Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00979407
• Collaborator: (none)
• Enrollment: 336
• Locations: 7
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site: 48
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Influenza vaccine GSK2340272A; Biological: Influenza vaccine GSK2340274A	Phase 3

Detailed Description

This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 336 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Immunological Equivalence Between GSK2340272A and GSK2340274A Influenza Vaccines in Adults Aged 18 to 60 Years
• Actual Study Start Date: Oct 12, 2009
• Actual Primary Completion Date: Nov 9, 2009
• Actual Study Completion Date: Nov 4, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK2340272A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Biological: Influenza vaccine GSK2340272A; Two intramuscular injections at Day 0 and Day 21
Experimental: GSK2340274A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Biological: Influenza vaccine GSK2340274A; Two intramuscular injections at Day 0 and Day 21

Outcome Measures

Primary Outcome Measures

1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [At Day 21]

   Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.

Secondary Outcome Measures

1. Number of Seroconverted (SCR) Subjects for HI Antibodies [At Days 21 and 42]

   Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

2. Number of SCR Subjects for HI Antibodies [At Days 182 and 364]

   Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

3. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [At Days 0 and 42]

   Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

4. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [At Days 182 and 364]

   Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

5. Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [At Days 0, 21 and 42]

   A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

6. Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain [At Days 182 and 364]

   A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

7. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [At Days 21 and 42]

   GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

8. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease [At Days 182 and 364]

   GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

10. Number of Days With Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

11. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.

12. Number of Days With Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

13. Number of Subjects With Potential Immune-mediated Diseases (pIMDs) [From Day 0 up to Day 42]

    A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

14. Number of Subjects With pIMDs [During the entire study period (from Day 0 up to Day 364)]

    A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

15. Number of Subjects With Any Adverse Event of Special Interest (AESIs) [During the entire study period (from Day 0 up to Day 364)]

    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

16. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

17. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (from Day 0 up to Day 364)]

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject.

• Satisfactory baseline medical assessment by history and physical examination.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device

• Females of non-childbearing potential may be enrolled in the study.

• Female of childbearing potential may be enrolled in the study, if she:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of vaccination, and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.

• 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.

• Presence of an axillary temperature >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.

• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.

• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

• Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.

• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.

• An acute evolving neurological disorder or history of Guillain-Barré syndrome.

• Administration of any vaccines within 30 days before vaccination.

• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

• Pregnant or lactating female

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Caen cedex 9		France	14033
2	GSK Investigational Site	Paris Cedex 18		France	75877
3	GSK Investigational Site	Paris		France	75679
4	GSK Investigational Site	Poitiers		France	86000
5	GSK Investigational Site	Regensburg	Bayern	Germany	93053
6	GSK Investigational Site	Wuerzburg	Bayern	Germany	97070
7	GSK Investigational Site	Schmiedeberg	Sachsen	Germany	01762

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: NCT00979407
• Other Study ID Numbers: 113535
• First Posted: Sep 18, 2009
• Last Update Posted: Aug 6, 2018
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: influenza infection; GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

Participant Flow

Pre-assignment Detail	Out of 336 subjects enrolled in the study, 2 subjects did not receive any vaccination.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Period Title: Overall Study
STARTED	167	167
COMPLETED	161	160
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP	Total
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Total of all reporting groups
Overall Participants	167	167	334
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	40.1 (11.65)	39.7 (11.98)	39.90 (11.80)
Sex: Female, Male (Count of Participants)
Female	87 52.1%	77 46.1%	164 49.1%
Male	80 47.9%	90 53.9%	170 50.9%
Race/Ethnicity, Customized (Count of Participants)
African heritage / african american	2 1.2%	3 1.8%	5 1.5%
White - arabic / north african heritage	0 0%	3 1.8%	3 0.9%
White - caucasian / european heritage	165 98.8%	161 96.4%	326 97.6%

Outcome Measures

1. Primary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Description	Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received 1 vaccine dose and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	155	155
Geometric Mean (95% Confidence Interval) [Titers]	383.6	339.1

2. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for HI Antibodies
Description	Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time Frame	At Days 21 and 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	155	155
Flu A/CAL/7/09, Day 21	151 90.4%	145 86.8%
Flu A/CAL/7/09, Day 42	154 92.2%	153 91.6%

3. Secondary Outcome

Title	Number of SCR Subjects for HI Antibodies
Description	Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time Frame	At Days 182 and 364

Outcome Measure Data

Analysis Population Description

The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	156	154
Flu A/CAL/7/09, Day 182	144 86.2%	141 84.4%
Flu A/CAL/7/09, Day 364	109 65.3%	106 63.5%

