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

NCT00562484 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7500

Last updated 2017-11-21

Study results available
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Summary

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.

Conditions

  • Influenza

Interventions

BIOLOGICAL

CSL Limited Influenza Vaccine

A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Director Vaccines · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-11-30
Completion
2010-01-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562484 on ClinicalTrials.gov