Evaluation of Boostrix™10 Years After Previous Booster Vaccination

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01147900
• Collaborator: (none)
• Enrollment: 180
• Locations: 3
• Arms: 3
• Duration (Months): 22.8
• Patients Per Site: 60
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Tetanus; Diphtheria	Biological: Boostrix™; Biological: Boostrix™-US formulation	Phase 4

Detailed Description

All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination
• Study Start Date: Jun 15, 2010
• Actual Primary Completion Date: May 8, 2012
• Actual Study Completion Date: May 8, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boostrix-REF Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Biological: Boostrix™; Intramuscular, single dose
Experimental: Boostrix-US Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Biological: Boostrix™-US formulation; Intramuscular, single dose
Experimental: Boostrix-INV Group Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Biological: Boostrix™; Intramuscular, single dose

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects Against Diphtheria and Tetanus [At Year 8.5]

   A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

2. Concentrations for Anti-D and Anti-T Antibodies. [At Year 8.5]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

3. Number of Seroprotected Subjects Against Diphtheria and Tetanus. [At Year 10]

   A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

4. Concentrations for Anti-D and Anti-T Antibodies. [At Year 10]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

5. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies. [At Year 8.5]

   A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

6. Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies. [At Year 8.5]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.

7. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [At Year 10]

   A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

8. Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [At Year 10]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

9. Number of Seroprotected Subjects Against Diphtheria and Tetanus [At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)]

   A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

10. Concentrations for Anti-D and Anti-T Antibodies. [At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

11. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)]

    A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).

12. Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. [At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)]

    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

13. Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens. [At 1 month post Year 10 booster vaccination]

    A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.

Secondary Outcome Measures

1. Number of Subjects With Any Solicited Local Symptoms. [During the 4-day (Days 0-3) follow-up period after booster vaccination]

   Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.

2. Number of Subjects With Any Solicited General Symptoms. [During the 4-day (Days 0-3) follow-up period after booster vaccination]

   Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.

3. Number of Subjects With Any Unsolicited Adverse Events (AEs). [During the 31-day (Days 0-30) follow-up period after booster vaccination]

   An unsolicited AE is any AE (i.e. any 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) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

4. Number of Subjects With Any Serious Adverse Events (SAEs). [At Year 8.5]

   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..

5. Number of Subjects With Any Serious Adverse Events (SAEs). [From Year 8.5 up to study end (one month post Year 10 booster vaccination)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 28 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.

• Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.

• Healthy subjects as established by medical history and clinical examination.

• Female subjects of non-childbearing potential may receive the booster vaccine.

• Female subjects of childbearing potential may receive the booster vaccine, if the subject:

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

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

• agrees to continue adequate contraception during the entire booster epoch.

Exclusion Criteria:

Exclusion criteria to be checked at study entry:

• Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.

• History of diphtheria, tetanus, or laboratory confirmed pertussis disease.

• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.

• Occurrence of any of the following adverse event after a previous administration of a

DTP vaccine :

• hypersensitivity reaction to any component of the vaccine,

• encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,

• fever >= 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause,

• collapse or shock-like state within 48 hours of vaccination,

• convulsions with or without fever, occurring within three days of vaccination.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Additional exclusion criteria to be checked for subjects before the booster vaccination administration:

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

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.

• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

• Pregnant or lactating female.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bruxelles		Belgium	1200
2	GSK Investigational Site	Leuven		Belgium	3000
3	GSK Investigational Site	Wilrijk		Belgium	2610

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: NCT01147900
• Other Study ID Numbers: 113055
• First Posted: Jun 22, 2010
• Last Update Posted: Aug 20, 2018
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Immune persistence; Boostrix; dTpa booster study
• Additional relevant MeSH terms: Diphtheria

