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

Seqirus612 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

612

Conditions

Influenza

Interventions

CSL412BIOLOGICAL

Inactivated trivalent influenza vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chiltern International

Slough, United Kingdom

Outcomes

Primary Outcomes

seroprotection rate, HI titre & seroconversion/ significant increase

grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis

Data from ClinicalTrials.gov

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