Influenza Caused by the Novel Influenza A (H1N1) VirusPhase 2NCT00938639
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
A Phase 2 study testing CSL425 in people with Influenza Caused by the Novel Influenza A (H1N1) Virus, run by Seqirus at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Caused by the Novel Influenza A (H1N1) Virus
- What is being tested?
- CSL425
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged >= 18 to < 65 years at the time of providing informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- CSL425
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL425Biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
CSL425Biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
| Study group | Role | What they receive |
|---|---|---|
| CSL425 (15 mcg) | Experimental | 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 Receives: Biological: CSL425 |
| CSL425 (30 mcg) | Experimental | 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 Receives: Biological: CSL425 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Measured: Before and 21 days after the first vaccination
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Measured: Before and 21 days after the second vaccination
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Measured: Before and 21 days after the first vaccination
GMFI in the HI and MN Antibody Titer After the Second Vaccination
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Measured: Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Measured: 21 days after the first vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Measured: 21 days after the second vaccination
Secondary outcomes (20)
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: Before and 21 days after the first vaccination
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: Before and 21 days after the second vaccination
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: Before and 21 days after the first vaccination
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: 21 days after the first vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Measured: 21 days after the second vaccination
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Measured: Before and 21 days after each vaccination
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination).
Measured: Before and 21 days after each vaccination
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.
Measured: 21 days and 180 days after the second vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
Measured: 180 days after the second vaccination
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.
Measured: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Local AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: 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
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.
Measured: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Local AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: 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
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Measured: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Systemic AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: 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
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Measured: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Systemic AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: 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
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. 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).
Measured: Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited AEs
Unsolicited AEs included AEs other than those specifically sought for.
The grading definitions were:
Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.
Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.
Severe (Grade 3): Incapacitating, with inability to work or do usual activities.
Measured: From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Caused by the Novel Influenza A (H1N1) VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Vaccines Clinical Development, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938639
- Sponsor's protocol ID
- CSLCT-CAL-09-59
- Status last verified
- Apr 2018
- First submitted
- 13 Jul 2009
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 19745216
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00938639
- Acronym / sponsor ID
- CSLCT-CAL-09-59
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 21 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL425 (15 mcg) | Experimental | Biological: CSL42515 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
| CSL425 (30 mcg) | Experimental | Biological: CSL42530 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female aged >= 18 to < 65 years at the time of providing informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL425CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume) | Biological | CSL425 (15 mcg) |
| CSL425CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume) | Biological | CSL425 (30 mcg) |
Primary outcome
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
Time frame: Before and 21 days after the first vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
Time frame: Before and 21 days after the second vaccination
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
Time frame: Before and 21 days after the first vaccination
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
GMFI in the HI and MN Antibody Titer After the Second Vaccination
Time frame: Before and 21 days after the second vaccination
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Time frame: 21 days after the first vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Time frame: 21 days after the second vaccination
20 secondary outcomes
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
Time frame: Before and 21 days after the first vaccination
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
Time frame: Before and 21 days after the second vaccination
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
Time frame: Before and 21 days after the first vaccination
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
Time frame: Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
Time frame: 21 days after the first vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
Time frame: 21 days after the second vaccination
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
Time frame: Before and 21 days after each vaccination
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
Time frame: Before and 21 days after each vaccination
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
Time frame: 21 days and 180 days after the second vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
Time frame: 180 days after the second vaccination
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Time frame: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Local AEs After the First Vaccination
Time frame: 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
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Time frame: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Local AEs After the Second Vaccination
Time frame: 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
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Time frame: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Systemic AEs After the First Vaccination
Time frame: 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
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Time frame: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Systemic AEs After the Second Vaccination
Time frame: 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
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Time frame: Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited AEs
Time frame: From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19745216Greenberg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Vaccines Clinical Development study director
Seqirus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSL425 in people with Influenza Caused by the Novel Influenza A (H1N1) Virus, run by Seqirus at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination (time frame: Before and 21 days after the first vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.