Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years
NCT00825162 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1992
Last updated 2018-05-23
Summary
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged \>= 6 Months to \< 18 Years
Conditions
Interventions
- BIOLOGICAL
-
CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.25mL)
- BIOLOGICAL
-
CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.5mL)
- BIOLOGICAL
-
CSL Limited Influenza Virus Vaccine
Single vaccination regimen (0.5mL)
Sponsors & Collaborators
-
Seqirus
lead INDUSTRY
Principal Investigators
-
Stephen Lambert, Dr · Royal Children's Hospital, Brisbane, Herston, QLD, Australia
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- Australia
Study Locations
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