A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
- Conditions
- Influenza
- Interventions
- Biological: PlaceboBiological: CSL425
- Registration Number
- NCT00958126
- Lead Sponsor
- Seqirus
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1313
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. CSL425 (15 mcg) CSL425 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. CSL425 (7.5 mcg) CSL425 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 CSL425 (30 mcg) CSL425 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
- Primary Outcome Measures
Name Time Method Seroconversion Rate 21 Days After the First Vaccination 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.
Seroconversion Rate 21 Days After the Second Vaccination 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.
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 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 Outcome Measures
Name Time Method Frequency and Intensity of Solicited Adverse Events After the First Vaccination During the 7 days 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.
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 Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) Up to 180 days after the last vaccination 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 Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI 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.
Trial Locations
- Locations (1)
Study Site
🇺🇸Salt Lake City, Utah, United States