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Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

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ClinicalTrials.gov Identifier: NCT00835237
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 5, 2010
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Tetanus
Acellular Pertussis
Diphtheria
Diphtheria-Tetanus-acellular Pertussis Vaccines
Interventions Biological: Boostrix®
Biological: Decavac™
Enrollment 1332
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Period Title: Overall Study
Started 887 445
Completed 881 445
Not Completed 6 0
Reason Not Completed
Lost to Follow-up             4             0
Withdrawal by Subject             2             0
Arm/Group Title Boostrix Group Decavac Group Total
Hide Arm/Group Description Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine) Total of all reporting groups
Overall Number of Baseline Participants 887 445 1332
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 887 participants 445 participants 1332 participants
71.6  (5.35) 71.9  (5.62) 71.7  (5.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 887 participants 445 participants 1332 participants
Female
478
  53.9%
237
  53.3%
715
  53.7%
Male
409
  46.1%
208
  46.7%
617
  46.3%
1.Primary Outcome
Title Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Hide Description

Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).

Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)

Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Time Frame One month after vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 864 439
Measure Type: Number
Unit of Measure: subjects
Anti-D (≥ 0.1 IU/mL) (N= 859;432) 729 374
Anti-T (≥ 0.1 IU/mL) (N= 864;439) 836 428
Anti-T (≥ 1.0 IU/mL) (N= 864;439) 767 395
2.Primary Outcome
Title Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Hide Description Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
Time Frame Before (PRE) and one month after vaccination (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 865 439
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT (PRE) (N=859;433)
6.6
(6.1 to 7.1)
6.5
(5.8 to 7.2)
Anti-PT (POST) (N=852;431)
49.1
(44.9 to 53.7)
6.4
(5.8 to 7.1)
Anti-FHA (PRE) (N=848;430)
50.2
(46.2 to 54.5)
44.3
(39.5 to 49.5)
Anti-FHA (POST) (N=835;428)
689.0
(638.8 to 743.1)
44.4
(39.7 to 49.7)
Anti-PRN (PRE) (N=864;439)
8.1
(7.4 to 8.8)
7.8
(6.9 to 8.8)
Anti-PRN (POST) (N=865;439)
104.2
(91.3 to 118.9)
7.7
(6.8 to 8.7)
3.Secondary Outcome
Title Anti-T and Anti-D Antibody Concentrations
Hide Description Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Time Frame Before (PRE) and one month after vaccination (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 864 439
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D (PRE) (N=844;430)
0.2
(0.2 to 0.2)
0.2
(0.1 to 0.2)
Anti-D (POST) (N=859;432)
0.9
(0.8 to 1.0)
0.8
(0.7 to 1.0)
Anti-T (PRE) (N=864;439)
0.6
(0.6 to 0.7)
0.6
(0.5 to 0.7)
Anti-T (POST) (N=864;439)
4.0
(3.6 to 4.3)
7.1
(6.1 to 8.1)
4.Secondary Outcome
Title Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Hide Description

Booster response defined as :

For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.

For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time Frame One month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 863 439
Measure Type: Number
Unit of Measure: subjects
Anti-D (N=842;428) 383 189
Anti-T (N=863;439) 438 306
5.Secondary Outcome
Title Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Hide Description

Booster response defined as :

For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.

For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.

For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
Time Frame One month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 864 439
Measure Type: Number
Unit of Measure: subjects
Anti-PT (N=846;430) 585 430
Anti-FHA (N=821;422) 762 7
Anti-PRN (N=864;439) 638 9
6.Secondary Outcome
Title Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Hide Description

Vaccine response using alternative definitions defined as:

For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.