4. Secondary Outcome

Title	Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Description	Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Time Frame	At Days 0 and 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	155	155
Flu A/CAL/7/09, Day 0	9.5	10.7
Flu A/CAL/7/09, Day 42	599.8	678.3

5. Secondary Outcome

Title	Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Description	Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Time Frame	At Days 182 and 364

Outcome Measure Data

Analysis Population Description

The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	156	154
Flu A/CAL/7/09, Day 182	202.5	233.0
Flu A/CAL/7/09, Day 364	96.7	107.6

6. Secondary Outcome

Title	Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Time Frame	At Days 0, 21 and 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	155	155
Flu A/CAL/7/09, Day 0	19 11.4%	22 13.2%
Flu A/CAL/7/09, Day 21	155 92.8%	151 90.4%
Flu A/CAL/7/09, Day 42	155 92.8%	155 92.8%

7. Secondary Outcome

Title	Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Time Frame	At Days 182 and 364

Outcome Measure Data

Analysis Population Description

The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	156	154
Flu A/CAL/7/09, Day 182	151 90.4%	150 89.8%
Flu A/CAL/7/09, Day 364	121 72.5%	121 72.5%

8. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Description	GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time Frame	At Days 21 and 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	155	155
Flu A/CAL/7/09, Day 21	40.3	31.6
Flu A/CAL/7/09, Day 42	63.0	63.2

9. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Description	GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time Frame	At Days 182 and 364

Outcome Measure Data

Analysis Population Description

The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	156	154
Flu A/CAL/7/09, Day 182	22.0	21.7
Flu A/CAL/7/09, Day 364	11.0	11.0

10. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Any Pain, Dose 1	148 88.6%	144 86.2%
Grade 3 Pain, Dose 1	6 3.6%	4 2.4%
Any Redness, Dose 1	25 15%	19 11.4%
Grade 3 Redness, Dose 1	0 0%	0 0%
Any Swelling, Dose 1	32 19.2%	29 17.4%
Grade 3 Swelling, Dose 1	2 1.2%	0 0%
Any Pain, Dose 2	139 83.2%	137 82%
Grade 3 Pain, Dose 2	5 3%	4 2.4%
Any Redness, Dose 2	18 10.8%	17 10.2%
Grade 3 Redness, Dose 2	0 0%	0 0%
Any Swelling, Dose 2	17 10.2%	21 12.6%
Grade 3 Swelling, Dose 2	1 0.6%	0 0%
Any Pain, Across doses	153 91.6%	151 90.4%
Grade 3 Pain, Across doses	8 4.8%	6 3.6%
Any Redness, Across doses	35 21%	28 16.8%
Grade 3 Redness, Across doses	0 0%	0 0%
Any Swelling, Across doses	36 21.6%	36 21.6%
Grade 3 Swelling, Across doses	2 1.2%	0 0%

11. Secondary Outcome

Title	Number of Days With Solicited Local Symptoms
Description	The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Measure Doses with the symptom	287	281
Pain, Post-Dose 1	3.0	3.0
Pain, Post-Dose 2	3.0	3.0
Pain, Overall/dose	3.0	3.0
Redness, Post-Dose 1	3.0	3.0
Redness, Post-Dose 2	3.0	2.0
Redness, Overall/dose	3.0	3.0
Swelling, Post-Dose 1	3.0	2.0
Swelling, Post-Dose 2	3.0	2.0
Swelling, Overall/dose	3.0	2.0

12. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Any Fatigue, Dose 1	60 35.9%	55 32.9%
Grade 3 Fatigue, Dose 1	3 1.8%	2 1.2%
Related Fatigue, Dose 1	54 32.3%	54 32.3%
Any Headache, Dose 1	55 32.9%	48 28.7%
Grade 3 Headache, Dose 1	4 2.4%	2 1.2%
Related Headache, Dose 1	46 27.5%	44 26.3%
Any Joint pain, Dose 1	37 22.2%	38 22.8%
Grade 3 Joint pain, Dose 1	1 0.6%	2 1.2%
Related Joint pain, Dose 1	33 19.8%	37 22.2%
Any Muscle aches, Dose 1	57 34.1%	81 48.5%
Grade 3 Muscle aches, Dose 1	3 1.8%	4 2.4%
Related Muscle aches, Dose 1	55 32.9%	79 47.3%
Any Shivering, Dose 1	34 20.4%	24 14.4%
Grade 3 Shivering, Dose 1	0 0%	2 1.2%
Related Shivering, Dose 1	32 19.2%	24 14.4%
Any Sweating, Dose 1	13 7.8%	14 8.4%
Grade 3 Sweating, Dose 1	1 0.6%	1 0.6%
Related Sweating, Dose 1	12 7.2%	14 8.4%
Any Temperature, Dose 1	2 1.2%	5 3%
Grade 3 Temperature, Dose 1	1 0.6%	2 1.2%
Related Temperature, Dose 1	2 1.2%	5 3%
Any Fatigue, Dose 2	61 36.5%	60 35.9%
Grade 3 Fatigue, Dose 2	3 1.8%	4 2.4%
Related Fatigue, Dose 2	59 35.3%	59 35.3%
Any Headache, Dose 2	57 34.1%	51 30.5%
Grade 3 Headache, Dose 2	2 1.2%	3 1.8%
Related Headache, Dose 2	53 31.7%	46 27.5%
Any Joint pain, Dose 2	34 20.4%	47 28.1%
Grade 3 Joint pain, Dose 2	5 3%	4 2.4%
Related Joint pain, Dose 2	33 19.8%	45 26.9%
Any Muscle aches, Dose 2	64 38.3%	71 42.5%
Grade 3 Muscle aches, Dose 2	4 2.4%	2 1.2%
Related Muscle aches, Dose 2	63 37.7%	70 41.9%
Any Shivering, Dose 2	37 22.2%	35 21%
Grade 3 Shivering, Dose 2	5 3%	4 2.4%
Related Shivering, Dose 2	37 22.2%	32 19.2%
Any Sweating, Dose 2	24 14.4%	16 9.6%
Grade 3 Sweating, Dose 2	4 2.4%	2 1.2%
Related Sweating, Dose 2	23 13.8%	15 9%
Any Temperature, Dose 2	11 6.6%	8 4.8%
Grade 3 Temperature, Dose 2	2 1.2%	3 1.8%
Related Temperature, Dose 2	11 6.6%	8 4.8%
Any Fatigue, Across doses	92 55.1%	79 47.3%
Grade 3 Fatigue, Across doses	6 3.6%	5 3%
Related Fatigue, Across doses	87 52.1%	78 46.7%
Any Headache, Across doses	83 49.7%	73 43.7%
Grade 3 Headache, Across doses	6 3.6%	5 3%
Related Headache, Across doses	74 44.3%	69 41.3%
Any Joint pain, Across doses	53 31.7%	66 39.5%
Grade 3 Joint pain, Across doses	5 3%	5 3%
Related Joint pain, Across doses	49 29.3%	64 38.3%
Any Muscle aches, Across doses	85 50.9%	104 62.3%
Grade 3 Muscle aches, Across doses	6 3.6%	5 3%
Related Muscle aches, Across doses	83 49.7%	102 61.1%
Any Shivering, Across doses	57 34.1%	47 28.1%
Grade 3 Shivering, Across doses	5 3%	6 3.6%
Related Shivering, Across doses	56 33.5%	45 26.9%
Any Sweating, Across doses	28 16.8%	28 16.8%
Grade 3 Sweating, Across doses	5 3%	3 1.8%
Related Sweating, Across doses	27 16.2%	27 16.2%
Any Temperature, Across doses	12 7.2%	11 6.6%
Grade 3 Temperature, Across doses	3 1.8%	5 3%
Related Temperature, Across doses	12 7.2%	11 6.6%

13. Secondary Outcome

Title	Number of Days With Solicited General Symptoms
Description	The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Measure Doses with the symptom	121	152
Fatigue, Post-Dose 1	2.0	2.0
Fatigue, Post-Dose 2	1.0	2.0
Fatigue, Overall/dose	2.0	2.0
Headache, Post-Dose 1	1.0	2.0
Headache, Post-Dose 2	1.0	2.0
Headache, Overall/dose	1.0	2.0
Joint pain, Post-Dose 1	2.0	2.0
Joint pain, Post-Dose 2	2.0	2.0
Joint pain, Overall/dose	2.0	2.0
Muscle aches, Post-Dose 1	2.0	2.0
Muscle aches, Post-Dose 2	2.0	2.0
Muscle aches, Overall/dose	2.0	2.0
Sweating, Post-Dose 1	1.0	1.0
Sweating, Post-Dose 2	1.0	1.0
Sweating, Overall/dose	1.0	1.0
Shivering, Post-Dose 1	1.0	1.0
Shivering, Post-Dose 2	1.0	1.0
Shivering, Overall/dose	1.0	1.0
Temperature, Post-Dose 1	3.0	1.0
Temperature, Post-Dose 2	1.0	2.0
Temperature, Overall/dose	1.0	1.0

14. Secondary Outcome

Title	Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Description	A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time Frame	From Day 0 up to Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Count of Participants [Participants]	0 0%	0 0%

15. Secondary Outcome

Title	Number of Subjects With pIMDs
Description	A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time Frame	During the entire study period (from Day 0 up to Day 364)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Count of Participants [Participants]	1 0.6%	0 0%

