Back to resultsImmunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Czechia
Study Type
Interventional
Intervention
GSK Biologicals' quadrivalent influenza vaccine
GSK Biologicals' trivalent influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Primary study, immunogenicity, safety
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Quadrivalent influenza vaccine GSK 2115160A Group 1
Quadrivalent influenza vaccine GSK 2115160A Group 2
Trivalent influenza vaccine GSK 2115160A Group 1
Trivalent influenza vaccine GSK 2115160A Group 2
Arm Description
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Outcomes
Primary Outcome Measures
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
Secondary Outcome Measures
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
Number of Subjects Reporting 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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00714285
Brief Title
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Official Title
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 14, 2008 (undefined)
Primary Completion Date
January 28, 2009 (Actual)
Study Completion Date
January 28, 2009 (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 safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Primary study, immunogenicity, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadrivalent influenza vaccine GSK 2115160A Group 1
Arm Type
Experimental
Arm Description
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Arm Title
Quadrivalent influenza vaccine GSK 2115160A Group 2
Arm Type
Experimental
Arm Description
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Arm Title
Trivalent influenza vaccine GSK 2115160A Group 1
Arm Type
Active Comparator
Arm Description
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Arm Title
Trivalent influenza vaccine GSK 2115160A Group 2
Arm Type
Active Comparator
Arm Description
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' quadrivalent influenza vaccine
Intervention Description
Single intramuscular dose on Day 0.
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' trivalent influenza vaccine
Intervention Description
Single intramuscular dose on Day 0.
Primary Outcome Measure Information:
Title
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Description
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
Time Frame
At Day 0 and Day 21
Secondary Outcome Measure Information:
Title
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time Frame
At Day 21
Title
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Description
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time Frame
Day 21
Title
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Description
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Time Frame
At Days 0 and 21
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Time Frame
During a 7 day (Days 0-6) follow-up period after vaccination
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Description
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
Time Frame
During a 7-day follow-up period (Days 0-6) after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Description
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
Time Frame
During a 7-day follow-up period (Days 0-6) after vaccination
Title
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Description
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time Frame
During a 7-day follow-up period (Days 0-6) after vaccination
Title
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Description
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
Time Frame
During the entire study period (Days 0-180)
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
Time Frame
During a 21 day (Days 0-20) follow-up period after vaccination-
Title
Number of Subjects Reporting 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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame
During the entire study period (Days 0-180)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
Written informed consent obtained from the subject.
If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
Confirmed influenza infection within a year preceding the study start.
Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
History of hypersensitivity to a previous dose of influenza vaccine
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of chronic alcohol consumption and/or drug abuse.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
History of administration of experimental/licensed 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
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czechia
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.
Citations:
PubMed Identifier
23688546
Citation
Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224.
Results Reference
derived
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111295
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
111295
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
111295
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
111295
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
111295
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
111295
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
111295
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
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