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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958126
• Other study ID #: CSLCT-CAL-09-61
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2009
• Last updated: October 18, 2017
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2017
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 adults

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1313
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
• CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
• Placebo
Vaccine diluent, thimerosal 0.01% (weight/volume).

Locations

Country	Name	City	State
United States	Study Site	Austin	Texas
United States	Study Site	Baltimore	Maryland
United States	Study Site	Fort Worth	Texas
United States	Study Site	Huntsville	Alabama
United States	Study Site	Melbourne	Florida
United States	Study Site	Metairie	Louisiana
United States	Study Site	Peoria	Illinois
United States	Study Site	Rockville	Maryland
United States	Study Site	Salt Lake City	Utah
United States	Study Site	San Diego	California
United States	Study Site	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion Rate 21 Days After the First Vaccination	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.	21 days after the first vaccination
Primary	Seroconversion Rate 21 Days After the Second Vaccination	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.	21 days after the second vaccination
Primary	Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination		21 days after the first vaccination
Primary	Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination		21 days after the second vaccination
Secondary	Frequency and Intensity of Solicited Adverse Events After the First Vaccination	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.	During the 7 days after the first vaccination
Secondary	Duration of Solicited Local Adverse Events After the First Vaccination		During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Secondary	Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)	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).	Up to 180 days after the last vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination	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.	Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI