Trial Outcomes & Findings for Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine. (NCT NCT00835237)
NCT ID: NCT00835237
Last Updated: 2020-01-03
Results Overview
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
COMPLETED
PHASE3
1332 participants
One month after vaccination.
2020-01-03
Participant Flow
Participant milestones
| Measure |
Boostrix Group
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Overall Study
STARTED
|
887
|
445
|
|
Overall Study
COMPLETED
|
881
|
445
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Boostrix Group
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
Baseline characteristics by cohort
| Measure |
Boostrix Group
n=887 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
Total
n=1332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 5.35 • n=93 Participants
|
71.9 years
STANDARD_DEVIATION 5.62 • n=4 Participants
|
71.7 years
STANDARD_DEVIATION 5.44 • n=27 Participants
|
|
Sex: Female, Male
Female
|
478 Participants
n=93 Participants
|
237 Participants
n=4 Participants
|
715 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
409 Participants
n=93 Participants
|
208 Participants
n=4 Participants
|
617 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination.Population: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
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
Outcome measures
| Measure |
Boostrix Group
n=864 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Anti-D (≥ 0.1 IU/mL) (N= 859;432)
|
729 subjects
|
374 subjects
|
|
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Anti-T (≥ 0.1 IU/mL) (N= 864;439)
|
836 subjects
|
428 subjects
|
|
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Anti-T (≥ 1.0 IU/mL) (N= 864;439)
|
767 subjects
|
395 subjects
|
PRIMARY outcome
Timeframe: Before (PRE) and one month after vaccination (POST)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
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)
Outcome measures
| Measure |
Boostrix Group
n=865 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-PT (PRE) (N=859;433)
|
6.6 EL.U/mL
Interval 6.1 to 7.1
|
6.5 EL.U/mL
Interval 5.8 to 7.2
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-PT (POST) (N=852;431)
|
49.1 EL.U/mL
Interval 44.9 to 53.7
|
6.4 EL.U/mL
Interval 5.8 to 7.1
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-FHA (PRE) (N=848;430)
|
50.2 EL.U/mL
Interval 46.2 to 54.5
|
44.3 EL.U/mL
Interval 39.5 to 49.5
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-FHA (POST) (N=835;428)
|
689.0 EL.U/mL
Interval 638.8 to 743.1
|
44.4 EL.U/mL
Interval 39.7 to 49.7
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-PRN (PRE) (N=864;439)
|
8.1 EL.U/mL
Interval 7.4 to 8.8
|
7.8 EL.U/mL
Interval 6.9 to 8.8
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Anti-PRN (POST) (N=865;439)
|
104.2 EL.U/mL
Interval 91.3 to 118.9
|
7.7 EL.U/mL
Interval 6.8 to 8.7
|
SECONDARY outcome
Timeframe: Before (PRE) and one month after vaccination (POST)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=864 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Anti-T and Anti-D Antibody Concentrations
Anti-D (PRE) (N=844;430)
|
0.2 IU/mL
Interval 0.2 to 0.2
|
0.2 IU/mL
Interval 0.1 to 0.2
|
|
Anti-T and Anti-D Antibody Concentrations
Anti-D (POST) (N=859;432)
|
0.9 IU/mL
Interval 0.8 to 1.0
|
0.8 IU/mL
Interval 0.7 to 1.0
|
|
Anti-T and Anti-D Antibody Concentrations
Anti-T (PRE) (N=864;439)
|
0.6 IU/mL
Interval 0.6 to 0.7
|
0.6 IU/mL
Interval 0.5 to 0.7
|
|
Anti-T and Anti-D Antibody Concentrations
Anti-T (POST) (N=864;439)
|
4.0 IU/mL
Interval 3.6 to 4.3
|
7.1 IU/mL
Interval 6.1 to 8.1
|
SECONDARY outcome
Timeframe: One month after vaccinationPopulation: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
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.
Outcome measures
| Measure |
Boostrix Group
n=863 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Anti-T (N=863;439)
|
438 subjects
|
306 subjects
|
|
Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Anti-D (N=842;428)
|
383 subjects
|
189 subjects
|
SECONDARY outcome
Timeframe: One month after vaccinationPopulation: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
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.
Outcome measures
| Measure |
Boostrix Group
n=864 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Anti-PT (N=846;430)
|
585 subjects
|
430 subjects
|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Anti-PRN (N=864;439)
|
638 subjects
|
9 subjects
|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Anti-FHA (N=821;422)
|
762 subjects
|
7 subjects
|
SECONDARY outcome
Timeframe: One month after vaccinationPopulation: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
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.
