A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00479648

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: CSL412 Biological: Inactivated trivalent influenza vaccine	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
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)

Further study details as provided by CSL Limited:

Primary Outcome Measures:

seroprotection rate, HI titre & seroconversion/ significant increase [ Designated as safety issue: Yes ]
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis [ Designated as safety issue: Yes ]

Enrollment:	612
Study Start Date:	May 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Inactivated trivalent influenza vaccine	Biological: Inactivated trivalent influenza vaccine
2: Experimental CSL412 formulation	Biological: CSL412
3: Experimental CSL412 formulation	Biological: CSL412
4: Experimental CSL412 formulation	Biological: CSL412

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479648

Locations

United Kingdom
Chiltern International
Slough, United Kingdom

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Elizabeth Hancox, Dr

Chiltern International

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-IIV-06-27
Study First Received:	May 25, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00479648 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009