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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00938639




Registration number
NCT00938639
Ethics application status
Date submitted
13/07/2009
Date registered
14/07/2009
Date last updated
28/06/2018

Titles & IDs
Public title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Scientific 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.
Secondary ID [1] 0 0
CSLCT-CAL-09-59
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza Caused by the Novel Influenza A (H1N1) Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CSL425
Treatment: Other - CSL425

Experimental: CSL425 (15 mcg) - 15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Experimental: CSL425 (30 mcg) - 30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21


Treatment: Other: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

Treatment: Other: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
Timepoint [1] 0 0
Before and 21 days after the first vaccination
Primary outcome [2] 0 0
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
Timepoint [2] 0 0
Before and 21 days after the second vaccination
Primary outcome [3] 0 0
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
Timepoint [3] 0 0
Before and 21 days after the first vaccination
Primary outcome [4] 0 0
GMFI in the HI and MN Antibody Titer After the Second Vaccination
Timepoint [4] 0 0
Before and 21 days after the second vaccination
Primary outcome [5] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Timepoint [5] 0 0
21 days after the first vaccination
Primary outcome [6] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Timepoint [6] 0 0
21 days after the second vaccination
Secondary outcome [1] 0 0
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
Timepoint [1] 0 0
Before and 21 days after the first vaccination
Secondary outcome [2] 0 0
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
Timepoint [2] 0 0
Before and 21 days after the second vaccination
Secondary outcome [3] 0 0
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
Timepoint [3] 0 0
Before and 21 days after the first vaccination
Secondary outcome [4] 0 0
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
Timepoint [4] 0 0
Before and 21 days after the second vaccination
Secondary outcome [5] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
Timepoint [5] 0 0
21 days after the first vaccination
Secondary outcome [6] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
Timepoint [6] 0 0
21 days after the second vaccination
Secondary outcome [7] 0 0
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
Timepoint [7] 0 0
Before and 21 days after each vaccination
Secondary outcome [8] 0 0
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
Timepoint [8] 0 0
Before and 21 days after each vaccination
Secondary outcome [9] 0 0
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
Timepoint [9] 0 0
21 days and 180 days after the second vaccination
Secondary outcome [10] 0 0
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
Timepoint [10] 0 0
180 days after the second vaccination
Secondary outcome [11] 0 0
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Timepoint [11] 0 0
From Day 0 to Day 6 after the first vaccination
Secondary outcome [12] 0 0
Duration of Solicited Local AEs After the First Vaccination
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Timepoint [13] 0 0
From Day 0 to Day 6 after the second vaccination
Secondary outcome [14] 0 0
Duration of Solicited Local AEs After the Second Vaccination
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Timepoint [15] 0 0
From Day 0 to Day 6 after the first vaccination
Secondary outcome [16] 0 0
Duration of Solicited Systemic AEs After the First Vaccination
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Timepoint [17] 0 0
From Day 0 to Day 6 after the second vaccination
Secondary outcome [18] 0 0
Duration of Solicited Systemic AEs After the Second Vaccination
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Timepoint [19] 0 0
Up to 180 days after the last vaccination
Secondary outcome [20] 0 0
Frequency and Intensity of Unsolicited AEs
Timepoint [20] 0 0
From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

Eligibility
Key inclusion criteria
* Male or female aged >= 18 to < 65 years at the time of providing informed consent.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Study Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00938639
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Director, Vaccines Clinical Development
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00938639