Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00693706
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Duration (Months): 9.8
• Patients Per Site: 100
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Trivalent influenza vaccine GSK 138842A; Biological: Fluarix	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
• Study Start Date: Jun 2, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 26, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Trivalent influenza vaccine GSK 138842A; IM injection on Day 0
Active Comparator: Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Biological: Fluarix; IM injection on Day 0

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Solicited Local Symptoms. [During the 7-day (Days 0-6) post vaccination period]

   Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

2. Number of Subjects With Solicited General Symptoms. [During the 7-day (Days 0-6) post vaccination period]

   Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.

3. Number of Subjects With Medically Attended Adverse Events (MAEs). [During the entire study period (Days 0-182)]

   Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.

4. Number of Subjects With New Onset of Chronic Diseases (NOCDs). [During the entire study period (Days 0-182)]

   NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

5. Number of Subjects With Unsolicited Adverse Events (AEs). [During the 90-day (Days 0-89) post-vaccination period]

   Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

6. Number of Subjects With Serious Adverse Events (SAEs). [During the entire study period (Days 0-182)]

   Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.

7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. [At Day 21]

   Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

8. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [At Day 21]

   A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

9. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [At Day 21]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

10. Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. [At Day 0 and Day 21]

    GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination

• Access to a telephone for scheduled follow-up telephone contacts

• Ability to provide written informed consent

• Healthy subjects as established by medical history and physical examination before entering into the study

• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion Criteria:

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

• Receipt of systemic glucocorticoids within 30 days of study enrollment

• Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period

• Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period

• Previous vaccination against influenza (2007-2008 influenza season)

• History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient

• History of Guillain-Barre Syndrome (GBS)

• Acute disease, febrile illness, or upper respiratory infection at screening.

• History of splenectomy

• Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination

• Acquired or congenital coagulation disorders or known thrombocytopenia

• Current treatment with warfarin or heparin derivatives

• Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events

• Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Miami	Florida	United States	33143
2	GSK Investigational Site	Lenexa	Kansas	United States	66219

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: NCT00693706
• Other Study ID Numbers: 110127
• First Posted: Jun 9, 2008
• Last Update Posted: Jun 8, 2018
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: cell culture; Safety; Influenza; Humans; Adults; Immunogenicity; Influenza vaccine; Vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
STARTED	101	99
COMPLETED	101	98
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	GSK 1388442A Group	Fluarix Group	Total
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Total of all reporting groups
Overall Participants	101	99	200
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	33.1 (10.24)	31.6 (9.77)	32.4 (10.0)
Sex: Female, Male (Count of Participants)
Female	54 53.5%	52 52.5%	106 53%
Male	47 46.5%	47 47.5%	94 47%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Solicited Local Symptoms.
Description	Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Time Frame	During the 7-day (Days 0-6) post vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	101	99
Pain	48	48
Redness	1	0
Swelling	1	0

2. Primary Outcome

Title	Number of Subjects With Solicited General Symptoms.
Description	Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Time Frame	During the 7-day (Days 0-6) post vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	100	99
Arthralgia	2	4
Fatigue	19	15
Headache	24	21
Muscle aches	15	17
Shivering	3	2
Temperature ≥ 38.0°C	1	0

3. Primary Outcome

Title	Number of Subjects With Medically Attended Adverse Events (MAEs).
Description	Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
Time Frame	During the entire study period (Days 0-182)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	101	99
Number [subjects]	4	7

4. Primary Outcome

Title	Number of Subjects With New Onset of Chronic Diseases (NOCDs).
Description	NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Time Frame	During the entire study period (Days 0-182)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	101	99
Number [subjects]	0	0

5. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs).
Description	Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Time Frame	During the 90-day (Days 0-89) post-vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	101	99
Number [subjects]	28	21

6. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs).
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Time Frame	During the entire study period (Days 0-182)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	101	99
Number [subjects]	1	0

7. Primary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.
Description	Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame	At Day 21

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 data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	100	98
H1N1	183.7	501.4
H3N2	333.5	315.5
MALAY.	316.6	326.8

8. Primary Outcome

Title	Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Description	A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame	At Day 21

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 data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	100	98
H1N1	90	97
H3N2	98	98
MALAY.	99	96

9. Primary Outcome

Title	Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame	At Day 21

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 data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	100	98
H1N1	72	79
H3N2	68	66
MALAY.	74	67

10. Primary Outcome

Title	Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
Description	GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
Time Frame	At Day 0 and Day 21

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 data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Arm/Group Title	GSK 1388442A Group	Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants	100	98
H1N1	10.9	17.8
H3N2	10.1	7.5
MALAY.	12.3	10.5

Adverse Events

Time Frame	SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.
Arm/Group Title	GSK 1388442A Group		Fluarix Group
Arm/Group Description	Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.		Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
All Cause Mortality
	GSK 1388442A Group		Fluarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GSK 1388442A Group		Fluarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/101 (1%)		0/99 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/101 (1%)		0/99 (0%)
Other (Not Including Serious) Adverse Events
	GSK 1388442A Group		Fluarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	64/101 (63.4%)		63/99 (63.6%)
General disorders
Pain	48/101 (47.5%)		48/99 (48.5%)
Fatigue	19/100 (19%)		15/99 (15.2%)
Headache	24/100 (24%)		21/99 (21.2%)
Muscle aches	15/100 (15%)		17/99 (17.2%)

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.