A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants

NCT ID: NCT00479648

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Inactivated trivalent influenza vaccine

Group Type ACTIVE_COMPARATOR

Inactivated trivalent influenza vaccine

Intervention Type BIOLOGICAL

2

CSL412 formulation

Group Type EXPERIMENTAL

CSL412

Intervention Type BIOLOGICAL

3

CSL412 formulation

Group Type EXPERIMENTAL

CSL412

Intervention Type BIOLOGICAL

4

CSL412 formulation

Group Type EXPERIMENTAL

CSL412

Intervention Type BIOLOGICAL

Interventions

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CSL412

Intervention Type BIOLOGICAL

Inactivated trivalent influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 to ≤ 45 OR ≥ 60
* Ability to provide pre-vaccination venous blood sample

Exclusion Criteria

* History of clinically significant medical conditions
* Immunomodulative therapy
* Acute infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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CSL Limited

Principal Investigators

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Elizabeth Hancox, Dr

Role: PRINCIPAL_INVESTIGATOR

Chiltern International

Locations

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Chiltern International

Slough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CSLCT-IIV-06-27

Identifier Type: -

Identifier Source: org_study_id

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