A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

Phase 2

Completed

Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus

Interventions: Biological: CSL425

Registration Number: NCT00938639

Lead Sponsor: Seqirus

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSL425 (30 mcg)	CSL425	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
CSL425 (15 mcg)	CSL425	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

Primary Outcome Measures

Name	Time	Method
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
GMFI in the HI and MN Antibody Titer After the Second Vaccination	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.
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination	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.
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination	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.
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination	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.
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 Outcome Measures

Name	Time	Method
Duration of Solicited Systemic AEs After the First Vaccination	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	Solicited AEs included AEs that were specifically sought for.
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group	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. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Duration of Solicited Local AEs After the Second Vaccination	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	Solicited AEs included AEs that were specifically sought for.
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination	From Day 0 to Day 6 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.
Duration of Solicited Local AEs After the First Vaccination	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	Solicited AEs included AEs that were specifically sought for.
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group	21 days after the second vaccination	Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination	21 days and 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.
Frequency and Intensity of Unsolicited AEs	From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs	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.
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group	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. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group	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. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group	21 days after the first vaccination	Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination	Before and 21 days after each 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.
Duration of Solicited Systemic AEs After the Second Vaccination	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	Solicited AEs included AEs that were specifically sought for.
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group	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. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
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
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination	From Day 0 to Day 6 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.
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)	Up to 180 days after the last vaccination	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).
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination	Before and 21 days after each 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).
Frequency and Intensity of Solicited Local AEs After the Second Vaccination	From Day 0 to Day 6 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.
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination	From Day 0 to Day 6 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.