Back to resultsA 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
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CSL's Influenza Virus Vaccine (Afluria)
Influenza Virus Vaccine (Fluzone)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
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.
Sites / Locations
- Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
- UPMC / Community Medicine Inc
- Pediatric Associates of Latrobe
- Pediatric Alliance Greentree Division
- South Hills Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Afluria Cohort A
Afluria Cohort B
Afluria Cohort C
Fluzone Cohort A
Fluzone Cohort B
Fluzone Cohort C
Arm Description
Age 6 months to < 3 years
Age 3 to < 9 years
Age 9 to < 18 years
Age 6 months to < 3 years
Age 3 to < 9 years
Age 9 to < 18 years
Outcomes
Primary Outcome Measures
Geometric Mean Titer 30 Days After the Last Study Vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Secondary Outcome Measures
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Events
New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Serious Adverse Events (SAEs)
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Duration of Local and Systemic Solicited Symptoms, Cohort B
Duration of Local and Systemic Solicited Symptoms, Cohort C
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959049
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1474 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Afluria Cohort A
Arm Type
Experimental
Arm Description
Age 6 months to < 3 years
Arm Title
Afluria Cohort B
Arm Type
Experimental
Arm Description
Age 3 to < 9 years
Arm Title
Afluria Cohort C
Arm Type
Experimental
Arm Description
Age 9 to < 18 years
Arm Title
Fluzone Cohort A
Arm Type
Active Comparator
Arm Description
Age 6 months to < 3 years
Arm Title
Fluzone Cohort B
Arm Type
Active Comparator
Arm Description
Age 3 to < 9 years
Arm Title
Fluzone Cohort C
Arm Type
Active Comparator
Arm Description
Age 9 to < 18 years
Intervention Type
Biological
Intervention Name(s)
CSL's Influenza Virus Vaccine (Afluria)
Intervention Description
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine (Fluzone)
Intervention Description
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Primary Outcome Measure Information:
Title
Geometric Mean Titer 30 Days After the Last Study Vaccination
Time Frame
30 days after the last study vaccination
Title
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Description
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Time Frame
30 days after the last study vaccination
Secondary Outcome Measure Information:
Title
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time Frame
7 days after each vaccination
Title
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Time Frame
7 days after each vaccination
Title
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Time Frame
7 days after vaccination
Title
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Description
UAE stands for Unsolicited Adverse Events
Time Frame
30 days after each vaccination
Title
New Onset of Chronic Illnesses (NOCIs)
Description
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Time Frame
6 months after last study vaccination
Title
Serious Adverse Events (SAEs)
Time Frame
6 months after last study vaccination
Title
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time Frame
7 days after each vaccination
Title
Duration of Local and Systemic Solicited Symptoms, Cohort B
Time Frame
7 days after each vaccination
Title
Duration of Local and Systemic Solicited Symptoms, Cohort C
Time Frame
7 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director Vaccines
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Mountain Home
State/Province
Arkansas
ZIP/Postal Code
72653
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
City
Elmira
State/Province
New York
ZIP/Postal Code
14901
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Warr Acres
State/Province
Oklahoma
ZIP/Postal Code
73132
Country
United States
Facility Name
UPMC / Community Medicine Inc
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
Pediatric Associates of Latrobe
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
Pediatric Alliance Greentree Division
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
South Hills Pediatrics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25454878
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.
Results Reference
derived
Learn more about this trial
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
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