Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
NCT01100294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2012-05-21
Summary
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
Conditions
Interventions
- BIOLOGICAL
-
Vaccination with FLUVAL P
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.
Sponsors & Collaborators
-
Fluart Innovative Vaccine Ltd, Hungary
lead INDUSTRY
Principal Investigators
-
Anna Ősi, Dr. · Omninvest Ltd.
-
Éva Szabó, MD · "Csolnoky Ferenc" Veszprém County Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Months
- Max Age
- 36 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2010-04-30
- Completion
- 2010-05-31
Countries
- Hungary
Study Locations
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