Trial Outcomes & Findings for Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents (NCT NCT01629589)
NCT ID: NCT01629589
Last Updated: 2016-03-02
Results Overview
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
COMPLETED
PHASE4
423 participants
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
2016-03-02
Participant Flow
The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.
A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.
Participant milestones
| Measure |
Adacel® Vaccine Group
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
211
|
|
Overall Study
COMPLETED
|
204
|
204
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Adacel® Vaccine Group
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Did not receive study vaccine
|
0
|
1
|
Baseline Characteristics
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Baseline characteristics by cohort
| Measure |
Adacel® Vaccine Group
n=212 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=211 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
212 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
423 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
|
11.6 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
11.6 Years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
11.6 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
212 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) to Day 28 (post-vaccination)Population: The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
Outcome measures
| Measure |
Adacel® Vaccine Group
n=196 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=194 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (post-vaccination) ≥0.1 IU/mL
|
196 Participants
|
194 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (pre-vaccination) ≥0.1 IU/mL
|
172 Participants
|
177 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (pre-vaccination) ≥0.1 IU/mL
|
135 Participants
|
139 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (post-vaccination) ≥ 0.1 IU/mL
|
196 Participants
|
194 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (pre-vaccination) ≥ 1.0 IU/mL
|
33 Participants
|
48 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (post-vaccination) ≥ 1.0 IU/mL
|
195 Participants
|
194 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (pre-vaccination) ≥1.0 IU/mL
|
28 Participants
|
26 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (post-vaccination) ≥1.0 IU/mL
|
183 Participants
|
186 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) to Day 28 post-vaccinationPopulation: The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test
Outcome measures
| Measure |
Adacel® Vaccine Group
n=196 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=194 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (post-vaccination)
|
18.9 Titers
Interval 16.4 to 21.8
|
9.18 Titers
Interval 8.1 to 10.4
|
|
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (pre-vaccination)
|
0.211 Titers
Interval 0.171 to 0.26
|
0.221 Titers
Interval 0.181 to 0.269
|
|
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus (pre-vaccination)
|
0.422 Titers
Interval 0.363 to 0.492
|
0.456 Titers
Interval 0.393 to 0.528
|
|
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria (post-vaccination)
|
8.17 Titers
Interval 6.83 to 9.77
|
5.62 Titers
Interval 4.85 to 6.51
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>2.56 IU/mL for diphtheria and \>2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer \< LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=196 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=194 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus
|
194 Participants
|
191 Participants
|
|
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Diphtheria
|
189 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) to Day 28 post-vaccinationPopulation: Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.
Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2\&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Adacel® Vaccine Group
n=196 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=194 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertussis toxoid (pre-vaccination)
|
5.59 Titers
Interval 4.67 to 6.68
|
5.69 Titers
Interval 4.71 to 6.88
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertussis toxoid (post-vaccination)
|
31.0 Titers
Interval 27.0 to 35.7
|
44.1 Titers
Interval 39.0 to 49.9
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Filamentous hemagglutinin (pre-vaccination)
|
22.7 Titers
Interval 19.0 to 27.2
|
22.7 Titers
Interval 19.4 to 26.6
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Filamentous hemagglutinin (post-vaccination)
|
255 Titers
Interval 228.0 to 286.0
|
318 Titers
Interval 292.0 to 347.0
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertactin (pre-vaccination)
|
12.3 Titers
Interval 10.5 to 14.4
|
10.3 Titers
Interval 8.99 to 11.9
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertactin (post-vaccination)
|
263 Titers
Interval 223.0 to 310.0
|
252 Titers
Interval 214.0 to 295.0
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Fimbriae types 2 and 3 (pre-vaccination)
|
5.95 Titers
Interval 4.88 to 7.24
|
6.55 Titers
Interval 5.33 to 8.04
|
|
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Fimbriae types 2 and 3 (post-vaccination)
|
346 Titers
Interval 269.0 to 446.0
|
11.1 Titers
Interval 8.79 to 14.0
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>93 EU/mL for PT, \>170 EU/mL for FHA, \>115 EU/mL for PRN, or \>285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer \<LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=196 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=194 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertussis toxoid
|
97 Participants
Interval 45.2 to 60.1
|
142 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Filamentous hemagglutinin
|
167 Participants
Interval 79.4 to 89.9
|
189 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertactin
|
186 Participants
Interval 90.8 to 97.5
|
189 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Fimbriae types 2 and 3
|
181 Participants
Interval 87.7 to 95.7
|
31 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 15 minutes post-vaccinationPopulation: Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.
The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=211 Participants
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=211 Participants
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Headache
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Nausea
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
Adverse Events
Adacel® Vaccine Group
BOOSTRIX® Vaccine Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adacel® Vaccine Group
n=211 participants at risk
Participants received a single dose of Adacel® vaccine
|
BOOSTRIX® Vaccine Group
n=211 participants at risk
Participants received a single dose of BOOSTRIX® vaccine
|
|---|---|---|
|
General disorders
Injection Site Pain
|
16.1%
34/211 • Number of events 36 • Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
|
20.4%
43/211 • Number of events 46 • Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
|
|
Nervous system disorders
Headache
|
10.0%
21/211 • Number of events 26 • Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
|
14.7%
31/211 • Number of events 39 • Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.2%
11/211 • Number of events 11 • Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
|
1.9%
4/211 • Number of events 5 • Adverse event data were collected from Day 0 up to Day 28 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