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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479648
First Posted: May 28, 2007
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seqirus
  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: Quadruple (Participant, Care Provider, 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 Seqirus:

Primary Outcome Measures:
  • seroprotection rate, HI titre & seroconversion/ significant increase
  • grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479648


Locations
United Kingdom
Chiltern International
Slough, United Kingdom
Sponsors and Collaborators
Seqirus
Investigators
Principal Investigator: Elizabeth Hancox, Dr Chiltern International
  More Information

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00479648     History of Changes
Other Study ID Numbers: CSLCT-IIV-06-27
First Submitted: May 25, 2007
First Posted: May 28, 2007
Last Update Posted: July 19, 2016
Last Verified: November 2008

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs