Clinical trial NCT00959049: A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Official title: A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 1474
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female participants aged ≥ 6 calendar months to \< 18 years at the time of the first study vaccination.
* For participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks).
* Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

Primary outcomes:
measure: Geometric Mean Titer 30 Days After the Last Study Vaccination
timeFrame: 30 days after the last study vaccination
measure: Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
timeFrame: 30 days after the last study vaccination
Secondary outcomes:
measure: Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
timeFrame: 7 days after each vaccination
measure: Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
timeFrame: 7 days after each vaccination
measure: Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
timeFrame: 7 days after vaccination
measure: Frequency and Intensity of Unsolicited Adverse Events (UAEs)
timeFrame: 30 days after each vaccination
measure: New Onset of Chronic Illnesses (NOCIs)
timeFrame: 6 months after last study vaccination
measure: Serious Adverse Events (SAEs)
timeFrame: 6 months after last study vaccination
measure: Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
timeFrame: 7 days after each vaccination
measure: Duration of Local and Systemic Solicited Symptoms, Cohort B
timeFrame: 7 days after each vaccination
measure: Duration of Local and Systemic Solicited Symptoms, Cohort C
timeFrame: 7 days after vaccination
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Harrisburg
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Mountain Home
country: United States
state: Arkansas
city: Melbourne
country: United States
state: Florida
city: Bardstown
country: United States
state: Kentucky
city: Omaha
country: United States
state: Nebraska
city: Binghamton
country: United States
state: New York
city: Elmira
country: United States
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
state: Ohio
city: Warr Acres
country: United States
state: Oklahoma
city: Greenville
country: United States
facility: UPMC / Community Medicine Inc
state: Pennsylvania
city: Latrobe
country: United States
facility: Pediatric Associates of Latrobe
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance Greentree Division
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References:
citation: Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.