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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults

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: NCT01738477
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : December 27, 2017
Last Update Posted : June 6, 2018
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
Conditions Tetanus
Acellular Pertussis
Diphtheria
Intervention Biological: Boostrix
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study. Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Period Title: Overall Study
Started 37 128
Completed 36 124
Not Completed 1 4
Reason Not Completed
Lost to Follow-up             1             4
Arm/Group Title Boostrix Group 1 Boostrix Group 2 Total
Hide Arm/Group Description Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study. Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study. Total of all reporting groups
Overall Number of Baseline Participants 37 128 165
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 128 participants 165 participants
23.3  (2.4) 23.5  (2.1) 23.5  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 128 participants 165 participants
Female
18
  48.6%
57
  44.5%
75
  45.5%
Male
19
  51.4%
71
  55.5%
90
  54.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 128 participants 165 participants
Black
1
   2.7%
6
   4.7%
7
   4.2%
Oriental
0
   0.0%
1
   0.8%
1
   0.6%
Other
5
  13.5%
7
   5.5%
12
   7.3%
White/caucasian
31
  83.8%
114
  89.1%
145
  87.9%
1.Primary Outcome
Title Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Hide Description A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
35
 100.0%
115
 100.0%
Anti-T
35
 100.0%
115
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Boostrix Group 1, Boostrix Group 2
Comments Non-inferiority in terms of seroprotection rates to diphtheria.
Type of Statistical Test Non-Inferiority
Comments To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval 95%
-3.25 to 9.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boostrix Group 1, Boostrix Group 2
Comments Non-inferiority in terms of seroprotection rates to tetanus.
Type of Statistical Test Non-Inferiority
Comments To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval 95%
-3.25 to 9.95
Estimation Comments [Not Specified]
2.Primary Outcome
Title Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Hide Description Concentrations were expressed in geometric mean concentrations (GMCs).
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
anti-PT
66.2
(50.8 to 86.2)
87.3
(74.5 to 102.4)
anti-FHA
336.2
(250.0 to 452.2)
290.5
(252.5 to 334.2)
anti-PRN
425.5
(281.9 to 642.3)
463.3
(390.8 to 549.3)
3.Secondary Outcome
Title Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Hide Description A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
35
 100.0%
115
 100.0%
Anti-T
35
 100.0%
115
 100.0%
4.Secondary Outcome
Title Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.
Hide Description The cut-off of the assay was ≥ 1.0 IU/mL.
Time Frame At Month 0 and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D at Month 0
23
  65.7%
70
  60.9%
Anti-D at Month 1
34
  97.1%
115
 100.0%
Anti-T at Month 0
27
  77.1%
86
  74.8%
Anti-T at Month 1
35
 100.0%
115
 100.0%
5.Secondary Outcome
Title Anti-D and Anti-T Antibody Concentrations.
Hide Description Concentrations were expressed as GMCs.
Time Frame At Month 0 and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D at Month 0
1.6
(1.1 to 2.3)
1.6
(1.3 to 2.1)
Anti-D at Month 1
6.8
(5.4 to 8.6)
6.0
(5.3 to 6.9)
Anti-T at Month 0
1.8
(1.4 to 2.4)
1.8
(1.5 to 2.2)
Anti-T at Month 1
9.9
(7.9 to 12.5)
9.7
(8.5 to 11.0)
6.Secondary Outcome
Title Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Hide Description Concentrations were expressed in geometric mean concentrations (GMCs).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
anti-PT
5.3
(3.4 to 8.2)
9.9
(8.1 to 12.2)
anti-FHA
21.7
(13.4 to 35.4)
36.9
(31.5 to 43.3)
anti-PRN
27.8
(13.7 to 56.3)
71.6
(56.7 to 90.6)
7.Secondary Outcome
Title Number of Subjects With a Booster Response to Anti-D and Anti-T.
Hide Description

Booster response to anti-D and anti-T antigens was defined as:

  • for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,
  • for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
14
  40.0%
47
  40.9%
Anti-T
21
  60.0%
64
  55.7%
8.Secondary Outcome
Title Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Hide Description

Booster response to pertussis antigens was defined as:

  • for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;
  • for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;
  • for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.
Time Frame At Month 1.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Number of Participants Analyzed 35 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT
33
  94.3%
106
  92.2%
Anti-FHA
34
  97.1%
104
  90.4%
Anti-PRN
29
  82.9%
79
  68.7%
9.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.
Time Frame During the 4 days (Day 0 - 3) follow-up period after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Overall Number of Participants Analyzed 36 125
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
21
  58.3%
97
  77.6%
Any Redness
15
  41.7%
47
  37.6%
Any Swelling
7
  19.4%
30
  24.0%
10.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.
Time Frame During the 4 days (Day 0 - 3) follow-up period after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Overall Number of Participants Analyzed 36 125
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
8
  22.2%
38
  30.4%
Any Gastrointestinal Symptoms
1
   2.8%
11
   8.8%
Any Headache
8
  22.2%
40
  32.0%
Any Fever
1
   2.8%
3
   2.4%
11.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame During the 31 days (Day 0 - 30) after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Overall Number of Participants Analyzed 37 128
Measure Type: Count of Participants
Unit of Measure: Participants
10
  27.0%
33
  25.8%
12.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 to 31 days post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description:
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix™ in this study.
Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix™ in this study.
Overall Number of Participants Analyzed 37 128
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boostrix Group 1 Boostrix Group 2
Hide Arm/Group Description Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study. Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
All-Cause Mortality
Boostrix Group 1 Boostrix Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)      0/128 (0.00%)    
Hide Serious Adverse Events
Boostrix Group 1 Boostrix Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/128 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boostrix Group 1 Boostrix Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/37 (81.08%)      107/128 (83.59%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  1/37 (2.70%)  1 11/128 (8.59%)  11
General disorders     
Fatigue  1  8/37 (21.62%)  8 38/128 (29.69%)  38
Pain  1  21/37 (56.76%)  21 97/128 (75.78%)  97
Swelling  1  7/37 (18.92%)  7 30/128 (23.44%)  30
Musculoskeletal and connective tissue disorders     
Myalgia  1  2/37 (5.41%)  2 1/128 (0.78%)  1
Nervous system disorders     
Headache  1  11/37 (29.73%)  15 46/128 (35.94%)  56
Reproductive system and breast disorders     
Dysmenorrhoea  1  2/37 (5.41%)  2 2/128 (1.56%)  2
Skin and subcutaneous tissue disorders     
Erythema  1  15/37 (40.54%)  15 47/128 (36.72%)  47
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by 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 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.
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: NCT01738477    
Other Study ID Numbers: 116570
First Submitted: November 21, 2012
First Posted: November 30, 2012
Results First Submitted: November 30, 2017
Results First Posted: December 27, 2017
Last Update Posted: June 6, 2018