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NCT00479648 Clinical Trial

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

Influenza Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00479648
Other study ID # CSLCT-IIV-06-27
Secondary ID
Status Completed
Phase Phase 2
First received May 25, 2007
Last updated July 17, 2016
Start date May 2007
Est. completion date August 2007

Study information
Verified date November 2008
Source Seqirus
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 612
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Biological:
• CSL412

• Inactivated trivalent influenza vaccine

Locations
Country Name City State
United Kingdom Chiltern International Slough

Sponsors (1)
Lead Sponsor Collaborator
Seqirus

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary seroprotection rate, HI titre & seroconversion/ significant increase Yes
Primary grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis Yes
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