Study Results

Participant Flow

Recruitment Details	Subjects consisted of those previously vaccinated & boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 [10 years post BST in GSK263855/029 study] + one month).
Pre-assignment Detail	At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Period Title: At Year 8.5
STARTED	54	60	66
COMPLETED	54	60	66
NOT COMPLETED	0	0	0
Period Title: At Year 8.5
STARTED	55	60	62
COMPLETED	55	59	62
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group	Total
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Total of all reporting groups
Overall Participants	55	60	66	181
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	22.4 (1.46)	22.3 (1.20)	22.3 (1.17)	22.3 (1.18)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	23.5 (1.44)	23.4 (1.21)	23.3 (1.17)	23.4 (1.19)
Sex: Female, Male (Count of Participants)
Female	29 52.7%	33 55%	39 59.1%	101 55.8%
Male	25 45.5%	27 45%	27 40.9%	79 43.6%
Sex: Female, Male (Count of Participants)
Female	29 52.7%	31 51.7%	36 54.5%	96 53%
Male	26 47.3%	29 48.3%	26 39.4%	81 44.8%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria and Tetanus
Description	A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame	At Year 8.5

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	65
Anti-D	53 96.4%	59 98.3%	65 98.5%
Anti-T	54 98.2%	59 98.3%	65 98.5%

2. Primary Outcome

Title	Concentrations for Anti-D and Anti-T Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time Frame	At Year 8.5

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	65
Anti-D	0.912	1.205	0.872
Anti-T	1.889	1.991	1.846

3. Primary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria and Tetanus.
Description	A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame	At Year 10

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	60	61
Anti-D	53 96.4%	60 100%	61 92.4%
Anti-T	54 98.2%	60 100%	61 92.4%

4. Primary Outcome

Title	Concentrations for Anti-D and Anti-T Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame	At Year 10

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	60	61
Anti-D	0.767	1.099	0.681
Anti-T	2.008	2.009	1.760

5. Primary Outcome

Title	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Description	A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At Year 8.5

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	65
Anti-PT [N=54;59;65]	42 76.4%	48 80%	60 90.9%
Anti-FHA [N=54;59;62]	54 98.2%	59 98.3%	62 93.9%
Anti-PRN [N=54;59;65]	54 98.2%	59 98.3%	65 98.5%

6. Primary Outcome

Title	Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Time Frame	At Year 8.5

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	65
Anti-PT [N=54;59;65]	10.933	13.372	18.034
Anti-FHA [N=54;59;62]	72.653	96.144	102.604
Anti-PRN [N=54;59;65]	161.349	179.027	134.616

7. Primary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description	A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At Year 10

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	60	60
Anti-PT [N=52;59;59]	44 80%	49 81.7%	51 77.3%
Anti-PRN [N=54;60;60]	54 98.2%	60 100%	60 90.9%
Anti-FHA [N=54;60;60]	54 98.2%	60 100%	60 90.9%

8. Primary Outcome

Title	Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time Frame	At Year 10

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	60	60
Anti-PT [N=52;59;59]	11.627	13.987	15.728
Anti-PRN [N=54;60;60]	131.814	158.239	115.209
Anti-FHA [N=54;60;60]	75.574	98.182	98.441

9. Primary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria and Tetanus
Description	A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame	At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	60
Anti-D, PRE	53 96.4%	59 98.3%	60 90.9%
Anti-D, POST	54 98.2%	59 98.3%	60 90.9%
Anti-T, PRE	54 98.2%	59 98.3%	60 90.9%
Anti-T, POST	54 98.2%	59 98.3%	60 90.9%

10. Primary Outcome

Title	Concentrations for Anti-D and Anti-T Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time Frame	At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	60
Anti-D, PRE	0.767	1.094	0.686
Anti-D, POST	4.251	5.226	4.150
Anti-T, PRE	2.008	1.987	1.752
Anti-T, POST	7.581	8.456	8.792

11. Primary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description	A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Time Frame	At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	60
Anti-PT, PRE [N=52;58;58]	44 80%	48 80%	50 75.8%
Anti-PT, POST [N=54;59;60]	54 98.2%	59 98.3%	60 90.9%
Anti-PRN, PRE [N=54;59;59]	54 98.2%	59 98.3%	59 89.4%
Anti-PRN, POST [N=53;59;60]	53 96.4%	59 98.3%	60 90.9%
Anti-FHA, PRE [N=54;59;59]	54 98.2%	59 98.3%	59 89.4%
Anti-FHA, POST [N=53;59;60]	53 96.4%	59 98.3%	60 90.9%

12. Primary Outcome

Title	Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time Frame	At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	60
Anti-PT, PRE [N=52;58;58]	11.627	14.193	15.650
Anti-PT, POST [N=54;59;60]	82.478	108.094	123.964
Anti-PRN, PRE [N=54;59;59]	131.814	161.903	114.226
Anti-PRN, POST [N=53;59;60]	445.751	448.475	448.839
Anti-FHA, PRE [N=54;59;59]	75.574	96.098	97.698
Anti-FHA, POST [N=53;59;60]	503.532	592.177	558.648

13. Primary Outcome

Title	Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Description	A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.
Time Frame	At 1 month post Year 10 booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	46	52	52
Booster responses to anti-PT [N=44;51;51]	44 80%	51 85%	48 72.7%
Booster responses to anti-PRN [N=45;52;52]	23 41.8%	29 48.3%	35 53%
Booster responses to anti-FHA [N=46;52;50]	43 78.2%	47 78.3%	48 72.7%

14. Secondary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms.
Description	Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	55	59	62
Any Pain	50 90.9%	55 91.7%	54 81.8%
Any Redness	23 41.8%	23 38.3%	21 31.8%
Any Swelling	21 38.2%	20 33.3%	19 28.8%

15. Secondary Outcome

Title	Number of Subjects With Any Solicited General Symptoms.
Description	Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	59	62
Any Fatigue	17	20	22
Any Gastrointestinal Symptoms	10	9	13
Any Headache	13	19	13
Any Fever	1	1	1

16. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE is any AE (i.e. any 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) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Time Frame	During the 31-day (Days 0-30) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	55	60	62
Count of Participants [Participants]	22 40%	16 26.7%	21 31.8%

17. Secondary Outcome

Title	Number of Subjects With Any 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..
Time Frame	At Year 8.5

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	54	60	66
Count of Participants [Participants]	0 0%	0 0%	0 0%

18. Secondary Outcome

Title	Number of Subjects With Any 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.
Time Frame	From Year 8.5 up to study end (one month post Year 10 booster vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

Arm/Group Title	Boostrix-US Group	Boostrix-INV Group	Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Measure Participants	55	60	62
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Adverse Event Reporting Description	Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, & Year 10 for the other groups.
Arm/Group Title	Boostrix-US Group		Boostrix-INV Group		Boostrix-REF Group
Arm/Group Description	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.		Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.		Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
All Cause Mortality
	Boostrix-US Group		Boostrix-INV Group		Boostrix-REF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Boostrix-US Group		Boostrix-INV Group		Boostrix-REF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/60 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Boostrix-US Group		Boostrix-INV Group		Boostrix-REF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/55 (96.4%)		58/60 (96.7%)		58/62 (93.5%)
General disorders
Pain	50/55 (90.9%)		55/59 (93.2%)		54/62 (87.1%)
Redness	23/55 (41.8%)		23/59 (39%)		21/62 (33.9%)
Swelling	21/55 (38.2%)		20/59 (33.9%)		19/62 (30.6%)
Fatigue	17/54 (31.5%)		20/59 (33.9%)		22/62 (35.5%)
Gastrointestinal symptoms	10/54 (18.5%)		9/59 (15.3%)		13/62 (21%)
Headache	13/54 (24.1%)		19/59 (32.2%)		13/62 (21%)
Infections and infestations
Nasopharyngitis	6/55 (10.9%)		1/60 (1.7%)		4/62 (6.5%)
Nervous system disorders
Headache	5/55 (9.1%)		1/60 (1.7%)		3/62 (4.8%)

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.