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

A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479648

Enrollment

612

Registered

2007-05-28

Start date

2007-05-31

Completion date

2007-08-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

BIOLOGICALCSL412

BIOLOGICALInactivated trivalent influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026