Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00510874
• Collaborator: (none)
• Enrollment: 780
• Locations: 10
• Arms: 7
• Duration (Months): 14.9
• Patients Per Site: 78
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Pumarix™; Biological: Pandemrix ™	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 780 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jul 28, 2007
• Actual Primary Completion Date: Jun 17, 2008
• Actual Study Completion Date: Oct 24, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Biological: Pumarix™; 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.
Experimental: 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).	Biological: Pumarix™; 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.
Experimental: 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).	Biological: Pumarix™; 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.
Experimental: 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).	Biological: Pandemrix ™; 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.
Experimental: 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).	Biological: Pandemrix ™; 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.
Experimental: 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).	Biological: Pumarix™; 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.
Experimental: 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).	Biological: Pumarix™; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Day 42]

   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.

2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Day 42]

   Titers are presented as geometric mean titers (GMTs).

3. Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Day 42]

   A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

4. Number of Subjects With Solicited Local Symptoms. [Within the 7-day follow-up period (Days 0-6) after any vaccination]

   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).

5. Number of Subjects With Solicited General Symptoms. [Within the 7-day follow-up period (Days 0-6) after any vaccination]

   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.

6. Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). [From Day 0 to 182]

   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.

7. Number of Subjects With Unsolicited Adverse Events (AEs). [During the 21-day follow-up period (Days 0-20) after vaccination.]

   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.

8. Number of Subjects With Unsolicited Adverse Events (AEs). [Between Day 0 and Day 84 after vaccination.]

   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.

9. Number of Subjects With Any Serious Adverse Events (SAEs). [From Day 0 to 182]

   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.

Secondary Outcome Measures

1. Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Day 21 and Day 182]

   Titers are presented as geometric mean titers (GMTs).

2. Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Days 21 and 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.

3. Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Days 21 and 182]

   GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.

4. Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. [At Days 0, 21 and 182]

   A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Huntsville	Alabama	United States	35802
2	GSK Investigational Site	Anaheim	California	United States	92801
3	GSK Investigational Site	Miami	Florida	United States	33143
4	GSK Investigational Site	Stockbridge	Georgia	United States	30281
5	GSK Investigational Site	Lenexa	Kansas	United States	66219
6	GSK Investigational Site	Missoula	Montana	United States	59801
7	GSK Investigational Site	Las Vegas	Nevada	United States	89104
8	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
9	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
10	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 4J6

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00510874
• Other Study ID Numbers: 110028
• First Posted: Aug 2, 2007
• Last Update Posted: Aug 17, 2018
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Influenza; GSK 1557484A vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Period Title: Overall Study
STARTED	78	152	151	151	148	50	50
COMPLETED	75	148	150	148	141	50	49
NOT COMPLETED	3	4	1	3	7	0	1

Baseline Characteristics

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group	Total
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).	Total of all reporting groups
Overall Participants	78	152	151	151	148	50	50	780
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.5 (12.85)	38.1 (12.10)	39.0 (12.59)	38.7 (11.25)	38.7 (12.20)	39.2 (12.21)	39.9 (13.18)	38.8 (12.22)
Sex: Female, Male (Count of Participants)
Female	45 57.7%	83 54.6%	87 57.6%	100 66.2%	78 52.7%	32 64%	24 48%	449 57.6%
Male	33 42.3%	69 45.4%	64 42.4%	51 33.8%	70 47.3%	18 36%	26 52%	331 42.4%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	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.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
Count of Participants [Participants]	13 16.7%	140 92.1%	131 86.8%	135 89.4%	131 88.5%	47 94%	42 84%

2. Primary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
Geometric Mean (95% Confidence Interval) [Titers]	10.5	464.7	320.7	480.3	347.7	331.6	173.9

3. Primary Outcome

Title	Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
Count of Participants [Participants]	13 16.7%	140 92.1%	131 86.8%	135 89.4%	131 88.5%	47 94%	42 84%

4. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	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).
Time Frame	Within the 7-day follow-up period (Days 0-6) after any vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Any Pain	18 23.1%	133 87.5%	130 86.1%	139 92.1%	124 83.8%	48 96%	42 84%
Any Redness	0 0%	7 4.6%	2 1.3%	9 6%	6 4.1%	1 2%	0 0%
Any Swelling	0 0%	12 7.9%	10 6.6%	21 13.9%	9 6.1%	4 8%	0 0%

5. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	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.
Time Frame	Within the 7-day follow-up period (Days 0-6) after any vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Any Fatigue	16 20.5%	64 42.1%	50 33.1%	67 44.4%	69 46.6%	15 30%	15 30%
Any Headache	25 32.1%	71 46.7%	61 40.4%	66 43.7%	61 41.2%	11 22%	19 38%
Any Joint Pain	12 15.4%	49 32.2%	36 23.8%	53 35.1%	39 26.4%	11 22%	11 22%
Any Muscle Aches	15 19.2%	74 48.7%	64 42.4%	86 57%	63 42.6%	19 38%	21 42%
Any Shivering	4 5.1%	18 11.8%	21 13.9%	27 17.9%	17 11.5%	8 16%	6 12%
Any Sweating	6 7.7%	23 15.1%	12 7.9%	24 15.9%	21 14.2%	5 10%	1 2%
Any Fever	0 0%	4 2.6%	3 2%	12 7.9%	11 7.4%	1 2%	0 0%

