A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Limited

ClinicalTrials.gov Identifier:

NCT00958243

First received: August 12, 2009

Last updated: February 10, 2012

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 12, 2009
Last Updated Date	February 10, 2012
Start Date ^ICMJE	August 2009
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 13, 2011)	Seroconversion Rate 21 Days After First Study Vaccination [ Time Frame: 21 days after the first study vaccination ] [ Designated as safety issue: No ] Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. Seroconversion Rate 21 Days After Second Study Vaccination [ Time Frame: 21 days after the second study vaccination ] [ Designated as safety issue: No ] Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination [ Time Frame: 21 days after the first study vaccination ] [ Designated as safety issue: No ] Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination [ Time Frame: 21 days after the second study vaccination ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 12, 2009)	Immunogenicity [ Time Frame: 21 days after the first vaccination and again 21 days after the second vaccination ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00958243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 25, 2011)	Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A [ Time Frame: During the 7 days after each study vaccination ] [ Designated as safety issue: Yes ] Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A [ Time Frame: During the 7 days after each study vaccination ] [ Designated as safety issue: Yes ] Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B [ Time Frame: During the 7 days after each study vaccination ] [ Designated as safety issue: Yes ] Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B [ Time Frame: During the 7 days after each study vaccination ] [ Designated as safety issue: Yes ] Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination [ Time Frame: During the 21 days after each vaccination ] [ Designated as safety issue: Yes ] UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities. Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) [ Time Frame: Up to 180 days after the last vaccination ] [ Designated as safety issue: Yes ] A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Original Secondary Outcome Measures ^ICMJE (submitted: August 12, 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 and new onset of chronic illness [ Time Frame: Up to 180 days after the last vaccination ] [ Designated as safety issue: Yes ]
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 a Healthy Pediatric Population in the USA
Official Title ^ICMJE	A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population
Brief Summary	The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
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
Intervention ^ICMJE	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) 0.5 mL intramuscular injection on Day 0 and Day 21 Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) 0.25 mL intramuscular injection on Day 0 and Day 21 Biological: Placebo Placebo
Study Arm (s)	Placebo Comparator: Placebo Placebo Intervention: Biological: Placebo Experimental: CSL425 (7.5 mcg) 7.5 mcg of hemagglutinin antigen per dose Intervention: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) Experimental: CSL425 (15 mcg) 15 mcg of hemagglutinin antigen per dose Intervention: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Publications *	Not Provided
* 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	473
Completion Date	April 2010
Primary Completion Date	November 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 gestation. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Gender	Both
Ages	6 Months to 9 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00958243
Other Study ID Numbers ^ICMJE	CSLCT-CAL-09-62
Has Data Monitoring Committee	Yes
Responsible Party	CSL Limited
Study Sponsor ^ICMJE	CSL Limited
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	CSL Limited
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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