Clinical trial NCT00958126: A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 1313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility 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.

Primary outcomes:
measure: Seroconversion Rate 21 Days After the First Vaccination
timeFrame: 21 days after the first vaccination
measure: Seroconversion Rate 21 Days After the Second Vaccination
timeFrame: 21 days after the second vaccination
measure: Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
timeFrame: 21 days after the first vaccination
measure: Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
timeFrame: 21 days after the second vaccination
Secondary outcomes:
measure: Frequency and Intensity of Solicited Adverse Events After the First Vaccination
timeFrame: During the 7 days after the first vaccination
measure: Duration of Solicited Local Adverse Events After the First Vaccination
timeFrame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
measure: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
timeFrame: Up to 180 days after the last vaccination
measure: Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
timeFrame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Study Site
state: Alabama
city: San Diego
country: United States
facility: Study Site
state: California
city: Melbourne
country: United States
facility: Study Site
state: Florida
city: Peoria
country: United States
facility: Study Site
state: Illinois
city: South Bend
country: United States
facility: Study Site
state: Indiana
city: Metairie
country: United States
facility: Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Study Site
state: Maryland
city: Rockville
country: United States
facility: Study Site
state: Maryland
city: Austin
country: United States
facility: Study Site
state: Texas
city: Fort Worth
country: United States
facility: Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Study Site
state: Utah
Study officials:
affiliation: Seqirus
name: Director, Vaccines Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1086/656601.