Trial Outcomes & Findings for Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose (NCT NCT01439165)
NCT ID: NCT01439165
Last Updated: 2022-04-28
Results Overview
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1330 participants
Primary outcome timeframe
1 month post-booster vaccination
Results posted on
2022-04-28
Participant Flow
Study participants were enrolled from 30 November 2011 to 13 August 2015 at 31 clinic sites in the United States and 2 clinic sites in Canada.
A total of 1330 participants who met all inclusion criteria and no exclusion criteria were randomized; 1327 participants were vaccinated.
Participant milestones
| Measure |
Adacel Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Overall Study
STARTED
|
1002
|
328
|
|
Overall Study
COMPLETED
|
981
|
326
|
|
Overall Study
NOT COMPLETED
|
21
|
2
|
Reasons for withdrawal
| Measure |
Adacel Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
Baseline Characteristics
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Baseline characteristics by cohort
| Measure |
Adacel Vaccine
n=1002 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=328 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
Total
n=1330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1002 Participants
n=99 Participants
|
328 Participants
n=107 Participants
|
1330 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
Age Continuous
|
28.9 Years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
29.2 Years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
29 Years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
646 Participants
n=99 Participants
|
212 Participants
n=107 Participants
|
858 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
472 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
270 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
354 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
732 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
976 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 month post-booster vaccinationPopulation: Seroprotection was assessed in the Per Protocol Analysis Set.
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.
Outcome measures
| Measure |
Adacel Vaccine
n=948 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=317 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Percentage of Participants With Diphtheria and Tetanus Seroprotection
Tetanus
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Diphtheria and Tetanus Seroprotection
Diphtheria
|
99.8 Percentage of participants
|
99.4 Percentage of participants
|
PRIMARY outcome
Timeframe: 1 month post-booster vaccinationPopulation: Booster response rates were assessed in the Per Protocol Analysis Set.
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were \> 2.56 IU/mL for diphtheria and \> 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.
Outcome measures
| Measure |
Adacel Vaccine
n=948 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=317 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Percentage of Participants With Diphtheria and Tetanus Booster Response
Tetanus
|
74.5 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Participants With Diphtheria and Tetanus Booster Response
Diphtheria
|
83.2 Percentage of participants
|
84.1 Percentage of participants
|
PRIMARY outcome
Timeframe: 1 month post-booster vaccinationPopulation: Geometric mean concentrations were assessed in the Per Protocol Analysis Set.
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.
Outcome measures
| Measure |
Adacel Vaccine
n=948 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
Pertussis Toxoid
|
102 Concentrations (1/dil)
Interval 94.9 to 110.0
|
—
|
|
Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
FHA
|
209 Concentrations (1/dil)
Interval 200.0 to 217.0
|
—
|
|
Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
Pertactin
|
318 Concentrations (1/dil)
Interval 302.0 to 334.0
|
—
|
|
Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
Fimbriae types 2 and 3
|
745 Concentrations (1/dil)
Interval 711.0 to 781.0
|
—
|
PRIMARY outcome
Timeframe: 1 month post-booster vaccinationPopulation: Booster response rate was assessed in the Per protocol analysis set
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin \[FHA\], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value. Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens.
Outcome measures
| Measure |
Adacel Vaccine
n=948 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Percentage of Subjects With Pertussis Antigen Booster Response
Pertussis Toxoid
|
77.5 Percentage of subjects
|
—
|
|
Percentage of Subjects With Pertussis Antigen Booster Response
FHA
|
68.9 Percentage of subjects
|
—
|
|
Percentage of Subjects With Pertussis Antigen Booster Response
Pertactin
|
65.3 Percentage of subjects
|
—
|
|
Percentage of Subjects With Pertussis Antigen Booster Response
Fimbriae (types 2 and 3)
|
56.8 Percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Outcome measures
| Measure |
Adacel Vaccine
n=999 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=328 Participants
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Injection site Pain
|
87.1 Percentage of participants
|
87.4 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Injection site Pain
|
3.6 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Injection site Erythema
|
6.4 Percentage of participants
|
5.5 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Injection site Erythema
|
0.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Injection site Swelling
|
6.9 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Injection site Swelling
|
0.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Fever
|
0.9 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Fever
|
0.2 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Headache
|
41.4 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Headache
|
2.6 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Malaise
|
33.3 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Malaise
|
3.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Any Myalgia
|
58.1 Percentage of participants
|
58.2 Percentage of participants
|
|
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Grade 3 Myalgia
|
3.0 Percentage of participants
|
3.1 Percentage of participants
|
Adverse Events
Adacel Vaccine
Serious events: 8 serious events
Other events: 855 other events
Deaths: 0 deaths
Td Adsorbed Vaccine
Serious events: 1 serious events
Other events: 284 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adacel Vaccine
n=999 participants at risk
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=328 participants at risk
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Crohn's disease
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Infectious mononucleosis
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/999 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.30%
1/328 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abortion spontaneous
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.10%
1/999 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
0.00%
0/328 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
Other adverse events
| Measure |
Adacel Vaccine
n=999 participants at risk
Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine.
|
Td Adsorbed Vaccine
n=328 participants at risk
Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine).
|
|---|---|---|
|
General disorders
Injection site Pain
|
85.6%
855/999 • Number of events 855 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
86.6%
284/328 • Number of events 284 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
General disorders
Injection site Erythema
|
6.3%
63/999 • Number of events 63 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
5.5%
18/328 • Number of events 18 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
General disorders
Injection site Swelling
|
6.8%
68/999 • Number of events 68 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
7.9%
26/328 • Number of events 26 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Headache
|
40.7%
407/999 • Number of events 407 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
38.7%
127/328 • Number of events 127 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
General disorders
Malaise
|
32.7%
327/999 • Number of events 327 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
30.5%
100/328 • Number of events 100 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.2%
571/999 • Number of events 571 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
57.6%
189/328 • Number of events 189 • Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Adverse Events were assessed in the Safety Analysis Set
|
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