A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years.
- Conditions
- Influenza, humanTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-000175-27-Outside-EU/EEA
- Lead Sponsor
- bioCSL Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 400
* Males or females aged 5 to less than 9 years at the time of first study vaccination. * The subject’s parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements. * In good health, as determined by medical history and a targeted physical examination (if warranted).
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
* Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines. * Clinical signs of significant active infection or an elevated oral temperature at study entry. * A clinically significant medical or psychiatric condition. * A history of seizures or febrile convulsions or Guillain-Barré syndrome. * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation. * Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry. * Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine. * Currently receiving treatment with warfarin or other anticoagulants.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method