Trial Outcomes & Findings for A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older (NCT NCT00457249)
NCT ID: NCT00457249
Last Updated: 2012-10-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1564 participants
Primary outcome timeframe
Day 35 post-vaccination
Results posted on
2012-10-19
Participant Flow
Participants were enrolled from 28 March to 30 October 2007, at 19 clinic centers in United States.
A total of 1563 participants were enrolled; 1561 were vaccinated with data analyzed and presented in this report.
Participant milestones
| Measure |
ADACEL® Vaccine Group
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
Participants received a single dose of DECAVAC® vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
1170
|
391
|
|
Overall Study
COMPLETED
|
1158
|
389
|
|
Overall Study
NOT COMPLETED
|
12
|
2
|
Reasons for withdrawal
| Measure |
ADACEL® Vaccine Group
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
Participants received a single dose of DECAVAC® vaccine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Serious Adverse Events
|
2
|
0
|
Baseline Characteristics
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
Baseline characteristics by cohort
| Measure |
ADACEL® Vaccine Group
n=1170 Participants
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=391 Participants
Participants received a single dose of ADACEL® vaccine.
|
Total
n=1561 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1170 Participants
n=5 Participants
|
391 Participants
n=7 Participants
|
1561 Participants
n=5 Participants
|
|
Age Continuous
|
72.2 Years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
72.3 Years
STANDARD_DEVIATION 5.63 • n=7 Participants
|
72.2 Years
STANDARD_DEVIATION 5.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
579 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
777 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
591 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
784 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1170 participants
n=5 Participants
|
391 participants
n=7 Participants
|
1561 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 35 post-vaccinationPopulation: GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.
Outcome measures
| Measure |
ADACEL® Vaccine Group
n=1094 Participants
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=371 Participants
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Pertussis Toxoid (Post-vaccination: N = 1022; 341)
|
59.4 Titers
Interval 55.2 to 63.8
|
15 Titers
Interval 13.1 to 17.2
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Fimbriae Type 2 & 3 (Pre-Vaccination: N=1053; 370)
|
8.28 Titers
Interval 7.46 to 9.19
|
9.59 Titers
Interval 7.94 to 11.6
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Fimbriae Type 2 & 3 (Post-Vaccination: N=1060; 352
|
183 Titers
Interval 164.0 to 205.0
|
10.6 Titers
Interval 8.79 to 12.9
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Tetanus (Pre-vaccination: N = 1089; 368)
|
0.501 Titers
Interval 0.445 to 0.564
|
0.451 Titers
Interval 0.365 to 0.558
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Tetanus (Post-vaccination: N = 1075; 368)
|
8.43 Titers
Interval 7.78 to 9.14
|
7.23 Titers
Interval 6.23 to 8.38
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Diphtheria (Pre-vaccination: N = 1092; 370)
|
0.049 Titers
Interval 0.043 to 0.056
|
0.056 Titers
Interval 0.045 to 0.071
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Diphtheria (Post-vaccination: N = 1093; 371)
|
0.570 Titers
Interval 0.489 to 0.665
|
0.505 Titers
Interval 0.401 to 0.636
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Pertussis Toxoid (Pre-vaccination: N = 1013; 345)
|
10.6 Titers
Interval 9.81 to 11.5
|
12.7 Titers
Interval 11.1 to 14.5
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Filamentous Hemagglutinin (Pre-vacc: N=1091; 370)
|
25.5 Titers
Interval 23.9 to 27.1
|
25.6 Titers
Interval 22.8 to 28.8
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Filamentous Hemagglutinin (Post-Vacc: N=1094; 371)
|
197 Titers
Interval 186.0 to 209.0
|
26.6 Titers
Interval 23.7 to 30.0
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Pertactin (Pre-Vaccination: N = 1090; 370)
|
4.56 Titers
Interval 4.26 to 4.88
|
4.71 Titers
Interval 4.18 to 5.31
|
|
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Pertactin (Post-Vaccination: N = 1094; 370)
|
69.2 Titers
Interval 61.6 to 77.9
|
5.34 Titers
Interval 4.72 to 6.04
|
PRIMARY outcome
Timeframe: Day 35 post-vaccinationPopulation: Seroprotection was assessed in the per-protocol population
Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.
Outcome measures
| Measure |
ADACEL® Vaccine Group
n=1093 Participants
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=371 Participants
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
Tetanus (N = 1075; 368)
|
98 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
Diphtheria (N = 1093; 371)
|
77 Percentage of Participants
|
79 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 35 post-vaccinationPopulation: Booster response was assessed in the per-protocol population.
Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.
Outcome measures
| Measure |
ADACEL® Vaccine Group
n=1091 Participants
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=370 Participants
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
Tetanus (N = 1071; 365)
|
77 Percentage of Participants
|
77 Percentage of Participants
|
|
Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
Diphtheria (N = 1091; 370)
|
71 Percentage of Participants
|
66 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to 14 days post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.
Outcome measures
| Measure |
ADACEL® Vaccine Group
n=1170 Participants
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=391 Participants
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 Malaise (Incapacitating)
|
13 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Solicited Injection Site Reaction
|
615 Participants
|
200 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any injection site Pain
|
496 Participants
|
163 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 injection site Pain (Incapacitating)
|
6 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any injection site Erythema
|
280 Participants
|
86 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 injection site Erythema (≥ 3.5 cm)
|
52 Participants
|
19 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any injection site Swelling
|
209 Participants
|
59 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 injection site Swelling (≥ 3.5 cm)
|
40 Participants
|
17 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Solicited Systemic Reaction
|
420 Participants
|
155 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Fever
|
6 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 Fever (≥ 39.5ºC or ≥ 103.1ºF)
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Headache
|
209 Participants
|
76 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 Headache (Incapacitating)
|
7 Participants
|
4 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Myalgia
|
327 Participants
|
108 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Grade 3 Myalgia (Incapacitating)
|
17 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Any Malaise
|
198 Participants
|
63 Participants
|
Adverse Events
ADACEL® Vaccine Group
Serious events: 49 serious events
Other events: 615 other events
Deaths: 0 deaths
DECAVAC® Vaccine Group
Serious events: 20 serious events
Other events: 200 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADACEL® Vaccine Group
n=1170 participants at risk
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=391 participants at risk
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
4/1170 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
4/1170 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.26%
3/1170 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
2/1170 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Endocrine disorders
Adrenocortical insufficiency chronic
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Melaena
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Volvulus
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Hernia obstructive
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Multi-organ failure
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
2/1170 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.51%
2/391 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.51%
2/391 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Bursitis infective
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Escherichia infection
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.26%
3/1170 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Sepsis
|
0.17%
2/1170 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Viral infection
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
4/1170 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Syncope
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.17%
2/1170 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.26%
1/391 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Vascular disorders
Hypertensive crisis
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Vascular disorders
Peripheral embolism
|
0.09%
1/1170 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
Other adverse events
| Measure |
ADACEL® Vaccine Group
n=1170 participants at risk
Participants received a single dose of ADACEL® vaccine.
|
DECAVAC® Vaccine Group
n=391 participants at risk
Participants received a single dose of ADACEL® vaccine.
|
|---|---|---|
|
General disorders
Injection site pain
|
42.4%
496/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
41.7%
163/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Injection site erythema
|
23.9%
280/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
22.0%
86/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Injection site swelling
|
17.9%
209/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
15.1%
59/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache
|
17.9%
209/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
19.4%
76/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.9%
327/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
27.6%
108/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Malaise
|
16.9%
198/1170 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
16.1%
63/391 • Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER