Status:
COMPLETED
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
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 pop...
Eligibility Criteria
Inclusion
- 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
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1474 Patients enrolled
Trial Details
Trial ID
NCT00959049
Start Date
September 1 2009
End Date
May 1 2010
Last Update
May 16 2017
Active Locations (23)
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1
Chandler, Arizona, United States, 85224
2
Harrisburg, Arkansas, United States, 72432
3
Jonesboro, Arkansas, United States, 72401
4
Little Rock, Arkansas, United States, 72205