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

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) Biological: Placebo	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, 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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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).

Enrollment:	473
Study Start Date:	August 2009
Study Completion Date:	April 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo	Biological: Placebo Placebo
Experimental: CSL425 (7.5 mcg) 7.5 mcg of hemagglutinin antigen per dose	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) 0.25 mL intramuscular injection on Day 0 and Day 21
Experimental: CSL425 (15 mcg) 15 mcg of hemagglutinin antigen per dose	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) 0.5 mL intramuscular injection on Day 0 and Day 21

Eligibility

Ages Eligible for Study:	6 Months to 9 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958243

Locations

United States, Arizona

Chandler, Arizona, United States, 85224
United States, Florida

Melbourne, Florida, United States, 32935
United States, Kentucky

Bardstown, Kentucky, United States, 40004
United States, Louisiana

Metairie, Louisiana, United States, 70006
United States, Nebraska

Omaha, Nebraska, United States, 68134
United States, Ohio

Austintown, Ohio, United States, 44515

Cincinnati, Ohio, United States, 45246
United States, Pennsylvania

Latrobe, Pennsylvania, United States, 15650

Pittsburgh, Pennsylvania, United States, 15227
United States, Texas

Austin, Texas, United States, 78705

Fort Worth, Texas, United States, 76135

Houston, Texas, United States, 77030
United States, Utah

Murray, Utah, United States, 84107

Sponsors and Collaborators

CSL Limited

More Information

No publications provided

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00958243 History of Changes
Other Study ID Numbers:	CSLCT-CAL-09-62
Study First Received:	August 12, 2009
Results First Received:	July 13, 2011
Last Updated:	February 10, 2012
Health Authority:	United States: Food and Drug 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