Outcome measures
| Measure |
Boostrix Group
n=864 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=439 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Anti-PT (N=846;430)
|
699 subjects
|
9 subjects
|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Anti-FHA (N=821;422)
|
765 subjects
|
8 subjects
|
|
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Anti-PRN (N=864;439)
|
714 subjects
|
11 subjects
|
SECONDARY outcome
Timeframe: Within the 4-day (Day 0-3) post-vaccination periodPopulation: Analysis was performed on the Total Vaccinated cohort on subjects with available results
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Boostrix Group
n=882 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
190 subjects
|
123 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
95 subjects
|
56 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
66 subjects
|
52 subjects
|
SECONDARY outcome
Timeframe: Within the 4-day (Day 0-3) post-vaccination periodPopulation: Analysis was performed on the Total Vaccinated cohort on subjects with available results
Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Outcome measures
| Measure |
Boostrix Group
n=882 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
101 subjects
|
52 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever
|
18 subjects
|
11 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
110 subjects
|
66 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal symptoms
|
67 subjects
|
41 subjects
|
SECONDARY outcome
Timeframe: Within the 31-day (Day 0-30) post-vaccination periodAn 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.
Outcome measures
| Measure |
Boostrix Group
n=887 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
152 subjects
|
64 subjects
|
SECONDARY outcome
Timeframe: From the vaccination up to Day 182An 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.
Outcome measures
| Measure |
Boostrix Group
n=887 Participants
Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 Participants
Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
37 subjects
|
10 subjects
|
Adverse Events
Boostrix Group
Decavac Group
Serious adverse events
| Measure |
Boostrix Group
n=887 participants at risk
Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 participants at risk
Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.34%
3/887
|
0.00%
0/445
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
2/887
|
0.22%
1/445
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
2/887
|
0.00%
0/445
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
2/887
|
0.00%
0/445
|
|
Infections and infestations
Pneumonia
|
0.23%
2/887
|
0.00%
0/445
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
2/887
|
0.00%
0/445
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/887
|
0.00%
0/445
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/887
|
0.00%
0/445
|
|
Vascular disorders
Aortic stenosis
|
0.11%
1/887
|
0.00%
0/445
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/887
|
0.22%
1/445
|
|
General disorders
Asthenia
|
0.11%
1/887
|
0.00%
0/445
|
|
Cardiac disorders
Atrial tachycardia
|
0.11%
1/887
|
0.00%
0/445
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/887
|
0.22%
1/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
1/887
|
0.00%
0/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.11%
1/887
|
0.00%
0/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/887
|
0.22%
1/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.11%
1/887
|
0.00%
0/445
|
|
Nervous system disorders
Carotid artery occlusion
|
0.11%
1/887
|
0.00%
0/445
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.11%
1/887
|
0.00%
0/445
|
|
Nervous system disorders
Cervical myelopathy
|
0.11%
1/887
|
0.00%
0/445
|
|
General disorders
Chest pain
|
0.11%
1/887
|
0.00%
0/445
|
|
Nervous system disorders
Complicated migraine
|
0.11%
1/887
|
0.00%
0/445
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
1/887
|
0.00%
0/445
|
|
Nervous system disorders
Dementia
|
0.00%
0/887
|
0.22%
1/445
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/887
|
0.00%
0/445
|
|
Infections and infestations
Enterococcal sepsis
|
0.11%
1/887
|
0.00%
0/445
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/887
|
0.22%
1/445
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/887
|
0.22%
1/445
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
1/887
|
0.00%
0/445
|
|
General disorders
Hernia obstructive
|
0.11%
1/887
|
0.00%
0/445
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/887
|
0.22%
1/445
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.11%
1/887
|
0.00%
0/445
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.11%
1/887
|
0.00%
0/445
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/887
|
0.22%
1/445
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.11%
1/887
|
0.00%
0/445
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/887
|
0.22%
1/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.11%
1/887
|
0.00%
0/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/887
|
0.22%
1/445
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.11%
1/887
|
0.00%
0/445
|
|
Infections and infestations
Osteomyelitis
|
0.11%
1/887
|
0.00%
0/445
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.11%
1/887
|
0.00%
0/445
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
1/887
|
0.00%
0/445
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/887
|
0.00%
0/445
|
|
Cardiac disorders
Sick sinus syndrome
|
0.11%
1/887
|
0.00%
0/445
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.11%
1/887
|
0.00%
0/445
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.11%
1/887
|
0.00%
0/445
|
Other adverse events
| Measure |
Boostrix Group
n=887 participants at risk
Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
|
Decavac Group
n=445 participants at risk
Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
|
|---|---|---|
|
General disorders
Pain
|
21.4%
190/887
|
27.6%
123/445
|
|
General disorders
Redness
|
10.7%
95/887
|
12.6%
56/445
|
|
General disorders
Swelling
|
7.4%
66/887
|
11.7%
52/445
|
|
General disorders
Fatigue
|
12.4%
110/887
|
14.8%
66/445
|
|
General disorders
Gastrointestinal symptoms
|
7.6%
67/887
|
9.2%
41/445
|
|
General disorders
Headache
|
11.4%
101/887
|
11.7%
52/445
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER