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

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00938639

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Fluvirin Influenza Vaccines

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 ]

Estimated Enrollment:	240
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 mcg HA dose group: Experimental 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
30 mcg HA dose group: Experimental 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

No publications provided

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-CAL-09-59
Study First Received:	July 13, 2009
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00938639 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
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 September 11, 2009