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

Completed · Phase 3

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00959049

Run by

Seqirus

People needed

1474

Starts

2009-09-01

Expected to finish

2010-05-01

Last updated by the study team

2017-05-16

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Harrisburg, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Mountain Home, Arkansas, United States
• Study site — Melbourne, Florida, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Omaha, Nebraska, United States
• Study site — Binghamton, New York, United States
• Study site — Elmira, New York, United States
• Cincinnati Children's Hospital Medical Center- Division of Infectious Disease — Cincinnati, Ohio, United States
• Study site — Warr Acres, Oklahoma, United States
• UPMC / Community Medicine Inc — Greenville, Pennsylvania, United States
• Pediatric Associates of Latrobe — Latrobe, Pennsylvania, United States
• Pediatric Alliance Greentree Division — Pittsburgh, Pennsylvania, United States
• South Hills Pediatrics — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — South Jordan, Utah, United States
• Study site — Burke, Virginia, United States
• Study site — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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