Influenza Caused by the Novel Influenza A (H1N1) Virus Clinical Trial
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.
| Verified date | April 2018 |
| Source | Seqirus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | March 2010 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Study Site | Adelaide | South Australia |
| Lead Sponsor | Collaborator |
|---|---|
| Seqirus |
Australia,
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 20 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Before and 21 days after the first vaccination | |
| Primary | 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. | Before and 21 days after the second vaccination | |
| Primary | 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. | Before and 21 days after the first vaccination | |
| Primary | 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. | Before and 21 days after the second vaccination | |
| Primary | Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination | 21 days after the first vaccination | ||
| Primary | Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination | 21 days after the second vaccination | ||
| Secondary | 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. |
Before and 21 days after the first vaccination | |
| Secondary | 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. |
Before and 21 days after the second vaccination | |
| Secondary | 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. |
Before and 21 days after the first vaccination | |
| Secondary | 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. |
Before and 21 days after the second vaccination | |
| Secondary | 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. | 21 days after the first vaccination | |
| Secondary | 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. | 21 days after the second vaccination | |
| Secondary | 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. |
Before and 21 days after each vaccination | |
| Secondary | 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). |
Before and 21 days after each vaccination | |
| Secondary | 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. | 21 days and 180 days after the second vaccination | |
| Secondary | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination | 180 days after the second vaccination | ||
| Secondary | 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. | From Day 0 to Day 6 after the first vaccination | |
| Secondary | Duration of Solicited Local AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | 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 | 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. | From Day 0 to Day 6 after the second vaccination | |
| Secondary | Duration of Solicited Local AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | 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 | 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. | From Day 0 to Day 6 after the first vaccination | |
| Secondary | Duration of Solicited Systemic AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | 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 | 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. | From Day 0 to Day 6 after the second vaccination | |
| Secondary | Duration of Solicited Systemic AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | 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 | 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). | Up to 180 days after the last vaccination | |
| Secondary | 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. |
From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00940108 -
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
|
Phase 2 |