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Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

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: NCT01362322
Recruitment Status : Completed
First Posted : May 30, 2011
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Acellular Pertussis
Interventions Biological: Boostrix TM (new syringe presentation)
Biological: Boostrix TM (previous syringe presentation)
Enrollment 671
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Period Title: Overall Study
Started 335 336
Completed 330 329
Not Completed 5 7
Reason Not Completed
Withdrawal by Subject             3             1
Lost to Follow-up             2             6
Arm/Group Title Boostrix New Group Boostrix Prev Group Total
Hide Arm/Group Description Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 335 336 671
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants 336 participants 671 participants
11.9  (1.59) 11.9  (1.61) 11.9  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants 336 participants 671 participants
Female
179
  53.4%
178
  53.0%
357
  53.2%
Male
156
  46.6%
158
  47.0%
314
  46.8%
1.Primary Outcome
Title Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
6.784
(6.178 to 7.45)
6.493
(5.915 to 7.128)
Anti-T
18.937
(17.313 to 20.713)
18.515
(16.851 to 20.342)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Boostrix New Group, Boostrix Prev Group
Comments Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted radio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.85 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boostrix New Group, Boostrix Prev Group
Comments Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.86 to 1.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Number Analyzed 318 participants 318 participants
140.2
(126 to 156.1)
125.9
(112.7 to 140.7)
Anti-FHA Number Analyzed 319 participants 319 participants
1080.2
(995.2 to 1172.5)
1013.7
(940 to 1093.2)
Anti-PRN Number Analyzed 321 participants 318 participants
652.4
(572.1 to 743.9)
619.2
(546 to 702.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Boostrix New Group, Boostrix Prev Group
Comments Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.82 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boostrix New Group, Boostrix Prev Group
Comments Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Method of Estimation Estimation Parameter Adjusted Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.83 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Boostrix New Group, Boostrix Prev Group
Comments Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Method of Estimation Estimation Parameter Adjusted ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.85 to 1.13
Estimation Comments [Not Specified]
3.Primary Outcome
Title Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
0.472
(0.403 to 0.553)
0.456
(0.392 to 0.53)
Anti-T
0.956
(0.835 to 1.095)
0.899
(0.789 to 1.026)
4.Primary Outcome
Title Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT PRE Number Analyzed 320 participants 319 participants
7.5
(6.6 to 8.7)
7.2
(6.3 to 8.2)
Anti-FHA PRE Number Analyzed 316 participants 315 participants
48.9
(43.3 to 55.2)
49.4
(43.6 to 56)
Anti-PRN PRE Number Analyzed 321 participants 319 participants
14
(12.3 to 15.9)
13.4
(11.9 to 15)
5.Secondary Outcome
Title Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Hide Description A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).
Time Frame At Day 0 (PRE) and at Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D PRE
284
  88.5%
286
  89.7%
Anti-D POST
320
  99.7%
319
 100.0%
Anti-T PRE
311
  96.9%
314
  98.4%
Anti-T POST
321
 100.0%
319
 100.0%
6.Secondary Outcome
Title Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Hide Description A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).
Time Frame At Day 0 (PRE) vaccine and at Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D PRE
83
  25.9%
89
  27.9%
Anti-D POST
315
  98.1%
310
  97.2%
Anti-T PRE
151
  47.0%
143
  44.8%
Anti-T POST
321
 100.0%
319
 100.0%
7.Secondary Outcome
Title Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
Hide Description A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time Frame At Day 0 (PRE) vaccine and at Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT PRE Number Analyzed 320 participants 319 participants
175
  54.7%
175
  54.9%
Anti-PT POST Number Analyzed 318 participants 318 participants
316
  99.4%
315
  99.1%
Anti-FHA PRE Number Analyzed 316 participants 315 participants
310
  98.1%
310
  98.4%
Anti-FHA POST Number Analyzed 319 participants 319 participants
319
 100.0%
319
 100.0%
Anti-PRN PRE Number Analyzed 321 participants 319 participants
269
  83.8%
272
  85.3%
Anti-PRN POST Number Analyzed 321 participants 318 participants
321
 100.0%
318
 100.0%
8.Secondary Outcome
Title Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
Hide Description Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 319
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
257
  80.1%
252
  79.0%
Anti-T
266
  82.9%
270
  84.6%
9.Secondary Outcome
Title Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
Hide Description Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); for initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 321 318
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 317 participants 318 participants
298
  94.0%
295
  92.8%
Anti-FHA Number Analyzed 314 participants 315 participants
305
  97.1%
304
  96.5%
Anti-PRN Number Analyzed 321 participants 318 participants
315
  98.1%
317
  99.7%
10.Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame Within 4 days (Days 0-3) post vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 330 329
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
237
  71.8%
248
  75.4%
Any Redness
113
  34.2%
94
  28.6%
Any Swelling
98
  29.7%
90
  27.4%
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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame Within 31 days (Days 0-30) post
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 335 336
Measure Type: Count of Participants
Unit of Measure: Participants
44
  13.1%
45
  13.4%
12.Secondary Outcome
Title Number of Subjects With Any Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.
Time Frame Within 4 days (Days 0-3) post vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 330 329
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
83
  25.2%
86
  26.1%
Any Gastrointestinal symptoms
32
   9.7%
42
  12.8%
Any Headache
88
  26.7%
108
  32.8%
Any Temperature
9
   2.7%
6
   1.8%
13.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (Day 0 - Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description:
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Number of Participants Analyzed 335 336
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
0
   0.0%
Time Frame Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boostrix New Group Boostrix Prev Group
Hide Arm/Group Description Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
All-Cause Mortality
Boostrix New Group Boostrix Prev Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Boostrix New Group Boostrix Prev Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/335 (0.30%)      0/336 (0.00%)    
Injury, poisoning and procedural complications     
Injury * 1  1/335 (0.30%)  1 0/336 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boostrix New Group Boostrix Prev Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   263/335 (78.51%)      279/336 (83.04%)    
Gastrointestinal disorders     
Gastrointestinal disorder † 1  32/335 (9.55%)  32 42/336 (12.50%)  42
General disorders     
Fatigue † 1  83/335 (24.78%)  83 86/336 (25.60%)  86
Pain † 1  237/335 (70.75%)  237 248/336 (73.81%)  248
Swelling † 1  98/335 (29.25%)  98 90/336 (26.79%)  90
Nervous system disorders     
Headache † 1  89/335 (26.57%)  90 109/336 (32.44%)  110
Skin and subcutaneous tissue disorders     
Erythema † 1  113/335 (33.73%)  113 94/336 (27.98%)  94
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01362322    
Other Study ID Numbers: 114778
First Submitted: May 19, 2011
First Posted: May 30, 2011
Results First Submitted: March 23, 2017
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018