Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trivalent influenza vaccine GSK 138842A
Fluarix
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring cell culture, Safety, Influenza, Humans, Adults, Immunogenicity, Influenza vaccine, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
- Access to a telephone for scheduled follow-up telephone contacts
- Ability to provide written informed consent
- Healthy subjects as established by medical history and physical examination before entering into the study
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
- Receipt of systemic glucocorticoids within 30 days of study enrollment
- Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
- Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
- Previous vaccination against influenza (2007-2008 influenza season)
- History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
- History of Guillain-Barre Syndrome (GBS)
- Acute disease, febrile illness, or upper respiratory infection at screening.
- History of splenectomy
- Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
- Acquired or congenital coagulation disorders or known thrombocytopenia
- Current treatment with warfarin or heparin derivatives
- Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
- Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GSK 1388442A Group
Fluarix Group
Arm Description
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Outcomes
Primary Outcome Measures
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Number of Subjects With Solicited General Symptoms.
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Number of Subjects With Medically Attended Adverse Events (MAEs).
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Number of Subjects With Unsolicited Adverse Events (AEs).
Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (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 SAE regardless of intensity or relationship to vaccination.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
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/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00693706
Brief Title
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Official Title
Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2, 2008 (undefined)
Primary Completion Date
March 1, 2009 (Actual)
Study Completion Date
March 26, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
cell culture, Safety, Influenza, Humans, Adults, Immunogenicity, Influenza vaccine, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK 1388442A Group
Arm Type
Experimental
Arm Description
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A 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 to 49 years of age at the time of vaccination received 1 dose of 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)
Trivalent influenza vaccine GSK 138842A
Intervention Description
IM injection on Day 0
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
IM injection on Day 0
Primary Outcome Measure Information:
Title
Number of Subjects With Solicited Local Symptoms.
Description
Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Time Frame
During the 7-day (Days 0-6) post vaccination period
Title
Number of Subjects With Solicited General Symptoms.
Description
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Time Frame
During the 7-day (Days 0-6) post vaccination period
Title
Number of Subjects With Medically Attended Adverse Events (MAEs).
Description
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
Time Frame
During the entire study period (Days 0-182)
Title
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
Description
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame
During the entire study period (Days 0-182)
Title
Number of Subjects With Unsolicited Adverse Events (AEs).
Description
Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Time Frame
During the 90-day (Days 0-89) post-vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs).
Description
Serious adverse events (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 SAE regardless of intensity or relationship to vaccination.
Time Frame
During the entire study period (Days 0-182)
Title
Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.
Description
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
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 with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame
At 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/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame
At Day 21
Title
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
Description
GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame
At Day 0 and Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol
A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
Access to a telephone for scheduled follow-up telephone contacts
Ability to provide written informed consent
Healthy subjects as established by medical history and physical examination before entering into the study
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
Receipt of systemic glucocorticoids within 30 days of study enrollment
Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
Previous vaccination against influenza (2007-2008 influenza season)
History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
History of Guillain-Barre Syndrome (GBS)
Acute disease, febrile illness, or upper respiratory infection at screening.
History of splenectomy
Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
Acquired or congenital coagulation disorders or known thrombocytopenia
Current treatment with warfarin or heparin derivatives
Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza
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
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110127
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
110127
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110127
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
110127
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
110127
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
110127
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110127
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
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