Back to resultsStudy to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Influenza Vaccine GSK1247446A
FluarixTM
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine, Influenza
Eligibility Criteria
Inclusion Criteria:
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fluarix Group
GSK1247446A Group
Arm Description
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Outcomes
Primary Outcome Measures
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the 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 = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Secondary Outcome Measures
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385840
Brief Title
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
Official Title
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 20, 2006 (undefined)
Primary Completion Date
February 1, 2007 (Actual)
Study Completion Date
February 5, 2007 (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 a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
678 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluarix Group
Arm Type
Active Comparator
Arm Description
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A Group
Arm Type
Experimental
Arm Description
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine GSK1247446A
Intervention Description
Single dose, intramuscular injection
Intervention Type
Biological
Intervention Name(s)
FluarixTM
Intervention Description
Single dose, intramuscular injection
Primary 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. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
Time Frame
During the 7-day (Days 0-6) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
Time Frame
During the 7-day (Days 0-6) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Description
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
Time Frame
During the 30-day (Days 0-29) post vaccination period
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 = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Time Frame
During the entire study period (from Day 0 to Day 29)
Secondary Outcome Measure Information:
Title
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Description
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Time Frame
At Day 0 and Day 21
Title
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Description
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame
At Day 21
Title
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Description
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame
At Day 0 and Day 21
Title
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Description
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame
At Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
Subjects who the investigator believes can and will comply with the requirements of the protocol
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
History of hypersensitivity to a previous dose of influenza vaccine.
History of confirmed influenza infection within the last 12 months.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
Acute disease at the time of enrolment.
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
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2301
Country
Norway
Facility Name
GSK Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
GSK Investigational Site
City
Stavanger
ZIP/Postal Code
4010
Country
Norway
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
108708
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108708
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
108708
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
108708
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
108708
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
108708
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 a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
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