For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
Time Frame One month after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 864 439
Measure Type: Number
Unit of Measure: subjects
Anti-PT (N=846;430) 699 9
Anti-FHA (N=821;422) 765 8
Anti-PRN (N=864;439) 714 11
7.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame Within the 4-day (Day 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 882 445
Measure Type: Number
Unit of Measure: subjects
Pain 190 123
Redness 95 56
Swelling 66 52
8.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Time Frame Within the 4-day (Day 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort on subjects with available results
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 882 445
Measure Type: Number
Unit of Measure: subjects
Fatigue 110 66
Gastrointestinal symptoms 67 41
Headache 101 52
Fever 18 11
9.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Within the 31-day (Day 0-30) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 887 445
Measure Type: Number
Unit of Measure: subjects
152 64
10.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE)
Hide Description An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame From the vaccination up to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description:
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
Overall Number of Participants Analyzed 887 445
Measure Type: Number
Unit of Measure: subjects
37 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boostrix Group Decavac Group
Hide Arm/Group Description Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
All-Cause Mortality
Boostrix Group Decavac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Boostrix Group Decavac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   37/887 (4.17%)   10/445 (2.25%) 
Cardiac disorders     
Coronary artery disease *  3/887 (0.34%)  0/445 (0.00%) 
Myocardial infarction *  2/887 (0.23%)  1/445 (0.22%) 
Acute myocardial infarction *  1/887 (0.11%)  0/445 (0.00%) 
Angina pectoris *  1/887 (0.11%)  0/445 (0.00%) 
Atrial tachycardia *  1/887 (0.11%)  0/445 (0.00%) 
Atrioventricular block complete *  0/887 (0.00%)  1/445 (0.22%) 
Sick sinus syndrome *  1/887 (0.11%)  0/445 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage *  1/887 (0.11%)  0/445 (0.00%) 
Inguinal hernia, obstructive *  1/887 (0.11%)  0/445 (0.00%) 
General disorders     
Asthenia *  1/887 (0.11%)  0/445 (0.00%) 
Chest pain *  1/887 (0.11%)  0/445 (0.00%) 
Hernia obstructive *  1/887 (0.11%)  0/445 (0.00%) 
Infections and infestations     
Pneumonia *  2/887 (0.23%)  0/445 (0.00%) 
Enterococcal sepsis *  1/887 (0.11%)  0/445 (0.00%) 
Gastroenteritis *  0/887 (0.00%)  1/445 (0.22%) 
Klebsiella bacteraemia *  1/887 (0.11%)  0/445 (0.00%) 
Lobar pneumonia *  0/887 (0.00%)  1/445 (0.22%) 
Osteomyelitis *  1/887 (0.11%)  0/445 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture *  2/887 (0.23%)  0/445 (0.00%) 
Femur fracture *  0/887 (0.00%)  1/445 (0.22%) 
Meniscus lesion *  1/887 (0.11%)  0/445 (0.00%) 
Road traffic accident *  1/887 (0.11%)  0/445 (0.00%) 
Vascular graft occlusion *  1/887 (0.11%)  0/445 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia *  0/887 (0.00%)  1/445 (0.22%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  0/887 (0.00%)  1/445 (0.22%) 
Osteoarthritis *  1/887 (0.11%)  0/445 (0.00%) 
Spinal column stenosis *  1/887 (0.11%)  0/445 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma *  1/887 (0.11%)  0/445 (0.00%) 
Bone neoplasm malignant *  1/887 (0.11%)  0/445 (0.00%) 
Breast cancer in situ *  0/887 (0.00%)  1/445 (0.22%) 
Bronchial carcinoma *  1/887 (0.11%)  0/445 (0.00%) 
Non-Hodgkin's lymphoma *  1/887 (0.11%)  0/445 (0.00%) 
Non-small cell lung cancer metastatic *  0/887 (0.00%)  1/445 (0.22%) 
Prostate cancer *  1/887 (0.11%)  0/445 (0.00%) 
Nervous system disorders     
Cerebrovascular accident *  2/887 (0.23%)  0/445 (0.00%) 
Transient ischaemic attack *  2/887 (0.23%)  0/445 (0.00%) 
Carotid artery occlusion *  1/887 (0.11%)  0/445 (0.00%) 
Cerebral haemorrhage *  1/887 (0.11%)  0/445 (0.00%) 
Cervical myelopathy *  1/887 (0.11%)  0/445 (0.00%) 
Complicated migraine *  1/887 (0.11%)  0/445 (0.00%) 
Dementia *  0/887 (0.00%)  1/445 (0.22%) 
Renal and urinary disorders     
Nephrolithiasis *  0/887 (0.00%)  1/445 (0.22%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea *  1/887 (0.11%)  0/445 (0.00%) 
Pulmonary embolism *  1/887 (0.11%)  0/445 (0.00%) 
Vascular disorders     
Aortic stenosis *  1/887 (0.11%)  0/445 (0.00%) 
Deep vein thrombosis *  1/887 (0.11%)  0/445 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boostrix Group Decavac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   351/887 (39.57%)   202/445 (45.39%) 
General disorders     
Pain †  190/887 (21.42%)  123/445 (27.64%) 
Redness †  95/887 (10.71%)  56/445 (12.58%) 
Swelling †  66/887 (7.44%)  52/445 (11.69%) 
Fatigue †  110/887 (12.40%)  66/445 (14.83%) 
Gastrointestinal symptoms †  67/887 (7.55%)  41/445 (9.21%) 
Headache †  101/887 (11.39%)  52/445 (11.69%) 
†
Indicates events were collected by systematic assessment
[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:
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00835237    
Other Study ID Numbers: 111413
First Submitted: February 2, 2009
First Posted: February 3, 2009
Results First Submitted: July 8, 2010
Results First Posted: August 5, 2010
Last Update Posted: January 3, 2020