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

Seqirus

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Inactivated trivalent influenza vaccine; Biological: CSL412

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479648

CSLCT-IIV-06-27

Details and patient eligibility

About

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.

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

612 participants in 4 patient groups

1

Active Comparator group

Description:

Inactivated trivalent influenza vaccine

Treatment:

Biological: Inactivated trivalent influenza vaccine

2

Experimental group

Description:

CSL412 formulation

Treatment:

Biological: CSL412

3

Experimental group

Description:

CSL412 formulation

Treatment:

Biological: CSL412

4

Experimental group

Description:

CSL412 formulation

Treatment:

Biological: CSL412