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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: CSL412; Biological: Inactivated trivalent influenza vaccine

• Registration Number: NCT00479648
• Lead Sponsor: Seqirus

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-11
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	CSL412	CSL412 formulation
2	CSL412	CSL412 formulation
1	Inactivated trivalent influenza vaccine	Inactivated trivalent influenza vaccine
3	CSL412	CSL412 formulation

Primary Outcome Measures

Name	Time	Method
seroprotection rate, HI titre & seroconversion/ significant increase
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis

Trial Locations

Locations (1)

Chiltern International; 🇬🇧 Slough, United Kingdom