Study to Evaluate the Safety and Immune Response of Two-D... | NCT00510874 | Trialant
NCT00510874
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 17, 2018Actual
Enrollment
780Actual
Phase
Phase 1
Conditions
Influenza
Interventions
Pumarixâ„¢
Pandemrix â„¢
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00510874
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
110028
Secondary IDs
Not provided
Brief Title
Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
Official Title
A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 28, 2007
Primary Completion Date
Jun 17, 2008Actual
Completion Date
Oct 24, 2008Actual
First Submitted Date
Aug 1, 2007
First Submission Date that Met QC Criteria
Aug 1, 2007
First Posted Date
Aug 2, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2013
Results First Submitted that Met QC Criteria
Dec 19, 2013
Results First Posted Date
Feb 7, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 2, 2018
Last Update Posted Date
Aug 17, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.
Conditions Module
Conditions
Influenza
Keywords
Influenza
GSK 1557484A vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
780Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pumarix Formulation 1 Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pumarixâ„¢
Pumarix Formulation 2 Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pumarixâ„¢
Pumarix Formulation 3 Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pumarixâ„¢
Pandemrix Formulation A Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pumarixâ„¢
Biological
Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
At Day 42
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
At Day 42
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Within the 7-day follow-up period (Days 0-6) after any vaccination
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Within the 7-day follow-up period (Days 0-6) after any vaccination
Secondary Outcomes
Measure
Description
Time Frame
Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
At Day 21 and Day 182
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Good general health as assessed by medical history and physical examination.
Access to a consistent means of telephone contact
Written informed consent obtained from the subject.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion Criteria:
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Blood pressure abnormalities
Diagnosed with cancer, or treatment for cancer, within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
Presence of an oral temperature ≥ 37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Receipt of cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period.
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21.
Lactating or nursing.
Women of child bearing potential who lack a history of reliable contraceptive practices.
Known receipt of analgesic or antipyretic medication on the day of treatment
Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis. 2010 Jun 1;201(11):1644-53. doi: 10.1086/652701.
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: Pandemrix â„¢
Pandemrix Formulation B Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix â„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pandemrix â„¢
Pumarix Formulation 4 Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pumarixâ„¢
Pumarix Formulation 5 Group
Experimental
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Biological: Pumarixâ„¢
Pumarix Formulation 1 Group
Pumarix Formulation 2 Group
Pumarix Formulation 3 Group
Pumarix Formulation 4 Group
Pumarix Formulation 5 Group
Pandemrix â„¢
Biological
Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Pandemrix Formulation A Group
Pandemrix Formulation B Group
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
From Day 0 to 182
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 and 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.
During the 21-day follow-up period (Days 0-20) after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 and 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.
Between Day 0 and Day 84 after vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
From Day 0 to 182
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
At Days 21 and 182
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
At Days 21 and 182
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
At Days 0, 21 and 182
Anaheim
California
92801
United States
GSK Investigational Site
Miami
Florida
33143
United States
GSK Investigational Site
Stockbridge
Georgia
30281
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Missoula
Montana
59801
United States
GSK Investigational Site
Las Vegas
Nevada
89104
United States
GSK Investigational Site
Halifax
Nova Scotia
B3K 6R8
Canada
GSK Investigational Site
Truro
Nova Scotia
B2N 1L2
Canada
GSK Investigational Site
Sherbrooke
Quebec
J1H 4J6
Canada
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix â„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
FG00078 subjects
FG001152 subjects
FG002151 subjects
FG003151 subjects
FG004148 subjects
FG00550 subjects
FG00650 subjects
COMPLETED
FG00075 subjectsUpto Day 182
FG001148 subjectsUpto Day 182
FG002150 subjectsUpto Day 182
FG003148 subjectsUpto Day 182
FG004141 subjectsUpto Day 182
FG00550 subjectsUpto Day 182
FG00649 subjectsUpto Day 182
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG0033 subjects
FG0047 subjects
FG0050 subjects
FG0061 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix â„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00078
BG001152
BG002151
BG003151
BG004148
BG00550
BG00650
BG007780
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00038.5± 12.85
BG00138.1± 12.10
BG00239.0± 12.59
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00045
BG00183
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Count of Participants
Participants
At Day 42
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003
Title
Denominators
Categories
Title
Measurements
OG00013
OG001140
OG002131
OG003
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 42
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Pumarix Formulation 3 Group
Primary
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Count of Participants
Participants
At Day 42
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Pumarix Formulation 3 Group
Primary
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
Within the 7-day follow-up period (Days 0-6) after any vaccination
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Pumarix Formulation 3 Group
Primary
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
Within the 7-day follow-up period (Days 0-6) after any vaccination
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Primary
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
From Day 0 to 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Primary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 and 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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
During the 21-day follow-up period (Days 0-20) after vaccination.
