Trial Outcomes & Findings for Study of Adacel® Vaccine Administered to Persons 10 Years of Age (NCT NCT01311557)
NCT ID: NCT01311557
Last Updated: 2016-04-08
Results Overview
Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1302 participants
Primary outcome timeframe
Day 30 post-vaccination
Results posted on
2016-04-08
Participant Flow
Study participants were enrolled from 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.
A total of 1302 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Participants 10 to <11 Years of Age
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Overall Study
STARTED
|
651
|
651
|
|
Overall Study
COMPLETED
|
646
|
645
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Participants 10 to <11 Years of Age
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Overall Study
Serious adverse event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Study of Adacel® Vaccine Administered to Persons 10 Years of Age
Baseline characteristics by cohort
| Measure |
Participants 10 to <11 Years of Age
n=651 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=651 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Total
n=1302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
651 Participants
n=5 Participants
|
651 Participants
n=7 Participants
|
1302 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.5 Years
STANDARD_DEVIATION 0.3 • n=5 Participants
|
11.4 Years
STANDARD_DEVIATION 0.3 • n=7 Participants
|
10.5 Years
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
305 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
620 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
346 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
682 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
651 Participants
n=5 Participants
|
651 Participants
n=7 Participants
|
1302 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in the Per-protocol Analysis Set.
Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=613 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=608 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Anti-Pertussis toxoid (N=577, 566)
|
30.1 Titers (1/dilutions)
Interval 28.0 to 32.4
|
32.0 Titers (1/dilutions)
Interval 29.6 to 34.7
|
|
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Anti-Filamentous hemagglutinin, Day 30(N=613, 608)
|
232 Titers (1/dilutions)
Interval 218.0 to 247.0
|
225 Titers (1/dilutions)
Interval 211.0 to 239.0
|
|
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Anti-Pertactin (N=613, 607)
|
464 Titers (1/dilutions)
Interval 426.0 to 506.0
|
444 Titers (1/dilutions)
Interval 408.0 to 482.0
|
|
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Anti-Fimbriae types 2 & 3 (N=606, 605)
|
477 Titers (1/dilutions)
Interval 413.0 to 550.0
|
540 Titers (1/dilutions)
Interval 478.0 to 611.0
|
PRIMARY outcome
Timeframe: 30 days post-vaccinationPopulation: Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.
Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \> 93 EU/mL for PT, \> 170 EU/mL for FHA, \> 115 EU mL for PRN, or \> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=613 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=608 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-filamentous hemagglutinin (N=609, 605)
|
84.2 Percentage of participants
|
84.8 Percentage of participants
|
|
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Pertactin (N=600, 600)
|
98.0 Percentage of participants
|
97.5 Percentage of participants
|
|
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Fimbriae types 2 and 3 (N=583, 585)
|
93.7 Percentage of participants
|
97.1 Percentage of participants
|
|
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Pertussis toxoid (N=554, 549)
|
56.7 Percentage of participants
|
56.1 Percentage of participants
|
PRIMARY outcome
Timeframe: 30 days post-vaccinationPopulation: Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.
Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \> 2.56 EU/mL for diphtheria or \> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=613 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=608 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Tetanus (N=610, 603)
|
98.5 Percentage of participants
|
98.8 Percentage of participants
|
|
Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Diphtheria (N=609, 605)
|
97.7 Percentage of participants
|
98.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and 30 days post-vaccinationPopulation: Seroprotection rates were assessed in the Per Protocol Analysis Set.
Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=613 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=608 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Anti-Tetanus (Pre-vaccination, N=610, 604)
|
90.3 Percentage of participants
|
91.2 Percentage of participants
|
|
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Anti-Tetanus (Post-vaccination, N=613, 607)
|
99.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Anti-Diphtheria (Pre-vaccination, N=610, 605)
|
83.6 Percentage of participants
|
75.9 Percentage of participants
|
|
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Anti-Diphtheria (Post-vaccination, N=612, 608)
|
99.7 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Geometric mean titers were assessed in the Per Protocol Analysis Set.
Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=613 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=608 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Filamentous hemagglutinin Day 0 (N=609, 605)
|
22.1 Titers (1/dilutions)
Interval 20.1 to 24.2
|
20.3 Titers (1/dilutions)
Interval 18.5 to 22.3
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Filamentous hemagglutinin Day 30 (N=613, 608)
|
232 Titers (1/dilutions)
Interval 218.0 to 247.0
|
225 Titers (1/dilutions)
Interval 211.0 to 239.0
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Pertussis toxoid; Day 0 (N = 590, 591)
|
4.96 Titers (1/dilutions)
Interval 4.54 to 5.42
|
4.85 Titers (1/dilutions)
Interval 4.41 to 5.34
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Pertussis toxoid; Day 30 (N = 577, 566)
|
30.1 Titers (1/dilutions)
Interval 28.0 to 32.4
|
32.0 Titers (1/dilutions)
Interval 29.6 to 34.7
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Pertactin; Day 0 (N = 600, 601)
|
15.6 Titers (1/dilutions)
Interval 14.2 to 17.1
|
14.8 Titers (1/dilutions)
Interval 13.5 to 16.2
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Pertactin; Day 30 (N = 613, 607)
|
464 Titers (1/dilutions)
Interval 426.0 to 506.0
|
444 Titers (1/dilutions)
Interval 408.0 to 482.0
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Fimbriae types 2 and 3; Day 0 (N = 590, 587)
|
6.77 Titers (1/dilutions)
Interval 6.05 to 7.57
|
7.07 Titers (1/dilutions)
Interval 6.33 to 7.89
|
|
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Fimbriae types 2 and 3; Day 30 (N = 606, 605)
|
477 Titers (1/dilutions)
Interval 413.0 to 550.0
|
540 Titers (1/dilutions)
Interval 478.0 to 611.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Outcome measures
| Measure |
Participants 10 to <11 Years of Age
n=650 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=649 Participants
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Injection-site Pain (N=644, 645)
|
80.9 Percentage of participants
|
80.9 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Injection-site Pain (N=644, 645)
|
3.3 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Injection-site Erythema (N=644, 645)
|
39.4 Percentage of participants
|
38.4 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Injection-site Erythema (N=644, 645)
|
7.9 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Injection-site Swelling (N=644, 645)
|
35.2 Percentage of participants
|
33.5 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Injection-site Swelling (N=644, 645)
|
8.4 Percentage of participants
|
7.3 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Fever (N=642, 644)
|
1.6 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Fever (N=642, 644)
|
0 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Headache (N=644, 646)
|
33.1 Percentage of participants
|
37.6 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Headache (N=644, 646)
|
2.0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Malaise (N=644, 646)
|
26.2 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Malaise (N=644, 646)
|
1.9 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Myalgia (N=644, 645)
|
49.1 Percentage of participants
|
56.4 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Grade 3 Myalgia (N=644, 645)
|
3.3 Percentage of participants
|
1.7 Percentage of participants
|
Adverse Events
Participants 10 to <11 Years of Age
Serious events: 0 serious events
Other events: 521 other events
Deaths: 0 deaths
Participants 11 to <12 Years of Age
Serious events: 1 serious events
Other events: 522 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants 10 to <11 Years of Age
n=651 participants at risk
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=651 participants at risk
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/651 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
0.15%
1/651 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
Other adverse events
| Measure |
Participants 10 to <11 Years of Age
n=651 participants at risk
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
Participants 11 to <12 Years of Age
n=651 participants at risk
Participants received 1 dose of Adacel® vaccine at Visit 1.
|
|---|---|---|
|
General disorders
Injection-site Pain
|
80.0%
521/651 • Number of events 521 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
80.2%
522/651 • Number of events 522 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
|
General disorders
Injection-site Erythema
|
39.0%
254/651 • Number of events 254 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
38.1%
248/651 • Number of events 248 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
|
General disorders
Injection-site Swelling
|
34.9%
227/651 • Number of events 227 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
33.2%
216/651 • Number of events 216 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
|
Nervous system disorders
Headache
|
32.7%
213/651 • Number of events 213 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
37.3%
243/651 • Number of events 243 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
|
General disorders
Malaise
|
26.0%
169/651 • Number of events 169 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
29.0%
189/651 • Number of events 189 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
48.5%
316/651 • Number of events 316 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
|
55.9%
364/651 • Number of events 364 • Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after 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