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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058

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ClinicalTrials.gov Identifier: NCT00548171
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : January 15, 2019
Last Update Posted : January 15, 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
Conditions Acellular Pertussis
Tetanus
Diphtheria
Intervention Biological: Boostrix™
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 164 39
Completed 164 39
Not Completed 0 0
Arm/Group Title Boostrix I Group Boostrix II Group Total
Hide Arm/Group Description Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 164 39 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 39 participants 203 participants
50.1  (9.98) 51.0  (8.70) 50.27  (9.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 39 participants 203 participants
Female
107
  65.2%
33
  84.6%
140
  69.0%
Male
57
  34.8%
6
  15.4%
63
  31.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL)
Hide Description

Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).

The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.

Time Frame One month after the booster vaccination [PI(M1)]
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 153 35
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-DT ≥ 0.1 PI(M1) Number Analyzed 152 participants 35 participants
151
  99.3%
35
 100.0%
Anti-TT ≥ 0.1 PI(M1) Number Analyzed 153 participants 35 participants
153
 100.0%
35
 100.0%
2.Secondary Outcome
Title Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
Hide Description Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.
Time Frame Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 153 35
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-DT ≥ 0.1 IU/mL, PRE Number Analyzed 151 participants 34 participants
95
  62.9%
20
  58.8%
Anti-DT ≥ 0.1 IU/mL, PI(M1) Number Analyzed 152 participants 35 participants
151
  99.3%
35
 100.0%
Anti-DT ≥ 1 IU/mL, PRE Number Analyzed 151 participants 34 participants
24
  15.9%
7
  20.6%
Anti-DT ≥ 1 IU/mL, PI(M1) Number Analyzed 152 participants 35 participants
106
  69.7%
23
  65.7%
Anti-TT ≥ 0.1 IU/mL, PRE Number Analyzed 153 participants 35 participants
145
  94.8%
30
  85.7%
Anti-TT ≥ 0.1 IU/mL, PI(M1) Number Analyzed 153 participants 35 participants
153
 100.0%
35
 100.0%
Anti-TT ≥ 1 IU/mL, PRE Number Analyzed 153 participants 35 participants
90
  58.8%
23
  65.7%
Anti-TT ≥ 1 IU/mL, PI(M1) Number Analyzed 153 participants 35 participants
153
 100.0%
35
 100.0%
3.Secondary Outcome
Title Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Hide Description Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 153 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-DT, PRE Number Analyzed 151 participants 34 participants
0.200
(0.161 to 0.249)
0.233
(0.138 to 0.392)
Anti-DT, PI(M1) Number Analyzed 152 participants 35 participants
1.889
(1.547 to 2.306)
1.605
(1.111 to 2.319)
Anti-TT, PRE Number Analyzed 153 participants 35 participants
1.026
(0.859 to 1.224)
0.845
(0.538 to 1.327)
Anti-TT, PI(M1) Number Analyzed 153 participants 35 participants
6.927
(6.204 to 7.735)
5.933
(4.768 to 7.384)
4.Secondary Outcome
Title Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values
Hide Description

Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL.

This endpoint presents results for subjects included in the ATP cohort for antibody persistence.

