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A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

NCT02214225 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3484

Last updated 2017-03-13

Study results available
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Summary

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine (QIV)

One 0.5 mL intramuscular dose into the deltoid muscle

BIOLOGICAL

Trivalent Influenza Vaccine (TIV-1)

One 0.5 mL intramuscular dose into the deltoid muscle.

BIOLOGICAL

Trivalent Influenza Vaccine (TIV-2)

One 0.5 mL intramuscular dose into the deltoid muscle.

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • bioCSL Pty Ltd Clinical Program Director · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-11-30
Completion
2015-04-30

Countries

  • United States

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 NCT02214225 on ClinicalTrials.gov