Trial Outcomes & Findings for Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose (NCT NCT00712959)
NCT ID: NCT00712959
Last Updated: 2014-04-30
Results Overview
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
769 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and 30 post-vaccination
Results posted on
2014-04-30
Participant Flow
Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.
A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.
Participant milestones
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Overall Study
STARTED
|
361
|
407
|
|
Overall Study
COMPLETED
|
342
|
404
|
|
Overall Study
NOT COMPLETED
|
19
|
3
|
Reasons for withdrawal
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
Baseline characteristics by cohort
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=361 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=407 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
Total
n=768 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
|
356 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
758 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
31.2 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
33.0 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
361 participants
n=5 Participants
|
407 participants
n=7 Participants
|
768 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and 30 post-vaccinationPopulation: Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-tetanus Pre-vaccination
|
45 Percentage of Participants
|
49 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-tetanus Post-vaccination
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-Diphtheria Pre-vaccination
|
74 Percentage of Participants
|
66 Percentage of Participants
|
|
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-Diphtheria Post-vaccination
|
99 Percentage of Participants
|
96 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Geometric mean concentrations were assessed in the per-protocol population.
Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Filamentous Haemagglutinin [n=324, 380]
|
214 EU/mL
Interval 199.0 to 231.0
|
249 EU/mL
Interval 229.0 to 272.0
|
|
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertactin [n=324, 381]
|
266 EU/mL
Interval 243.0 to 292.0
|
216 EU/mL
Interval 188.0 to 247.0
|
|
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Fimbriae Types 2 and 3 [n=324, 378]
|
779 EU/mL
Interval 720.0 to 843.0
|
1015 EU/mL
Interval 894.0 to 1154.0
|
|
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertussis Toxoid [n=318, 357]
|
116 EU/mL
Interval 105.0 to 129.0
|
89.2 EU/mL
Interval 80.2 to 99.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30 post-vaccinationPopulation: Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.
Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of \< 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to \< 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-Tetanus [N = 324, 379]
|
83 Percentage of Participants
|
82 Percentage of Participants
|
|
Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-Diphtheria [N = 324, 381]
|
86 Percentage of Participants
|
81 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30 post-vaccinationPopulation: Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.
Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration: * ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was \< LLOQ; or * ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but \< 4 x LLOQ; or * ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-Pertussis Toxoid [N = 285, 330]
|
88 Percentage of Particpants
|
84 Percentage of Particpants
|
|
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Filamentous Haemagglutinin [N = 324, 379]
|
88 Percentage of Particpants
|
94 Percentage of Particpants
|
|
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Pertactin [N = 324, 381]
|
90 Percentage of Particpants
|
93 Percentage of Particpants
|
|
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Fimbriae Types 2 and 3 [N = 324, 371]
|
84 Percentage of Particpants
|
93 Percentage of Particpants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean concentrations were assessed in the per-protocol population.
Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertussis Toxoid [Pre, N = 291, 353]
|
15.1 EU/mL
Interval 12.9 to 17.6
|
9.42 EU/mL
Interval 8.2 to 10.8
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertussis Toxoid [Post, N = 318, 357]
|
116 EU/mL
Interval 105.0 to 129.0
|
89.2 EU/mL
Interval 80.2 to 99.3
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Filamentous Haemagglutinin [Pre, N = 324, 380]
|
34.8 EU/mL
Interval 31.2 to 38.7
|
20.0 EU/mL
Interval 17.7 to 22.5
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Filamentous Haemagglutinin [Post, N = 324, 380]
|
214 EU/mL
Interval 199.0 to 231.0
|
249 EU/mL
Interval 229.0 to 272.0
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertactin [Pre, N = 324, 381]
|
28.2 EU/mL
Interval 24.4 to 32.7
|
8.54 EU/mL
Interval 7.41 to 9.85
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Pertactin [Post, N = 324, 381]
|
266 EU/mL
Interval 243.0 to 292.0
|
216 EU/mL
Interval 188.0 to 247.0
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Fimbriae Types 2 and 3 [Pre, N = 324, 374]
|
124 EU/mL
Interval 111.0 to 139.0
|
37.8 EU/mL
Interval 32.7 to 43.7
|
|
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Fimbriae Types 2 and 3 [Post, N=324, 378]
|
779 EU/mL
Interval 720.0 to 843.0
|
1015 EU/mL
Interval 894.0 to 1154.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean concentrations were assessed in the per-protocol population.
Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=324 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=381 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Anti-Tetanus [Pre, N = 324, 379]
|
0.835 IU/mL
Interval 0.754 to 0.924
|
0.778 IU/mL
Interval 0.679 to 0.892
|
|
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Anti-Tetanus [Post, N = 324, 381]
|
8.79 IU/mL
Interval 8.06 to 9.59
|
9.64 IU/mL
Interval 8.73 to 10.7
|
|
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Anti-Diphtheria [Pre, N = 324, 381]
|
0.283 IU/mL
Interval 0.235 to 0.341
|
0.198 IU/mL
Interval 0.163 to 0.24
|
|
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Anti-Diphtheria [Post, N = 324, 381]
|
4.06 IU/mL
Interval 3.49 to 4.71
|
2.74 IU/mL
Interval 2.36 to 3.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: \> 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.
Outcome measures
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=361 Participants
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=407 Participants
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Pain [N = 352, 404]
|
309 Participants
|
341 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Pain [N = 352, 404]
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Erythema [N = 351, 404]
|
81 Participants
|
120 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Erythema [N = 351, 404]
|
7 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Swelling [N= 352, 403]
|
72 Participants
|
94 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Swelling [N= 352, 403]
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Fever [N = 356, 405]
|
15 Participants
|
20 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Fever [N = 356, 405]
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Headache [N = 350, 404]
|
142 Participants
|
152 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Headache [N = 350, 404]
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Malaise [N = 350, 404]
|
103 Participants
|
117 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Malaise [N = 350, 404]
|
7 Participants
|
8 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Any Myalgia [N = 351, 404]
|
211 Participants
|
216 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Grade 3 Myalgia [N = 351, 404]
|
8 Participants
|
6 Participants
|
Adverse Events
Group 1: Previous Tdap or Tdap-IPV Recipients
Serious events: 3 serious events
Other events: 309 other events
Deaths: 0 deaths
Group 2: Tdap Vaccine-naïve
Serious events: 1 serious events
Other events: 341 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=361 participants at risk
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=407 participants at risk
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Arnold-Chiari Malformation
|
0.28%
1/361 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
0.00%
0/407 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
General disorders
Death
|
0.00%
0/361 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
0.25%
1/407 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.28%
1/361 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
0.00%
0/407 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Reproductive system and breast disorders
Vaginal Haematoma
|
0.28%
1/361 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
0.00%
0/407 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
Other adverse events
| Measure |
Group 1: Previous Tdap or Tdap-IPV Recipients
n=361 participants at risk
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
|
Group 2: Tdap Vaccine-naïve
n=407 participants at risk
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
|
|---|---|---|
|
General disorders
Solicited Injection Site Pain
|
87.8%
309/352 • Number of events 309 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
84.4%
341/404 • Number of events 341 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
General disorders
Solicited Injection Site Erythema
|
23.1%
81/351 • Number of events 81 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
29.7%
120/404 • Number of events 120 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
General disorders
Malaise
|
29.4%
103/350 • Number of events 103 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
29.0%
117/404 • Number of events 117 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
General disorders
Solicited Injection Site Swelling
|
20.5%
72/351 • Number of events 72 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
23.3%
94/403 • Number of events 94 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
60.1%
211/351 • Number of events 211 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
53.5%
216/404 • Number of events 216 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Nervous system disorders
Headache
|
3.6%
13/361 • Number of events 13 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
8.8%
36/407 • Number of events 36 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.9%
14/361 • Number of events 14 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
5.4%
22/407 • Number of events 23 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
30/361 • Number of events 31 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
5.7%
23/407 • Number of events 23 • Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
|
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