Trial Outcomes & Findings for Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine (NCT NCT00347958)
NCT ID: NCT00347958
Last Updated: 2013-12-04
Results Overview
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
545 participants
Primary outcome timeframe
0-14 days post-vaccination
Results posted on
2013-12-04
Participant Flow
Participants were enrolled from 21 August 2006, to 12 April 2007, in 6 clinical centers in the US and 6 clinical centers in Canada.
A total of 545 participants were enrolled and vaccinated in the study. Data on 544 participants that met the inclusion and exclusion criteria were analyzed and reported. One participant who did not receive Adacel® vaccine in one of the previous studies was excluded from the Safety Analysis Set.
Participant milestones
| Measure |
Adacel® Vaccine Group
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Overall Study
STARTED
|
544
|
|
Overall Study
COMPLETED
|
540
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Adacel® Vaccine Group
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Baseline characteristics by cohort
| Measure |
Adacel® Vaccine Group
n=544 Participants
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Age, Categorical
<=18 years
|
169 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
368 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
31.7 Years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
284 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
194 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
350 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-14 days post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. The solicited systemic reaction, malaise was not collected in the previous studies.
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=544 Participants
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Solicited Injection Site Reaction
|
89 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Injection Site Pain
|
88 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Injection Site Pain (Incapacitating)
|
2 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Injection Site Erythema/Redness
|
29 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Injection Site Erythema/Redness (≥ 5 cm)
|
3 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Injection Site Swelling
|
26 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Injection Site Swelling (≥ 5 cm)
|
3 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Fever
|
7 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)
|
1 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Headache
|
53 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Headache (Prevents daily activities)
|
3 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Myalgia
|
61 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Myalgia (Prevents daily activities)
|
4 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Any Malaise
|
38 Percentage of Participants
|
|
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Grade 3 Malaise (Prevents daily activities)
|
3 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-vaccinationPopulation: Geometric mean titers were assessed in the per-protocol population.
Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=451 Participants
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Tetanus (IU/mL) Pre-Dose, n = 445
|
1.41 Titers
Interval 1.27 to 1.56
|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Tetanus (IU/mL) Post-Dose, n = 445
|
9.62 Titers
Interval 9.06 to 10.2
|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Diphtheria (IU/mL) no Menactra Pre-Dose, n = 379
|
0.133 Titers
Interval 0.11 to 0.162
|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Diphtheria (IU/mL) no Menactra Post-Dose n = 379
|
2.17 Titers
Interval 1.84 to 2.56
|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Diphtheria (IU/mL) with Menactra Pre-Dose n = 64
|
4.45 Titers
Interval 2.77 to 7.15
|
|
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Diphtheria (IU/mL) with Menactra Post-Dose n = 64
|
8.70 Titers
Interval 6.59 to 11.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-vaccinationPopulation: Geometric mean titers were assessed in the per-protocol population.
Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=451 Participants
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis PT (EU/mL) Pre-Dose, n = 381
|
21.3 Titers
Interval 19.4 to 23.5
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis PT (EU/mL) Post-Dose, n = 425
|
104 Titers
Interval 97.0 to 112.0
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis FHA (EU/mL) Pre-Dose, n = 450
|
34.6 Titers
Interval 31.9 to 37.5
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis FHA (EU/mL) Post-Dose, n = 450
|
201 Titers
Interval 189.0 to 215.0
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis PRN (EU/mL) Pre-Dose, n = 451
|
37.3 Titers
Interval 32.7 to 42.6
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis PRN (EU/mL) Post-Dose, n = 451
|
218 Titers
Interval 201.0 to 236.0
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis FIM (EU/mL) Pre-Dose, n = 445
|
165 Titers
Interval 145.0 to 187.0
|
|
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Pertussis FIM (EU/mL) Post-Dose, n = 450
|
749 Titers
Interval 697.0 to 806.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-vaccinationPopulation: Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.
Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.
Outcome measures
| Measure |
Adacel® Vaccine Group
n=451 Participants
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Diphtheria (IU/mL) without Menactra, Pre-Dose
|
61 Percentage of Participants
|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Tetanus (IU/mL) Pre-Dose
|
96 Percentage of Participants
|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Tetanus (IU/mL) Post-Dose
|
100 Percentage of Participants
|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Diphtheria (IU/mL) without Menactra, Post-Dose
|
95 Percentage of Participants
|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Diphtheria (IU/mL) Menactra, Pre-Dose
|
95 Percentage of Participants
|
|
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Diphtheria (IU/mL) Menactra, Post-Dose
|
100 Percentage of Participants
|
Adverse Events
Adacel® Vaccine Group
Serious events: 7 serious events
Other events: 479 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adacel® Vaccine Group
n=544 participants at risk
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Infections and infestations
Appendicitis
|
0.00%
0/544 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Infections and infestations
Cellulitis
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Infections and infestations
Kidney infection
|
0.00%
0/544 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Metabolism and nutrition disorders
Pyelonephritis
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/544 • Number of events 1 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
Other adverse events
| Measure |
Adacel® Vaccine Group
n=544 participants at risk
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.1%
44/544 • Number of events 45 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.4%
35/544 • Number of events 40 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
General disorders
Injection site pain
|
87.6%
472/539 • Number of events 472 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
General disorders
Injection site erythema/redness
|
28.6%
154/539 • Number of events 154 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
General disorders
Injection site swelling
|
25.6%
138/539 • Number of events 138 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
General disorders
Pyrexia (Fever)
|
6.5%
35/538 • Number of events 35 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Nervous system disorders
Headache
|
53.2%
287/539 • Number of events 287 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
General disorders
Malaise
|
38.2%
206/539 • Number of events 206 • Adverse events data were collected from the day of vaccination to 6 months post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
61.0%
329/539 • Number of events 329 • Adverse events data were collected from the day of vaccination 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