16. Secondary Outcome

Title	Number of Subjects With Any Adverse Event of Special Interest (AESIs)
Description	An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time Frame	During the entire study period (from Day 0 up to Day 364)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340274A GROUP	GSK2340272A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Count of Participants [Participants]	0 0%	0 0%

17. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame	Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Any AE(s), Days 0-20	37 22.2%	31 18.6%
Grade 3 AE(s), Days 0-20	3 1.8%	1 0.6%
Related AE(s), Days 0-20	17 10.2%	11 6.6%
Any AE(s), up to Day 84	68 40.7%	71 42.5%
Grade 3 AE(s), up to Day 84	16 9.6%	8 4.8%
Related AE(s), up to Day 84	20 12%	20 12%

18. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the entire study period (from Day 0 up to Day 364)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.

Arm/Group Title	GSK2340272A GROUP	GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Measure Participants	167	167
Count of Participants [Participants]	9 5.4%	11 6.6%

Adverse Events

Time Frame	Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).
Arm/Group Title	GSK2340272A GROUP		GSK2340274A GROUP
Arm/Group Description	Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.		Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
All Cause Mortality
	GSK2340272A GROUP		GSK2340274A GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/167 (0%)
Serious Adverse Events
	GSK2340272A GROUP		GSK2340274A GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/167 (5.4%)		11/167 (6.6%)
Cardiac disorders
Acute coronary syndrome	1/167 (0.6%)	1	0/167 (0%)	0
Endocrine disorders
Thyroid mass	1/167 (0.6%)	1	0/167 (0%)	0
Gastrointestinal disorders
Anal fissure	0/167 (0%)	0	1/167 (0.6%)	1
Gastritis	0/167 (0%)	0	1/167 (0.6%)	1
Inguinal hernia	1/167 (0.6%)	1	0/167 (0%)	0
Infections and infestations
Appendicitis	0/167 (0%)	0	1/167 (0.6%)	1
Perirectal abscess	0/167 (0%)	0	1/167 (0.6%)	1
Pyelonephritis	0/167 (0%)	0	1/167 (0.6%)	1
Injury, poisoning and procedural complications
Foot fracture	0/167 (0%)	0	1/167 (0.6%)	1
Intervertebral disc injury	1/167 (0.6%)	1	0/167 (0%)	0
Testicular injury	1/167 (0.6%)	1	0/167 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	1/167 (0.6%)	1	0/167 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/167 (0%)	0	1/167 (0.6%)	1
Intervertebral disc protrusion	0/167 (0%)	0	1/167 (0.6%)	1
Nervous system disorders
Amnesia	0/167 (0%)	0	1/167 (0.6%)	1
Pregnancy, puerperium and perinatal conditions
Abortion missed	0/167 (0%)	0	1/167 (0.6%)	1
Abortion spontaneous incomplete	1/167 (0.6%)	1	0/167 (0%)	0
Psychiatric disorders
Adjustment disorder	1/167 (0.6%)	1	0/167 (0%)	0
Suicide attempt	1/167 (0.6%)	1	0/167 (0%)	0
Renal and urinary disorders
Nephrolithiasis	1/167 (0.6%)	1	1/167 (0.6%)	1
Reproductive system and breast disorders
Ovarian cyst	1/167 (0.6%)	1	0/167 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/167 (0.6%)	1	0/167 (0%)	0
Pulmonary embolism	0/167 (0%)	0	1/167 (0.6%)	1
Sleep apnoea syndrome	1/167 (0.6%)	1	0/167 (0%)	0
Other (Not Including Serious) Adverse Events
	GSK2340272A GROUP		GSK2340274A GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	157/167 (94%)		159/167 (95.2%)
General disorders
Chills	57/167 (34.1%)	71	47/167 (28.1%)	59
Fatigue	92/167 (55.1%)	121	79/167 (47.3%)	116
Pain	153/167 (91.6%)	287	151/167 (90.4%)	281
Pyrexia	12/167 (7.2%)	14	10/167 (6%)	11
Swelling	36/167 (21.6%)	49	36/167 (21.6%)	50
Infections and infestations
Nasopharyngitis	13/167 (7.8%)	15	9/167 (5.4%)	9
Rhinitis	9/167 (5.4%)	9	4/167 (2.4%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	53/167 (31.7%)	71	66/167 (39.5%)	85
Myalgia	85/167 (50.9%)	121	104/167 (62.3%)	152
Nervous system disorders
Headache	83/167 (49.7%)	120	80/167 (47.9%)	116
Skin and subcutaneous tissue disorders
Erythema	35/167 (21%)	43	28/167 (16.8%)	36
Hyperhidrosis	28/167 (16.8%)	37	28/167 (16.8%)	30

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.