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
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.
1 other identifier
interventional
1,474
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 29, 2011
CompletedMay 16, 2017
April 1, 2017
3 months
August 12, 2009
July 3, 2011
April 16, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Geometric Mean Titer 30 Days After the Last Study Vaccination
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.
30 days after the last study vaccination
Secondary Outcomes (9)
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
7 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
30 days after each vaccination
New Onset of Chronic Illnesses (NOCIs)
6 months after last study vaccination
- +4 more secondary outcomes
Study Arms (6)
Afluria Cohort A
EXPERIMENTALAge 6 months to \< 3 years
Afluria Cohort B
EXPERIMENTALAge 3 to \< 9 years
Afluria Cohort C
EXPERIMENTALAge 9 to \< 18 years
Fluzone Cohort A
ACTIVE COMPARATORAge 6 months to \< 3 years
Fluzone Cohort B
ACTIVE COMPARATORAge 3 to \< 9 years
Fluzone Cohort C
ACTIVE COMPARATORAge 9 to \< 18 years
Interventions
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (23)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Harrisburg, Arkansas, 72432, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Mountain Home, Arkansas, 72653, United States
Unknown Facility
Melbourne, Florida, 32935, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Binghamton, New York, 13901, United States
Unknown Facility
Elmira, New York, 14901, United States
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Cincinnati, Ohio, 45229, United States
Unknown Facility
Warr Acres, Oklahoma, 73132, United States
UPMC / Community Medicine Inc
Greenville, Pennsylvania, 16125, United States
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, 15650, United States
Pediatric Alliance Greentree Division
Pittsburgh, Pennsylvania, 15220, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
South Jordan, Utah, 84095, United States
Unknown Facility
Burke, Virginia, 22015, United States
Unknown Facility
Vienna, Virginia, 22180, United States
Related Publications (1)
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.
PMID: 25454878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Program Director
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Director Vaccines
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 14, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
May 16, 2017
Results First Posted
July 29, 2011
Record last verified: 2017-04