A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population - Full Text View

Purpose

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Condition	Intervention	Phase
Influenza	Biological: CSL's Influenza Virus Vaccine (Afluria) Biological: Influenza Virus Vaccine (Fluzone)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

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:

Geometric Mean Titer 30 Days After the Last Study Vaccination [ Time Frame: 30 days after the last study vaccination ] [ Designated as safety issue: No ]
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination [ Time Frame: 30 days after the last study vaccination ] [ Designated as safety issue: No ]
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

Secondary Outcome Measures:

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
Frequency and Intensity of Unsolicited Adverse Events (UAEs) [ Time Frame: 30 days after each vaccination ] [ Designated as safety issue: Yes ]
UAE stands for Unsolicited Adverse Events
New Onset of Chronic Illnesses (NOCIs) [ Time Frame: 6 months after last study vaccination ] [ Designated as safety issue: Yes ]
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Serious Adverse Events (SAEs) [ Time Frame: 6 months after last study vaccination ] [ Designated as safety issue: Yes ]
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Duration of Local and Systemic Solicited Symptoms, Cohort B [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Duration of Local and Systemic Solicited Symptoms, Cohort C [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	1474
Study Start Date:	September 2009
Study Completion Date:	May 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Afluria Cohort A Age 6 months to < 3 years	Biological: CSL's Influenza Virus Vaccine (Afluria) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Experimental: Afluria Cohort B Age 3 to < 9 years	Biological: CSL's Influenza Virus Vaccine (Afluria) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Experimental: Afluria Cohort C Age 9 to < 18 years	Biological: CSL's Influenza Virus Vaccine (Afluria) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort A Age 6 months to < 3 years	Biological: Influenza Virus Vaccine (Fluzone) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort B Age 3 to < 9 years	Biological: Influenza Virus Vaccine (Fluzone) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Active Comparator: Fluzone Cohort C Age 9 to < 18 years	Biological: Influenza Virus Vaccine (Fluzone) 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

Known hypersensitivity to a previous dose of influenza 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: NCT00959049

Locations

United States, Arizona

Chandler, Arizona, United States, 85224
United States, Arkansas

Harrisburg, Arkansas, United States, 72432

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205

Mountain Home, Arkansas, United States, 72653
United States, Florida

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

Bardstown, Kentucky, United States, 40004
United States, Nebraska

Omaha, Nebraska, United States, 68134
United States, New York

Binghamton, New York, United States, 13901

Elmira, New York, United States, 14901
United States, Ohio
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Cincinnati, Ohio, United States, 45229
United States, Oklahoma

Warr Acres, Oklahoma, United States, 73132
United States, Pennsylvania
UPMC / Community Medicine Inc
Greenville, Pennsylvania, United States, 16125
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, United States, 15650

Pittsburgh, Pennsylvania, United States, 15241
Pediatric Alliance Greentree Division
Pittsburgh, Pennsylvania, United States, 15220
South Hills Pediatrics
Pittsburgh, Pennsylvania, United States, 15227
United States, Utah

Salt Lake City, Utah, United States, 84121

Salt Lake City, Utah, United States, 84109

Salt Lake City, Utah, United States, 84124

South Jordan, Utah, United States, 84095
United States, Virginia

Burke, Virginia, United States, 22015

Vienna, Virginia, United States, 22180

Sponsors and Collaborators

CSL Limited

More Information

No publications provided

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00959049 History of Changes
Other Study ID Numbers:	CSLCT-USF-07-36
Study First Received:	August 12, 2009
Results First Received:	July 3, 2011
Last Updated:	August 25, 2011
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 May 22, 2013