A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
NCT00700193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298
Last updated 2016-07-19
Summary
The purpose of this study is to determine the Safety, Tolerability \& Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.
Conditions
Interventions
- BIOLOGICAL
-
Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
- BIOLOGICAL
-
Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
Sponsors & Collaborators
-
Seqirus
lead INDUSTRY
Principal Investigators
-
Terry M Nolan, Prof · Murdoch Childrens Research Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2006-06-30
Countries
- Australia
Study Locations
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