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Clinical Trials/EUCTR2015-004820-69-Outside-EU/EEA
EUCTR2015-004820-69-Outside-EU/EEAActive, not recruitingPhase 1

An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

CSL Limited0 sites300 target enrollmentStarted: August 5, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months 2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
  • •3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and,
  • •4. Be born after a normal gestation period (between 36 and 42 weeks).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 300
  • •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

Exclusion Criteria

  • •1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
  • •2. Previous influenza vaccination;
  • •3. Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
  • •4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
  • •5. Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows: •Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).
  • •6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
  • •7. Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
  • •8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
  • •9. Have a known history of Guillain-Barré Syndrome;
  • •10. Have a major congenital defect or serious illness and
  • •11. Have a history of neurologic disorders or seizures.

Investigators

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