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

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ClinicalTrials.gov Identifier: NCT00479648
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : July 19, 2016
Sponsor:
Information provided by:
Seqirus

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: CSL412 Biological: Inactivated trivalent influenza vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 612 participants
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)
Study Start Date : May 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

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

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