6. Primary Outcome

Title	Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
Description	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.
Time Frame	From Day 0 to 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Subjects with MAEs	16 20.5%	29 19.1%	33 21.9%	28 18.5%	34 23%	14 28%	14 28%
Subjects with NOCDs	0 0%	1 0.7%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs).
Description	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.
Time Frame	During the 21-day follow-up period (Days 0-20) after vaccination.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Count of Participants [Participants]	30 38.5%	67 44.1%	60 39.7%	73 48.3%	84 56.8%	26 52%	20 40%

8. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs).
Description	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.
Time Frame	Between Day 0 and Day 84 after vaccination.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Count of Participants [Participants]	35 44.9%	77 50.7%	71 47%	81 53.6%	89 60.1%	29 58%	23 46%

9. Primary Outcome

Title	Number of Subjects With Any Serious Adverse Events (SAEs).
Description	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.
Time Frame	From Day 0 to 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	78	152	151	151	148	50	50
Count of Participants [Participants]	0 0%	2 1.3%	1 0.7%	2 1.3%	1 0.7%	1 2%	0 0%

10. Secondary Outcome

Title	Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	Titers are presented as geometric mean titers (GMTs).
Time Frame	At Day 21 and Day 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
H5N1 at Day 21	6.1	22.5	19.9	23.5	16.8	23.0	20.8
H5N1 at Day 182	5.6	27.8	22.6	26.1	22.6	32.5	20.0

11. Secondary Outcome

Title	Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	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.
Time Frame	At Days 21 and 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
H5N1 at Day 21	5 6.4%	60 39.5%	60 39.7%	64 42.4%	54 36.5%	23 46%	21 42%
H5N1 at Day 182	2 2.6%	77 50.7%	66 43.7%	67 44.4%	62 41.9%	24 48%	23 46%

12. Secondary Outcome

Title	Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
Time Frame	At Days 21 and 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	142	49	50
H5N1at Day 21	1.2	4.5	4.0	4.7	3.3	4.1	4.2
H5N1at Day 182	1.1	5.6	4.5	5.2	4.5	5.8	4.0

13. Secondary Outcome

Title	Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Description	A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
Time Frame	At Days 0, 21 and 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pumarix Formulation 1 Group	Pumarix Formulation 2 Group	Pumarix Formulation 3 Group	Pandemrix Formulation A Group	Pandemrix Formulation B Group	Pumarix Formulation 4 Group	Pumarix Formulation 5 Group
Arm/Group Description	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).	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).	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).	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).	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).	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).	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).
Measure Participants	75	144	146	140	143	49	50
H5N1 at Day 0	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%
H5N1 at Day 21	5 6.4%	60 39.5%	60 39.7%	64 42.4%	54 36.5%	23 46%	21 42%
H5N1 at Day 182	2 2.6%	77 50.7%	66 43.7%	68 45%	63 42.6%	26 52%	23 46%

