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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

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ClinicalTrials.gov Identifier: NCT00610168
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : March 30, 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 Acellular Pertussis
Tetanus
Diphtheria
Intervention Biological: Boostrix TM
Enrollment 82
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 I Group Boostrix II Group
Hide Arm/Group Description Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 75 7
Completed 73 7
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Boostrix I Group Boostrix II Group Total
Hide Arm/Group Description Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 75 7 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 7 participants 82 participants
21.1  (0.31) 21.1  (0.38) 21.1  (0.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 7 participants 82 participants
Female
66
  88.0%
6
  85.7%
72
  87.8%
Male
9
  12.0%
1
  14.3%
10
  12.2%
1.Primary Outcome
Title Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
Hide Description The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 7
Measure Type: Number
Unit of Measure: Subjects
Anti-diphtheria ≥ 0.1 IU/mL 61 5
Anti-diphtheria ≥ 1 IU/mL 17 0
Anti-tetanus ≥ 0.1 IU/mL 72 7
Anti-tetanus ≥ 1 IU/mL 44 4
2.Primary Outcome
Title Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
Hide Description The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 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 analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 73 7
Measure Type: Number
Unit of Measure: Subjects
Anti-diphtheria ≥ 0.1 IU/mL 73 7
Anti-diphtheria ≥ 1 IU/mL 68 7
Anti-tetanus ≥ 0.1 IU/mL 73 7
Anti-tetanus ≥ 1 IU/mL 71 7
3.Secondary Outcome
Title Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Hide Description Concentrations are presented as international units per millilitre (IU/mL).
Time Frame At Month 0 (PRE) and Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-diphtheria Pre [N=74;7]
0.318
(0.24 to 0.421)
0.196
(0.068 to 0.568)
Anti-diphtheria Post [N=73;7]
5.994
(4.679 to 7.68)
3.226
(1.741 to 5.975)
Anti-tetanus Pre [N=74;7]
1.246
(0.956 to 1.623)
0.989
(0.498 to 1.961)
Anti-tetanus Post [N=73;7]
9.596
(7.986 to 11.531)
8.975
(5.277 to 15.264)
4.Secondary Outcome
Title Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Hide Description A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)
Time Frame At Month 0 (PRE) and Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 7
Measure Type: Number
Unit of Measure: Subjects
Anti-PT Pre [N=75;7] 46 7
Anti-PT Post [N=73;7] 73 7
Anti-FHA Pre [N=75;7] 75 7
Anti-FHA Post [N=73;7] 73 7
Anti-PRN Pre [N=75;7] 72 7
Anti-PRN Post [N=73;7] 73 7
5.Secondary Outcome
Title Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (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 At Month 0 (PRE) and Month 1 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Pre [N=75;7]
9.1
(6.9 to 11.9)
12.5
(8.8 to 17.9)
Anti-PT Post [N=73;7]
90.3
(73.9 to 110.5)
116.5
(56.5 to 240.5)
Anti-FHA Pre [N=75;7]
63.8
(53.1 to 76.8)
118.8
(80.6 to 175.1)
Anti-FHA Post [N=73;7]
793.4
(670.3 to 939.2)
584.3
(248.3 to 1374.9)
Anti-PRN Pre [N=75;7]
36.9
(27.7 to 49.2)
41.8
(20.3 to 85.9)
Anti-PRN Post [N=73;7]
548.1
(456.9 to 657.5)
685.3
(243.5 to 1928.4)
6.Secondary Outcome
Title Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (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 prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 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 analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
Arm/Group Title Boostrix I Group Boostrix II Group
Hide Arm/Group Description:
Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 73 7
Measure Type: Number
Unit of Measure: Subjects
Anti-PT [N=73;7] 72 7
Anti-FHA [N=73;7] 71 6
Anti-PRN [N=73;7] 68 7
7.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.
Time Frame During the 4-day (Day 0–3) follow-up period after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Boostrix I and Boostrix II Groups pooled together.
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: Subjects
Any pain 76
Grade 3 pain 8
Any redness 48
Grade 3 redness 14
Any swelling 46
Grade 3 swelling 15
8.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. 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.
Time Frame During the 4-day (Day 0–3) follow-up period after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Boostrix I and Boostrix II Groups pooled together.
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue 44
Grade 3 Fatigue 2
Related Fatigue 36
Any Fever 7
Grade 3 Fever 0
Related Fever 7
Any Gastrointestinal symptoms 14
Grade 3 Gastrointestinal symptoms 1
Related Gastrointestinal symptoms 8
Any Headache 27
Grade 3 Headache 0
Related Headache 22
9.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.
Time Frame During the 31-day (Day 0–30) follow-up period after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Boostrix I and Boostrix II Groups pooled together.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: Subjects
26
10.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 For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description:
Boostrix I and Boostrix II Groups pooled together.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: Subjects
1
Time Frame Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boostrix Pooled Group
Hide Arm/Group Description Boostrix I and Boostrix II Groups pooled together.
All-Cause Mortality
Boostrix Pooled Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Boostrix Pooled Group
Affected / at Risk (%)
Total   1/82 (1.22%) 
Respiratory, thoracic and mediastinal disorders   
Hyperventilation  1  1/82 (1.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boostrix Pooled Group
Affected / at Risk (%)
Total   78/82 (95.12%) 
General disorders   
Pain  1  76/82 (92.68%) 
Redness  1  48/82 (58.54%) 
Swelling  1  46/82 (56.10%) 
Fatigue  1  44/82 (53.66%) 
Fever (Axillary)  1  7/82 (8.54%) 
Gastrointestinal symptoms  1  14/82 (17.07%) 
Headache  1  27/82 (32.93%) 
Infections and infestations   
Influenza  1  6/82 (7.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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:
He Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.
Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. 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-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00610168     History of Changes
Other Study ID Numbers: 110806
First Submitted: January 25, 2008
First Posted: February 7, 2008
Results First Submitted: February 9, 2017
Results First Posted: March 30, 2017
Last Update Posted: June 6, 2018