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A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00938639
First received: July 13, 2009
Last updated: May 22, 2010
Last verified: May 2010
History of Changes
  Purpose

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.


Condition Intervention Phase
Influenza Caused by the Novel Influenza A (H1N1) Virus
 Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 21 days after the first vaccination and again 21 days after the second vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency, duration and intensity of solicited adverse events [ Time Frame: During the 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Frequency, duration, and intensity of unsolicited adverse events [ Time Frame: During the 21 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Incidence of Serious Adverse Events, Adverse Events of Special Interest (AESI's) and new onset of Chronic Illnesses [ Time Frame: From the time of providing informed consent up to 180 days after the last vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mcg HA dose group
15 mcg of HA antigen per dose
 Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
Experimental: 30 mcg HA dose group
30 mcg of HA antigen per dose
 Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female aged >= 18 to < 65 years at the time of providing informed consent.

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938639

Locations
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
CSL Limited
  More Information

Publications:

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00938639     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-59
Study First Received: July 13, 2009
Last Updated: May 22, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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 June 18, 2013