Back to resultsStudy to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Fluarix™
GSK1247446A
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine, Prophylaxis Influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
Exclusion Criteria:
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Previous vaccination against influenza in 2006
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
GSK1247446A Formulation 1 Group
GSK1247446A Formulation 2 Group
Fluarix Group
Arm Description
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Outcomes
Primary Outcome Measures
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
Secondary Outcome Measures
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00374842
Brief Title
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Official Title
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 3, 2006 (undefined)
Primary Completion Date
November 1, 2006 (Actual)
Study Completion Date
November 30, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine, Prophylaxis Influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1247446A Formulation 1 Group
Arm Type
Experimental
Arm Description
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A Formulation 2 Group
Arm Type
Experimental
Arm Description
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
Fluarix Group
Arm Type
Active Comparator
Arm Description
Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Fluarix™
Intervention Description
GlaxoSmithKline Biologicals' licensed influenza vaccine
Intervention Type
Biological
Intervention Name(s)
GSK1247446A
Intervention Description
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
Primary Outcome Measure Information:
Title
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Description
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Time Frame
At Day 0 and at Day 21.
Title
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
Description
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Time Frame
At Day 0 and at Day 21.
Title
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Description
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
Time Frame
At Day 21.
Title
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Description
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
Time Frame
At Day 21.
Secondary Outcome Measure Information:
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Time Frame
Within the 7-day follow-up period (Days 0-6) after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Time Frame
Within the 7-day follow-up period (Days 0-6) after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame
Within the 30-day follow-up period (Days 0-29) after vaccination
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Time Frame
From study start to study end, from Day 0 to Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female aged 18-59 years at the time of the first vaccination.
Free of obvious health problems
Exclusion Criteria:
Use of non-registered products
Administration of immune-modifying drugs.
Administration of vaccine 30 days before enrolment in study.
Immunosuppressive or immunodeficient condition.
Hypersensitivity to a previous dose of influenza vaccine
Previous vaccination against influenza in 2006
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
History of confirmed influenza infection within the last 12 Months.
Acute disease at the time of enrolment/vaccination.
History of allergy or reactions likely to be exacerbated by any component of the vaccine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108656
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108656
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108656
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108656
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108656
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
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