Trial Profile
A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 03 May 2019
Price :
$35
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At a glance
- Drugs Influenza virus vaccine (Afluria) (Primary) ; Influenza virus vaccine
- Indications Influenza virus infections
- Focus Pharmacodynamics
- Sponsors CSL; Seqirus
- 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 Planned number of patients changed from 1476 to 1474 as reported by ClinicalTrials.gov record.
- 24 May 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.