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Primary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 and 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.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
Between Day 0 and Day 84 after vaccination.
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Primary
Number of Subjects With Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Posted
Count of Participants
Participants
From Day 0 to 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Secondary
Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 21 and Day 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Pumarix Formulation 3 Group
Secondary
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Count of Participants
Participants
At Days 21 and 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Secondary
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Geometric Mean
95% Confidence Interval
Fold increase
At Days 21 and 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Secondary
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Posted
Count of Participants
Participants
At Days 0, 21 and 182
ID
Title
Description
OG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG002
Time Frame
Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pumarix Formulation 1 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
0
78
45
78
EG001
Pumarix Formulation 2 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
2
152
137
152
EG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1
151
132
151
EG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
2
151
146
151
EG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix â„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1
148
131
148
EG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1
50
48
50
EG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarixâ„¢ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
0
50
42
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ascites
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG0030 affected151 at risk
EG0041 affected148 at risk
EG0050 affected50 at risk
EG0060 affected50 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0021 affected151 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0011 affected152 at risk
EG0020 affected151 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0011 affected152 at risk
EG0020 affected151 at risk
EG003
Gastroenteritis clostridial
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0011 affected152 at risk
EG0020 affected151 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Rectal perforation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
MedDRA
Systematic Assessment
EG00018 affected78 at risk
EG001133 affected152 at risk
EG002130 affected151 at risk
EG003139 affected151 at risk
EG004124 affected148 at risk
EG00548 affected50 at risk
EG00642 affected50 at risk
Redness
General disorders
MedDRA
Systematic Assessment
EG0000 affected78 at risk
EG0017 affected152 at risk
EG0022 affected151 at risk
EG003
Swelling
General disorders
MedDRA
Systematic Assessment
EG0000 affected78 at risk
EG00112 affected152 at risk
EG00210 affected151 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG00016 affected78 at risk
EG00164 affected152 at risk
EG00250 affected151 at risk
EG003
Headache
General disorders
MedDRA
Systematic Assessment
EG00025 affected78 at risk
EG00171 affected152 at risk
EG00261 affected151 at risk
EG003
Joint pain
General disorders
MedDRA
Systematic Assessment
EG00012 affected78 at risk
EG00149 affected152 at risk
EG00236 affected151 at risk
EG003
Muscle aches
General disorders
MedDRA
Systematic Assessment
EG00015 affected78 at risk
EG00174 affected152 at risk
EG00264 affected151 at risk
EG003
Shivering
General disorders
MedDRA
Systematic Assessment
EG0004 affected78 at risk
EG00118 affected152 at risk
EG00221 affected151 at risk
EG003
Sweating
General disorders
MedDRA
Systematic Assessment
EG0006 affected78 at risk
EG00123 affected152 at risk
EG00212 affected151 at risk
EG003
Fever
General disorders
MedDRA
Systematic Assessment
EG0000 affected78 at risk
EG0014 affected152 at risk
EG0024 affected151 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0003 affected78 at risk
EG00110 affected152 at risk
EG0026 affected151 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0005 affected78 at risk
EG0015 affected152 at risk
EG0024 affected151 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0003 affected78 at risk
EG0013 affected152 at risk
EG0023 affected151 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0000 affected78 at risk
EG0013 affected152 at risk
EG0022 affected151 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-20 following vaccination.
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0006 affected78 at risk
EG0014 affected152 at risk
EG00214 affected151 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0003 affected78 at risk
EG0014 affected152 at risk
EG0023 affected151 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0003 affected78 at risk
EG00111 affected152 at risk
EG0026 affected151 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0005 affected78 at risk
EG0015 affected152 at risk
EG0024 affected151 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0003 affected78 at risk
EG0015 affected152 at risk
EG0022 affected151 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
Assessed within Days 0-84 following vaccination.
