Back to resultsStudy to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Fluarix TM
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Influenza vaccine
Eligibility Criteria
Inclusion Criteria: A male or female age 60 years or older at the time of the vaccination. 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 three 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
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
GSK1247446A Lot 1 Group
GSK1247446A Lot 2 Group
GSK1247446A Lot 3 Group
GSK1247446A Pooled Group
Fluarix Group
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Outcomes
Primary 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/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.
Number of Subjects With Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.
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 related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.
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 = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00321763
Brief Title
Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
Official Title
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 27, 2006 (undefined)
Primary Completion Date
July 1, 2006 (Actual)
Study Completion Date
July 7, 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 phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old 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, Influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1247446A Lot 1 Group
Arm Type
Experimental
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A Lot 2 Group
Arm Type
Experimental
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A Lot 3 Group
Arm Type
Experimental
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Arm Title
GSK1247446A Pooled Group
Arm Type
Experimental
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Arm Title
Fluarix Group
Arm Type
Active Comparator
Arm Description
Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Intervention Description
Single dose, Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluarix TM
Intervention Description
Single dose, Intramuscular injection
Primary 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/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time Frame
At Days 0 and 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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time Frame
At Days 0 and 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 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time Frame
At Day 21
Title
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Description
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related 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 Solicited General Symptoms.
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 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 New Onset of Chronic Diseases (NOCDs).
Description
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.
Time Frame
From Day 0 to Day 180
Title
Number of Subjects With Medically Significant Conditions (MSCs).
Description
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.
Time Frame
From Day 0 to Day 180
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 related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.
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 = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.
Time Frame
During the entire study period (Days 0-180)
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 vaccination.
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 three 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
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
GSK Investigational Site
City
Caen cedex 4
ZIP/Postal Code
14052
Country
France
Facility Name
GSK Investigational Site
City
Gières
ZIP/Postal Code
38610
Country
France
Facility Name
GSK Investigational Site
City
Lagord
ZIP/Postal Code
17140
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59019
Country
France
Facility Name
GSK Investigational Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
GSK Investigational Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
GSK Investigational Site
City
Haag
State/Province
Bayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
GSK Investigational Site
City
Hoehenkirchen-Siegertsbrunn
State/Province
Bayern
ZIP/Postal Code
85635
Country
Germany
Facility Name
GSK Investigational Site
City
Marktl
State/Province
Bayern
ZIP/Postal Code
84533
Country
Germany
Facility Name
GSK Investigational Site
City
Oberaudorf
State/Province
Bayern
ZIP/Postal Code
83080
Country
Germany
Facility Name
GSK Investigational Site
City
Ketzin
State/Province
Brandenburg
ZIP/Postal Code
14669
Country
Germany
Facility Name
GSK Investigational Site
City
Koenigslutter
State/Province
Niedersachsen
ZIP/Postal Code
38154
Country
Germany
Facility Name
GSK Investigational Site
City
Tostedt
State/Province
Niedersachsen
ZIP/Postal Code
21255
Country
Germany
Facility Name
GSK Investigational Site
City
Wolmirstedt
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39326
Country
Germany
Facility Name
GSK Investigational Site
City
Delitzsch
State/Province
Sachsen
ZIP/Postal Code
04509
Country
Germany
Facility Name
GSK Investigational Site
City
Freital
State/Province
Sachsen
ZIP/Postal Code
01705
Country
Germany
Facility Name
GSK Investigational Site
City
Kamenz
State/Province
Sachsen
ZIP/Postal Code
01917
Country
Germany
Facility Name
GSK Investigational Site
City
Pirna
State/Province
Sachsen
ZIP/Postal Code
01796
Country
Germany
Facility Name
GSK Investigational Site
City
Weissenberg
State/Province
Sachsen
ZIP/Postal Code
02627
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Bramstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
24576
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
GSK Investigational Site
City
Goudi / Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
GSK Investigational Site
City
Haidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
GSK Investigational Site
City
Marousi
ZIP/Postal Code
151 26
Country
Greece
Facility Name
GSK Investigational Site
City
Nikaia Piraeus
ZIP/Postal Code
184 54
Country
Greece
Facility Name
GSK Investigational Site
City
Orestiada
ZIP/Postal Code
682 00
Country
Greece
Facility Name
GSK Investigational Site
City
Papagos/Athens
ZIP/Postal Code
15669
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
GSK Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2317
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
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620078
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kazan
ZIP/Postal Code
420015
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
410018
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 7AG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
State/Province
Glamorgan
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G81 4SA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Buckshaw Village, Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edgbaston, Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Waterloo, Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
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
107192
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
107192
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
107192
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
107192
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
107192
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 Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
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