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A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 Months to less than 18 Years.

Trial Profile

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged greater than or equal to 6 Months to less than 18 Years.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 May 2019

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At a glance

  • Drugs Influenza virus vaccine (Afluria) (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions
  • Sponsors CSL; Seqirus
  • Most Recent Events

    • 29 Mar 2019 Results comparing the rates of fever observed in children (aged 6 months to <18 years) in the three studies of S-IIV3/S-IIV4 (NCT02212106, NCT02545543 and NCT02914275) prepared using the modified manufacturing process and 3 historical formulation studies: two single-arm studies (FLU-04-05 ; USF-06-29 and one blinded, comparator-controlled study USF-07-36) published in the Vaccine
    • 24 May 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 17 Sep 2009 Actual patient number (1992) added as reported by ClinicalTrials.gov.
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