EG0000 affected78 at risk
EG0010 affected152 at risk
EG0020 affected151 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C556153
pandemrix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0050 subjects
FG0061 subjects
38.7
± 11.25
BG00438.7± 12.20
BG00539.2± 12.21
BG00639.9± 13.18
BG00738.8± 12.22
87
BG003100
BG00478
BG00532
BG00624
BG007449
Male
BG00033
BG00169
BG00264
BG00351
BG00470
BG00518
BG00626
BG007331
140
OG004142
OG00549
OG00650
135
OG004131
OG00547
OG00642
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003140
OG004142
OG00549
OG00650
Title
Denominators
Categories
Title
Measurements
OG00010.5(8.2 to 13.5)
OG001464.7(383.4 to 563.4)
OG002320.7(246.9 to 416.6)
OG003480.3(390.5 to 590.7)
OG004347.7(272 to 444.5)
OG005331.6(217.4 to 505.6)
OG006173.9(105.6 to 286.3)
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003140
OG004142
OG00549
OG00650
Title
Denominators
Categories
Title
Measurements
OG00013
OG001140
OG002131
OG003135
OG004131
OG00547
OG00642
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Any Pain
Title
Measurements
OG00018
OG001133
OG002130
OG003139
OG004124
OG00548
OG00642
Any Redness
Title
Measurements
OG0000
OG0017
OG0022
OG003
Any Swelling
Title
Measurements
OG0000
OG00112
OG00210
OG003
OG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Any Fatigue
Title
Measurements
OG00016
OG00164
OG00250
OG00367
OG00469
OG00515
OG00615
Any Headache
Title
Measurements
OG00025
OG00171
OG00261
OG003
Any Joint Pain
Title
Measurements
OG00012
OG00149
OG00236
OG003
Any Muscle Aches
Title
Measurements
OG00015
OG00174
OG00264
OG003
Any Shivering
Title
Measurements
OG0004
OG00118
OG00221
OG003
Any Sweating
Title
Measurements
OG0006
OG00123
OG00212
OG003
Any Fever
Title
Measurements
OG0000
OG0014
OG0023
OG003
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Subjects with MAEs
Title
Measurements
OG00016
OG00129
OG00233
OG00328
OG00434
OG00514
OG00614
Subjects with NOCDs
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Title
Measurements
OG00030
OG00167
OG00260
OG00373
OG00484
OG00526
OG00620
OG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Title
Measurements
OG00035
OG00177
OG00271
OG00381
OG00489
OG00529
OG00623
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00078
OG001152
OG002151
OG003151
OG004148
OG00550
OG00650
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG0032
OG0041
OG0051
OG0060
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003140
OG004142
OG00549
OG00650
Title
Denominators
Categories
H5N1 at Day 21
ParticipantsOG00075
ParticipantsOG001144
ParticipantsOG002146
ParticipantsOG003140
ParticipantsOG004142
ParticipantsOG00549
ParticipantsOG00650
Title
Measurements
OG0006.1(5.2 to 7.1)
OG00122.5(17.8 to 28.6)
OG00219.9(15.7 to 25.3)
OG003
H5N1 at Day 182
ParticipantsOG00074
ParticipantsOG001141
ParticipantsOG002145
ParticipantsOG003138
OG002
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003140
OG004142
OG00549
OG00650
Title
Denominators
Categories
H5N1 at Day 21
ParticipantsOG00075
ParticipantsOG001144
ParticipantsOG002146
ParticipantsOG003140
ParticipantsOG004142
ParticipantsOG00549
ParticipantsOG00650
Title
Measurements
OG0005
OG00160
OG00260
OG003
H5N1 at Day 182
ParticipantsOG00074
ParticipantsOG001141
ParticipantsOG002145
ParticipantsOG003138
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Units
Counts
Participants
OG00075
OG001144
OG002146
OG003140
OG004142
OG00549
OG00650
Title
Denominators
Categories
H5N1at Day 21
ParticipantsOG00075
ParticipantsOG001144
ParticipantsOG002146
ParticipantsOG003140
ParticipantsOG004142
ParticipantsOG00549
ParticipantsOG00650
Title
Measurements
OG0001.2(1.0 to 1.4)
OG0014.5(3.6 to 5.7)
OG0024.0(3.1 to 5.1)
OG003
H5N1at Day 182
ParticipantsOG00074
ParticipantsOG001141
ParticipantsOG002145
ParticipantsOG003138
Pumarix Formulation 3 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG003
Pandemrix Formulation A Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG004
Pandemrix Formulation B Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG005
Pumarix Formulation 4 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
OG006
Pumarix Formulation 5 Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).