Adverse Events

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.
Arm/Group Title	Pumarix Formulation 1 Group		Pumarix Formulation 2 Group		Pumarix Formulation 3 Group		Pandemrix Formulation A Group		Pandemrix Formulation B Group		Pumarix Formulation 4 Group		Pumarix Formulation 5 Group
Arm/Group Description	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).		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).		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).		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).		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).		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).		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).
All Cause Mortality
	Pumarix Formulation 1 Group		Pumarix Formulation 2 Group		Pumarix Formulation 3 Group		Pandemrix Formulation A Group		Pandemrix Formulation B Group		Pumarix Formulation 4 Group		Pumarix Formulation 5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pumarix Formulation 1 Group		Pumarix Formulation 2 Group		Pumarix Formulation 3 Group		Pandemrix Formulation A Group		Pandemrix Formulation B Group		Pumarix Formulation 4 Group		Pumarix Formulation 5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		2/152 (1.3%)		1/151 (0.7%)		2/151 (1.3%)		1/148 (0.7%)		1/50 (2%)		0/50 (0%)
Gastrointestinal disorders
Ascites	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Pancreatitis	0/78 (0%)		1/152 (0.7%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Rectal perforation	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
General disorders
Chest pain	0/78 (0%)		1/152 (0.7%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Hepatobiliary disorders
Cholelithiasis	0/78 (0%)		1/152 (0.7%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Infections and infestations
Gastroenteritis clostridial	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Pelvic abscess	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Injury, poisoning and procedural complications
Femur fracture	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		1/50 (2%)		0/50 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/78 (0%)		0/152 (0%)		1/151 (0.7%)		0/151 (0%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Cervix carcinoma	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Uterine leiomyoma	0/78 (0%)		0/152 (0%)		0/151 (0%)		1/151 (0.7%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Renal and urinary disorders
Hydronephrosis	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/78 (0%)		0/152 (0%)		0/151 (0%)		1/151 (0.7%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Pulmonary embolism	0/78 (0%)		0/152 (0%)		0/151 (0%)		1/151 (0.7%)		0/148 (0%)		0/50 (0%)		0/50 (0%)
Vascular disorders
Haematoma	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		1/148 (0.7%)		0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Pumarix Formulation 1 Group		Pumarix Formulation 2 Group		Pumarix Formulation 3 Group		Pandemrix Formulation A Group		Pandemrix Formulation B Group		Pumarix Formulation 4 Group		Pumarix Formulation 5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/78 (57.7%)		137/152 (90.1%)		132/151 (87.4%)		146/151 (96.7%)		131/148 (88.5%)		48/50 (96%)		42/50 (84%)
Gastrointestinal disorders
Nausea	3/78 (3.8%)		10/152 (6.6%)		6/151 (4%)		7/151 (4.6%)		5/148 (3.4%)		2/50 (4%)		0/50 (0%)
Nausea	3/78 (3.8%)		11/152 (7.2%)		6/151 (4%)		7/151 (4.6%)		5/148 (3.4%)		2/50 (4%)		0/50 (0%)
General disorders
Pain	18/78 (23.1%)		133/152 (87.5%)		130/151 (86.1%)		139/151 (92.1%)		124/148 (83.8%)		48/50 (96%)		42/50 (84%)
Redness	0/78 (0%)		7/152 (4.6%)		2/151 (1.3%)		9/151 (6%)		6/148 (4.1%)		1/50 (2%)		0/50 (0%)
Swelling	0/78 (0%)		12/152 (7.9%)		10/151 (6.6%)		21/151 (13.9%)		9/148 (6.1%)		4/50 (8%)		0/50 (0%)
Fatigue	16/78 (20.5%)		64/152 (42.1%)		50/151 (33.1%)		67/151 (44.4%)		69/148 (46.6%)		15/50 (30%)		15/50 (30%)
Headache	25/78 (32.1%)		71/152 (46.7%)		61/151 (40.4%)		66/151 (43.7%)		61/148 (41.2%)		11/50 (22%)		19/50 (38%)
Joint pain	12/78 (15.4%)		49/152 (32.2%)		36/151 (23.8%)		53/151 (35.1%)		39/148 (26.4%)		11/50 (22%)		11/50 (22%)
Muscle aches	15/78 (19.2%)		74/152 (48.7%)		64/151 (42.4%)		86/151 (57%)		63/148 (42.6%)		19/50 (38%)		21/50 (42%)
Shivering	4/78 (5.1%)		18/152 (11.8%)		21/151 (13.9%)		27/151 (17.9%)		17/148 (11.5%)		8/50 (16%)		6/50 (12%)
Sweating	6/78 (7.7%)		23/152 (15.1%)		12/151 (7.9%)		24/151 (15.9%)		21/148 (14.2%)		5/50 (10%)		1/50 (2%)
Fever	0/78 (0%)		4/152 (2.6%)		4/151 (2.6%)		12/151 (7.9%)		11/148 (7.4%)		1/50 (2%)		0/50 (0%)
Infections and infestations
Upper respiratory tract infection	0/78 (0%)		3/152 (2%)		2/151 (1.3%)		5/151 (3.3%)		7/148 (4.7%)		2/50 (4%)		4/50 (8%)
Nasopharyngitis	6/78 (7.7%)		4/152 (2.6%)		14/151 (9.3%)		9/151 (6%)		4/148 (2.7%)		2/50 (4%)		2/50 (4%)
Upper respiratory tract infection	3/78 (3.8%)		5/152 (3.3%)		2/151 (1.3%)		7/151 (4.6%)		8/148 (5.4%)		3/50 (6%)		4/50 (8%)
Nervous system disorders
Headache	3/78 (3.8%)		3/152 (2%)		3/151 (2%)		13/151 (8.6%)		12/148 (8.1%)		4/50 (8%)		4/50 (8%)
Headache	3/78 (3.8%)		4/152 (2.6%)		3/151 (2%)		13/151 (8.6%)		12/148 (8.1%)		4/50 (8%)		4/50 (8%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain	5/78 (6.4%)		5/152 (3.3%)		4/151 (2.6%)		10/151 (6.6%)		7/148 (4.7%)		0/50 (0%)		0/50 (0%)
Oropharyngeal pain	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		1/50 (2%)		3/50 (6%)
Rhinorrhoea	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		3/50 (6%)		1/50 (2%)
Pharyngolaryngeal pain	5/78 (6.4%)		5/152 (3.3%)		4/151 (2.6%)		10/151 (6.6%)		7/148 (4.7%)		0/50 (0%)		0/50 (0%)
Oropharyngeal pain	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		1/50 (2%)		4/50 (8%)
Rhinorrhoea	0/78 (0%)		0/152 (0%)		0/151 (0%)		0/151 (0%)		0/148 (0%)		3/50 (6%)		1/50 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.