A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

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Status and phase

Completed
Phase 4

Conditions

Influenza

Treatments

Biological: CSL Limited Influenza Vaccine
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562484
CSLCT-USF-06-28

Details and patient eligibility

About

This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.

Enrollment

7,500 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
  • Non pregnant/ non lactating females

Exclusion criteria

  • Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
  • Vaccination against influenza in the previous 6 months
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
  • Known history of Guillain-Barré Syndrome;
  • Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
  • History of neurological disorders or seizures
  • Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
  • Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
  • Administration of immunoglobulins and/or any blood products;
  • Participation in a clinical trial or use of an investigational compound;
  • Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
  • Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.

Trial design

7,500 participants in 2 patient groups

1
Experimental group
Treatment:
Biological: CSL Limited Influenza Vaccine
2
Other group
Treatment:
Biological: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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