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

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 adults

Condition	Intervention	Phase
Influenza	Biological: 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 Healthy Adults Aged 18 Years and Older

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 the First Vaccination [ Time Frame: 21 days after the first vaccination ] [ Designated as safety issue: No ]
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Seroconversion Rate 21 Days After the Second Vaccination [ Time Frame: 21 days after the second 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 the First Vaccination [ Time Frame: 21 days after the first vaccination ] [ Designated as safety issue: No ]
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination [ Time Frame: 21 days after the second vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency and Intensity of Solicited Adverse Events After the First Vaccination [ Time Frame: During the 7 days after the first vaccination ] [ Designated as safety issue: Yes ]
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
Duration of Solicited Local Adverse Events After the First Vaccination [ Time Frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs ] [ Designated as safety issue: Yes ]
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) [ 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 (eg, diabetes, asthma).
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination [ Time Frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI ] [ Designated as safety issue: Yes ]
Unsolicited adverse event (UAE) grading:

Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.

Grade 3 (severe): Symptoms that prevented normal, everyday activities.

Enrollment:	1313
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
Experimental: CSL425 (7.5 mcg) 7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21	Biological: CSL425 CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
Experimental: CSL425 (15 mcg) 15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.	Biological: CSL425 CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Experimental: CSL425 (30 mcg) 30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21	Biological: CSL425 CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Placebo Comparator: Placebo Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.	Biological: Placebo Vaccine diluent, thimerosal 0.01% (weight/volume).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female aged 18 and older, inclusive, at the time of providing informed consent.
Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958126

Locations

United States, Alabama
Study Site
Huntsville, Alabama, United States, 35802
United States, California
Study Site
San Diego, California, United States, 92108
United States, Florida
Study Site
Melbourne, Florida, United States, 32935
United States, Illinois
Study Site
Peoria, Illinois, United States, 61602
United States, Indiana
Study Site
South Bend, Indiana, United States, 46601
United States, Louisiana
Study Site
Metairie, Louisiana, United States, 70006
United States, Maryland
Study Site
Baltimore, Maryland, United States, 21205
Study Site
Rockville, Maryland, United States, 20850
United States, Texas
Study Site
Austin, Texas, United States, 78705
Study Site
Fort Worth, Texas, United States, 76135
United States, Utah
Study Site
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

CSL Limited

Investigators

Study Director:

Director, Vaccines Clinical Development

CSL Limited

More Information

Publications:

Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37.

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00958126 History of Changes
Other Study ID Numbers:	CSLCT-CAL-09-61
Study First Received:	August 12, 2009
Results First Received:	July 5, 2012
Last Updated:	August 31, 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