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

Sponsor:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00940108

Purpose

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

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:	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, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 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 each 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:	369
Study Start Date:	July 2009
Study Completion Date:	April 2010
Primary Completion Date:	October 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:	6 Months to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

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: NCT00940108

Locations

Australia, New South Wales

Westmead, New South Wales, Australia, 2145
Australia, Queensland

Brisbane, Queensland, Australia, 4006
Australia, South Australia

North Adelaide, South Australia, Australia, 5006
Australia, Victoria

Carlton, Victoria, Australia, 3010
Australia, Western Australia

Subiaco, Western Australia, Australia, 6027

Sponsors and Collaborators

CSL Limited

More Information

Publications:

Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. Epub 2009 Dec 21.

Responsible Party:	Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier:	NCT00940108 History of Changes
Other Study ID Numbers:	CSLCT-CAL-09-60
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 February 09, 2012