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

This study has been completed.

Sponsor:

Information provided by:

CSL Limited

ClinicalTrials.gov Identifier:

NCT00940108

First received: July 13, 2009

Last updated: May 22, 2010

Last verified: May 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2009
Last Updated Date	May 22, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 14, 2009)	Immunogenicity [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00940108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 14, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Influenza Caused by the Novel Influenza A (H1N1) Virus
Intervention ^ICMJE	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 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
Study Arm (s)	Experimental: 15 mcg HA dose group 15 mcg of HA antigen per dose Intervention: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) Experimental: 30 mcg HA dose group 30 mcg of HA antigen per dose Intervention: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	369
Completion Date	April 2010
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Months to 8 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00940108
Other Study ID Numbers ^ICMJE	CSLCT-CAL-09-60
Has Data Monitoring Committee	Yes
Responsible Party	Dr Russell Basser, CSL Limited
Study Sponsor ^ICMJE	CSL Limited
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CSL Limited
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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