Clinical trial NCT00938639: A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Official title: A Phase II, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the 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 to \< 65 years at the time of providing informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
timeFrame: Before and 21 days after the first vaccination
measure: HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
timeFrame: Before and 21 days after the second vaccination
measure: Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
timeFrame: Before and 21 days after the first vaccination
measure: GMFI in the HI and MN Antibody Titer After the Second Vaccination
timeFrame: Before and 21 days after the second vaccination
measure: Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
timeFrame: 21 days after the first vaccination
measure: Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
timeFrame: 21 days after the second vaccination
Secondary outcomes:
measure: HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
timeFrame: Before and 21 days after the first vaccination
measure: HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
timeFrame: Before and 21 days after the second vaccination
measure: GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
timeFrame: Before and 21 days after the first vaccination
measure: GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
timeFrame: Before and 21 days after the second vaccination
measure: Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
timeFrame: 21 days after the first vaccination
measure: Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
timeFrame: 21 days after the second vaccination
measure: Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
timeFrame: Before and 21 days after each vaccination
measure: Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
timeFrame: Before and 21 days after each vaccination
measure: GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
timeFrame: 21 days and 180 days after the second vaccination
measure: Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
timeFrame: 180 days after the second vaccination
measure: Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
timeFrame: From Day 0 to Day 6 after the first vaccination
measure: Duration of Solicited Local AEs After the First Vaccination
timeFrame: From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7
measure: Frequency and Intensity of Solicited Local AEs After the Second Vaccination
timeFrame: From Day 0 to Day 6 after the second vaccination
measure: Duration of Solicited Local AEs After the Second Vaccination
timeFrame: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7
measure: Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
timeFrame: From Day 0 to Day 6 after the first vaccination
measure: Duration of Solicited Systemic AEs After the First Vaccination
timeFrame: From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7
measure: Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
timeFrame: From Day 0 to Day 6 after the second vaccination
measure: Duration of Solicited Systemic AEs After the Second Vaccination
timeFrame: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7
measure: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
timeFrame: Up to 180 days after the last vaccination
measure: Frequency and Intensity of Unsolicited AEs
timeFrame: From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Study Site
state: South Australia
Study officials:
affiliation: Seqirus
name: Director, Vaccines Clinical Development
role: STUDY_DIRECTOR
References:
citation: Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.