Time Frame Prior (PRE) to booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 160 37
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-DT ≥ 0.1 IU/mL, PRE Number Analyzed 158 participants 36 participants
102
  64.6%
22
  61.1%
Anti-DT ≥ 1 IU/mL, PRE Number Analyzed 158 participants 36 participants
25
  15.8%
7
  19.4%
Anti-TT ≥ 0.1 IU/mL, PRE Number Analyzed 160 participants 37 participants
152
  95.0%
32
  86.5%
Anti-TT ≥ 1 IU/mL, PRE Number Analyzed 160 participants 37 participants
95
  59.4%
25
  67.6%
5.Secondary Outcome
Title Anti-DT and Anti-TT Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame Prior to the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 160 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-DT, PRE Number Analyzed 158 participants 36 participants
0.208
(0.168 to 0.257)
0.235
(0.144 to 0.384)
Anti-TT, PRE Number Analyzed 160 participants 37 participants
1.031
(0.868 to 1.225)
0.898
(0.581 to 1.386)
6.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Hide Description Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame Prior the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 158 36
Measure Type: Count of Participants
Unit of Measure: Participants
56
  35.4%
14
  38.9%
7.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Hide Description Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Time Frame Prior the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on those participants from the According to Protocol (ATP) cohort for antibody persistence who were found to be seronegative for anti-diphtheria antibodies as tested by ELISA.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 56 14
Measure Type: Count of Participants
Unit of Measure: Participants
16
  28.6%
4
  28.6%
8.Secondary Outcome
Title Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Hide Description Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
Time Frame Prior the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 160 37
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 160 participants 35 participants
137
  85.6%
23
  65.7%
Anti-FHA Number Analyzed 160 participants 37 participants
159
  99.4%
37
 100.0%
Anti-PRN Number Analyzed 159 participants 37 participants
151
  95.0%
33
  89.2%
9.Secondary Outcome
Title Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)
Time Frame Prior the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 160 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Number Analyzed 160 participants 35 participants
13.9
(11.9 to 16.2)
8.3
(5.9 to 11.7)
Anti-FHA Number Analyzed 160 participants 37 participants
137.2
(116.7 to 161.3)
115.6
(80.2 to 166.5)
Anti-PRN Number Analyzed 159 participants 37 participants
56.6
(44.2 to 72.4)
50.2
(27.9 to 90.4)
10.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.
Hide Description Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame Prior to the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 151 34
Measure Type: Count of Participants
Unit of Measure: Participants
56
  37.1%
14
  41.2%
11.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.
Hide Description Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Time Frame Prior to the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 56 14
Measure Type: Count of Participants
Unit of Measure: Participants
16
  28.6%
4
  28.6%
12.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Hide Description Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame One month after the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 152 35
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
0
   0.0%
13.Secondary Outcome
Title Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Hide Description Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Time Frame One month after the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
14.Secondary Outcome
Title Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Hide Description Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
Time Frame Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 153 35
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT, PRE Number Analyzed 153 participants 33 participants
131
  85.6%
22
  66.7%
Anti-PT, PI(M1) Number Analyzed 152 participants 35 participants
152
 100.0%
35
 100.0%
Anti-FHA, PRE Number Analyzed 153 participants 35 participants
152
  99.3%
35
 100.0%
Anti-FHA, PI(M1) Number Analyzed 152 participants 35 participants
152
 100.0%
35
 100.0%
Anti-PRN, PRE Number Analyzed 152 participants 35 participants
144
  94.7%
31
  88.6%
Anti-PRN, PI(M1) Number Analyzed 153 participants 34 participants
153
 100.0%
34
 100.0%
15.Secondary Outcome
Title Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Time Frame Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 153 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT, PRE Number Analyzed 153 participants 33 participants
13.9
(11.9 to 16.2)
8.4
(5.9 to 11.8)
Anti-PT, PI(M1) Number Analyzed 152 participants 35 participants
126.5
(109.9 to 145.6)
120.8
(88.9 to 164.2)
Anti-FHA, PRE Number Analyzed 153 participants 35 participants
140.2
(118.9 to 165.4)
119.3
(81.3 to 175.1)
Anti-FHA, PI(M1) Number Analyzed 152 participants 35 participants
615.3
(543.8 to 696.2)
677.4
(513.7 to 893.2)
Anti-PRN, PRE Number Analyzed 152 participants 35 participants
56.2
(43.6 to 72.5)
45.7
(24.9 to 83.7)
Anti-PRN, PI(M1) Number Analyzed 153 participants 34 participants
303.6
(259.6 to 355.0)
370.7
(280.5 to 489.9)
16.Secondary Outcome
Title Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Hide Description Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL).
Time Frame One month after the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 152 35
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 152 participants 33 participants
148
  97.4%
33
 100.0%
Anti-FHA Number Analyzed 152 participants 35 participants
119
  78.3%
31
  88.6%
Anti-PRN Number Analyzed 152 participants 34 participants
106
  69.7%
26
  76.5%
17.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Time Frame During the 4-day (Day 0–3) follow-up period after booster vaccination
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Hide Analysis Population Description
The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
142
  70.0%
Grade 3 Pain
2
   1.0%
Any Redness
72
  35.5%
Grade 3 Redness
14
   6.9%
Any Swelling
66
  32.5%
Grade 3 Swelling
20
   9.9%
18.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Time Frame During the 4-day (Day 0–3) follow-up period after booster vaccination
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Hide Analysis Population Description
The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
47
  23.2%
Grade 3 Fatigue
0
   0.0%
Related Fatigue
25
  12.3%
Any Fever
6
   3.0%
Grade 3 Fever
0
   0.0%
Related Fever
5
   2.5%
Any Gastrointestinal symptom
15
   7.4%
Grade 3 Gastrointestinal symptom
1
   0.5%
Related Gastrointestinal symptom
7
   3.4%
Any Headache
39
  19.2%
Grade 3 Headache
2
   1.0%
Related Headache
18
   8.9%
19.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
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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.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Time Frame During the 31-day (Day 0–30) follow-up period after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
35
  17.2%
20.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.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Time Frame Following the booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination).
Adverse Event Reporting Description For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
 
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
Boostrix Pooled Group
Affected / at Risk (%)
Total   0/203 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Boostrix Pooled Group
Affected / at Risk (%) # Events
Total   0/203 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Boostrix Pooled Group
Affected / at Risk (%) # Events
Total   163/203 (80.30%)    
Gastrointestinal disorders   
Gastrointestinal disorder  1  15/203 (7.39%)  15
General disorders   
Fatigue  1  47/203 (23.15%)  47
Pain  1  142/203 (69.95%)  142
Swelling  1  66/203 (32.51%)  66
Injection site pruritus  1  9/203 (4.43%)  9
Pyrexia  1  6/203 (2.96%)  6
Nervous system disorders   
Headache  1  40/203 (19.70%)  40
Skin and subcutaneous tissue disorders   
Erythema  1  72/203 (35.47%)  72
1
Term from vocabulary, MedDRA 9.0
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
Publications:
Booy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00548171     History of Changes
Other Study ID Numbers: 110804
First Submitted: October 22, 2007
First Posted: October 23, 2007
Results First Submitted: May 22, 2017
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019