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
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 4/21/2016 |
Start Date: | September 2009 |
End Date: | May 2010 |
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.
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.
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.
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.
We found this trial at
21
sites
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Cincinnati, Ohio 45229
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