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

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00479648
First received: May 25, 2007
Last updated: November 6, 2008
Last verified: November 2008
  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 2

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

Resource links provided by NLM:


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
Active Comparator: 1
Inactivated trivalent influenza vaccine
Biological: Inactivated trivalent influenza vaccine
Experimental: 2
CSL412 formulation
Biological: CSL412
Experimental: 3
CSL412 formulation
Biological: CSL412
Experimental: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014