1
Site 286
Los Angeles, California, United States, 90036
2
Site 289
Boise, Idaho, United States, 83642
3
Site 287
St Louis, Missouri, United States, 63141
4
Site 285
Binghamton, New York, United States, 13901