Clinical trial NCT02212106: A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 402
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


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.

Primary outcomes:
measure: The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
timeFrame: 7 days after each administration of vaccine.
Secondary outcomes:
measure: The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
measure: The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
measure: The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
measure: The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
measure: The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
measure: The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
timeFrame: 7 days after each administration of vaccine.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site 286
state: California
city: Boise
country: United States
facility: Site 289
state: Idaho
city: Saint Louis
country: United States
facility: Site 287
state: Missouri
city: Binghamton
country: United States
facility: Site 285
state: New York
city: Durham
country: United States
facility: Site 290
state: North Carolina
city: Raleigh
country: United States
facility: Site 281
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 280
state: North Carolina
city: Charleston
country: United States
facility: Site 284
state: South Carolina
city: Austin
country: United States
facility: Site 283
state: Texas
city: Fort Worth
country: United States
facility: Site 282
state: Texas
city: San Angelo
country: United States
facility: Site 288
state: Texas
Study officials:
affiliation: Seqirus
name: bioCSL Pty Ltd Clinical Program Director
role: STUDY_DIRECTOR
References: