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Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343915
Recruitment Status : Completed
First Posted : June 23, 2006
Results First Posted : March 31, 2009
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hepatitis B
Interventions Biological: Engerix™-B (thiomersal-free) 20µg
Biological: 10 μg Engerix™-B (preservative-free)
Biological: placebo
Enrollment 267
Recruitment Details All subjects who participated in the primary vaccination study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up were contacted by the investigators. No additional subjects were recruited during this long-term follow-up study.
Pre-assignment Details  
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Period Title: Primary Study
Started 258 126
Completed 254 123
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             3
Other             1             0
Period Title: Month 30 Follow-up
Started 179 [1] 88
Completed 179 88
Not Completed 0 0
[1]
Subjects, previously vaccinated, that returned for the Month 30 follow-up.
Period Title: Month 42 Follow-up
Started 174 [1] 84
Completed 174 84
Not Completed 0 0
[1]
Subjects, previously vaccinated, that returned for the Month 42 follow-up.
Period Title: Month 54 Follow-up
Started 166 [1] 79
Completed 166 79
Not Completed 0 0
[1]
Subjects, previously vaccinated, that returned for the Month 54 follow-up.
Period Title: Month 66 Follow-up
Started 158 [1] 76
Completed 158 76
Not Completed 0 0
[1]
Subjects, previously vaccinated, that returned for the Month 66 follow-up.
Arm/Group Title 2-dose Engerix 3-dose Engerix Total
Hide Arm/Group Description subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively. Total of all reporting groups
Overall Number of Baseline Participants 258 126 384
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 126 participants 384 participants
12.9  (1.23) 12.7  (1.32) 12.8  (1.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 126 participants 384 participants
Female
132
  51.2%
61
  48.4%
193
  50.3%
Male
126
  48.8%
65
  51.6%
191
  49.7%
1.Primary Outcome
Title Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Hide Description A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 241 113
Measure Type: Number
Unit of Measure: Subjects
233 111
2.Primary Outcome
Title Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Hide Description A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame At Month 30, Month 42, Month 54 and Month 66
Hide Outcome Measure Data
Hide Analysis Population Description
Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 166 80
Measure Type: Number
Unit of Measure: Subjects
Month 30 (N=140, 64) 122 62
Month 42 (N=166, 80) 139 74
Month 54 (N=147, 76) 124 72
Month 66 (N=132, 70) 105 64
3.Primary Outcome
Title Antibody Titers Against Hepatitis-B Virus.
Hide Description Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time Frame At Month 30, Month 42, Month 54 and Month 66
Hide Outcome Measure Data
Hide Analysis Population Description
Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
Overall Number of Participants Analyzed 166 80
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Month 30 (N=140, 64)
229.0
(162.1 to 323.5)
708.3
(409.6 to 1224.8)
Month 42 (N=166, 80)
159.7
(118.3 to 215.7)
417.9
(267.3 to 653.6)
Month 54 (N=147, 76)
123.6
(92.7 to 165.0)
277.6
(176.5 to 436.7)
Month 66 (N=132, 70)
82.1
(60.7 to 111.0)
225.2
(142.6 to 355.9)
4.Secondary Outcome
Title Antibody Titers Against Hepatitis-B Virus.
Hide Description Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time Frame At Months 1, 2, 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 241 113
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Month 1 (N=240, 112)
28.8
(16.8 to 49.2)
28.7
(9.4 to 87.8)
Month 2 (N=240, 113)
17.6
(11.1 to 27.8)
29.4
(21.6 to 40.1)
Month 6 (N=239, 113)
18.8
(14.7 to 24.1)
90.0
(68.6 to 117.9)
Month 7 (N=241, 113)
2738.5
(2071.4 to 3620.5)
7238.3
(5247.3 to 9984.7)
5.Secondary Outcome
Title Number of Subjects Seroprotected for Anti-HBs Antibody.
Hide Description A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame At Months 1, 2 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 240 113
Measure Type: Number
Unit of Measure: Subjects
Month 1 (N=240, 112) 31 8
Month 2 (N=240, 113) 27 63
Month 6 (N=239, 113) 63 99
6.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 253 121
Measure Type: Number
Unit of Measure: Subjects
Any Pain; Dose 1 (N=253, 121) 121 44
Grade 3 Pain; Dose 1 (N=253, 121) 6 3
Any Redness; Dose 1 (N=253, 121) 30 10
Grade 3 Redness; Dose 1 (N=253, 121) 0 1
Any Swelling; Dose 1 (N=253, 121) 18 8
Grade 3 Swelling; Dose 1 (N=253, 121) 2 2
Any Pain; Dose 2 (N=252, 119) 42 38
Grade 3 Pain; Dose 2 (N=252, 119) 3 2
Any Redness; Dose 2 (N=252, 119) 15 15
Grade 3 Redness; Dose 2 (N=252, 119) 1 0
Any Swelling; Dose 2 (N=252, 119) 8 5
Grade 3 Swelling; Dose 2 (N=252, 119) 1 0
Any Pain; Dose 3 (N=250, 118) 106 35
Grade 3 Pain; Dose 3 (N=250, 118) 4 1
Any Redness; Dose 3 (N=250, 118) 29 11
Grade 3 Redness; Dose 3 (N=250, 118) 0 0
Any Swelling; Dose 3 (N=250, 118) 14 6
Grade 3 Swelling; Dose 3 (N=250, 118) 0 0
Any Pain; Across Doses (N=253, 121) 155 74
Grade 3 Pain; Across Doses (N=253, 121) 8 6
Any Redness; Across Doses (N=253, 121) 50 28
Grade 3 Redness; Across Doses (N=253, 121) 0 1
Any Swelling; Across Doses (N=253, 121) 27 15
Grade 3 Swelling; Across Doses (N=253, 121) 2 2
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Hide Description Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time Frame During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 253 121
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue; Dose 1 (N=253, 121) 50 26
Grade 3 Fatigue; Dose 1 (N=253, 121) 1 1
Related Fatigue; Dose 1 (N=253, 121) 29 16
Any Gastrointestinal; Dose 1 (N=253, 121) 26 4
Grade 3 Gastrointestinal; Dose 1 (N=253, 121) 3 0
Related Gastrointestinal; Dose 1 (N=253, 121) 11 3
Any Headache; Dose 1 (N=253, 121) 57 29
Grade 3 Headache; Dose 1 (N=253, 121) 0 1
Related Headache; Dose 1 (N=253, 121) 33 15
Any Temperature; Dose 1 (N=253, 121) 4 2
Grade 3 Temperature; Dose 1 (N=253, 121) 0 0
Related Temperature; Dose 1 (N=253, 121) 3 2
Any Fatigue; Dose 2 (N=252, 119) 37 18
Grade 3 Fatigue; Dose 2 (N=252, 119) 2 0
Related Fatigue; Dose 2 (N=252, 119) 23 13
Any Gastrointestinal; Dose 2 (N=252, 119) 20 7
Grade 3 Gastrointestinal; Dose 2 (N=252, 119) 0 0
Related Gastrointestinal; Dose 2 (N=252, 119) 7 5
Any Headache; Dose 2 (N=252, 119) 40 21
Grade 3 Headache; Dose 2 (N=252, 119) 0 0
Related Headache; Dose 2 (N=252, 119) 24 11
Any Temperature; Dose 2 (N=252, 119) 5 5
Grade 3 Temperature; Dose 2 (N=252, 119) 1 0
Related Temperature; Dose 2 (N=252, 119) 5 4
Any Fatigue; Dose 3 (N=250, 118) 49 20
Grade 3 Fatigue; Dose 3 (N=250, 118) 3 2
Related Fatigue; Dose 3 (N=250, 118) 30 8
Any Gastrointestinal; Dose 3 (N=250, 118) 17 14
Grade 3 Gastrointestinal; Dose 3 (N=250, 118) 3 2
Related Gastrointestinal; Dose 3 (N=250, 118) 6 6
Any Headache; Dose 3 (N=250, 118) 36 20
Grade 3 Headache; Dose 3 (N=250, 118) 1 1
Related Headache; Dose 3 (N=250, 118) 22 12
Any Temperature; Dose 3 (N=250, 118) 13 9
Grade 3 Temperature; Dose 3 (N=250, 118) 1 0
Related Temperature; Dose 3 (N=250, 118) 7 5
Any Fatigue; Across Doses (N=253, 121) 77 46
Grade 3 Fatigue; Across Doses (N=253, 121) 4 3
Related Fatigue; Across Doses (N=253, 121) 51 30
Any Gastrointestinal; Across Doses (N=253, 121) 36 21
Grade 3 Gastrointestinal; Across Doses (N=253,121) 6 2
Related Gastrointestinal; Across Doses (N=253,121) 17 14
Any Headache; Across Doses (N=253, 121) 78 46
Grade 3 Headache; Across Doses (N=253, 121) 1 2
Related Headache; Across Doses (N=253, 121) 49 30
Any Temperature; Across Doses (N=253, 121) 17 14
Grade 3 Temperature; Across Doses (N=253, 121) 1 0
Related Temperature; Across Doses (N=253, 121) 10 10
8.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame During the 31-day (Day 0-30) follow-up period after each vaccination and overall
Hide Outcome Measure Data
Hide Analysis Population Description
Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
Overall Number of Participants Analyzed 257 125
Measure Type: Number
Unit of Measure: Subjects
any AE(s) 112 54
grade 3 AE(s) 31 15
related AE(s) 9 1
9.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame During the entire study period (Month 0 to Month 66)
Hide Outcome Measure Data
Hide Analysis Population Description
Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 257 125
Measure Type: Number
Unit of Measure: Subjects
4 1
10.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame At Month 30, Month 42, Month 54 & Month 66
Hide Outcome Measure Data
Hide Analysis Population Description
LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description:
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Overall Number of Participants Analyzed 179 88
Measure Type: Number
Unit of Measure: Participants
Month 30 (N=179, 88) 0 0
Month 42 (N=174, 84) 0 0
Month 54 (N=166, 79) 0 0
Month 66 (N=158, 76) 0 0
Time Frame Serious adverse events: during the entire study period (Month 0-66), Solicited local and general symptoms: During the 4-day (Days 0-3) post vaccination period and unsolicited adverse events: up to Month 7.Non-serious adverse events were not assessed during the long term follow-up period (Month 30-66). The total number of participants at risk is the number of participants with at least one documented dose.
Adverse Event Reporting Description For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE’s table.
 
Arm/Group Title 2-dose Engerix 3-dose Engerix
Hide Arm/Group Description subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month. subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
All-Cause Mortality
2-dose Engerix 3-dose Engerix
Affected / at Risk (%) Affected / at Risk (%)
Total   0/257 (0.00%)   0/125 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
2-dose Engerix 3-dose Engerix
Affected / at Risk (%) Affected / at Risk (%)
Total   4/257 (1.56%)   1/125 (0.80%) 
Gastrointestinal disorders     
Ileitis * 1  1/257 (0.39%)  0/125 (0.00%) 
Infections and infestations     
Arthritis * 1  1/257 (0.39%)  0/125 (0.00%) 
Infection bacterial * 1  1/257 (0.39%)  0/125 (0.00%) 
Injury, poisoning and procedural complications     
Injury * 1  1/257 (0.39%)  1/125 (0.80%) 
1
Term from vocabulary, WHO
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2-dose Engerix 3-dose Engerix
Affected / at Risk (%) Affected / at Risk (%)
Total   155/257 (60.31%)   74/125 (59.20%) 
Gastrointestinal disorders     
Gastrointestinal symptoms; Dose 1  1  26/253 (10.28%)  4/121 (3.31%) 
Gastrointestinal symptoms; Dose 2  1  20/252 (7.94%)  7/119 (5.88%) 
Gastrointestinal symptoms; Dose 3  1  17/250 (6.80%)  14/118 (11.86%) 
Gastrointestinal symptoms; Across Doses  1  36/253 (14.23%)  21/121 (17.36%) 
General disorders     
Pain; Dose 1  1  121/253 (47.83%)  44/121 (36.36%) 
Redness; Dose 1  1  30/253 (11.86%)  10/121 (8.26%) 
Swelling; Dose 1  1  18/253 (7.11%)  8/121 (6.61%) 
Pain; Dose 2  1  42/252 (16.67%)  38/119 (31.93%) 
Redness; Dose 2  1  15/252 (5.95%)  15/119 (12.61%) 
Pain; Dose 3  1  106/250 (42.40%)  35/118 (29.66%) 
Redness; Dose 3  1  29/250 (11.60%)  11/118 (9.32%) 
Swelling; Dose 3  1  14/250 (5.60%)  6/118 (5.08%) 
Pain; Across Doses  1  155/253 (61.26%)  74/121 (61.16%) 
Redness; Across Doses  1  50/253 (19.76%)  28/121 (23.14%) 
Swelling; Across Doses  1  27/253 (10.67%)  15/121 (12.40%) 
Fatigue; Dose 1  1  50/253 (19.76%)  26/121 (21.49%) 
Fatigue; Dose 2  1  37/252 (14.68%)  18/119 (15.13%) 
Fatigue; Dose 3  1  49/250 (19.60%)  20/118 (16.95%) 
Fever; Dose 3  1  13/250 (5.20%)  9/118 (7.63%) 
Fatigue; Across Doses  1  77/253 (30.43%)  46/121 (38.02%) 
Fever; Across Doses  1  17/253 (6.72%)  14/121 (11.57%) 
Infections and infestations     
Upper respiratory tract infection * 1  26/257 (10.12%)  22/125 (17.60%) 
Nervous system disorders     
Headache; Dose 1  1  57/253 (22.53%)  29/121 (23.97%) 
Headache; Dose 2  1  40/252 (15.87%)  21/119 (17.65%) 
Headache; Across Doses  1  78/253 (30.83%)  46/121 (38.02%) 
Headache * 1  28/257 (10.89%)  10/125 (8.00%) 
Headache; Dose 3  1  36/250 (14.40%)  20/118 (16.95%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngitis * 1  15/257 (5.84%)  5/125 (4.00%) 
1
Term from vocabulary, WHO
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343915     History of Changes
Obsolete Identifiers: NCT00787228
Other Study ID Numbers: 101695 Ext. Mth30
101696 ( Other Identifier: GSK )
101697 ( Other Identifier: GSK )
101698 ( Other Identifier: GSK )
2015-001531-20 ( EudraCT Number )
First Submitted: September 14, 2005
First Posted: June 23, 2006
Results First Submitted: December 23, 2008
Results First Posted: March 31, 2009
Last Update Posted: June 10, 2019