Trial Outcomes & Findings for A Study to Assess the Safety of Adacel® Vaccine (NCT NCT01040052)
NCT ID: NCT01040052
Last Updated: 2016-05-16
Results Overview
Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Days 0-7 Post-vaccination
Results posted on
2016-05-16
Participant Flow
Participants were enrolled from 06 to 13 December 2009 in 1 medical center in Vietnam.
A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.
Participant milestones
| Measure |
ADACEL® Vaccine Group
All participants received a single dose of ADACEL® vaccine on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety of Adacel® Vaccine
Baseline characteristics by cohort
| Measure |
ADACEL® Vaccine Group
n=30 Participants
All participants received a single dose of ADACEL® vaccine on Day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
35.1 Years
STANDARD_DEVIATION 5.82 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Region of Enrollment
Vietnam
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Days 0-7 Post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).
Outcome measures
| Measure |
ADACEL® Vaccine Group
n=30 Participants
All participants received a single dose of ADACEL® vaccine on Day 0.
|
|---|---|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Body Ache or Muscle Weakness
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Body Ache or Muscle Weakness
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Tiredness
|
4 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Tiredness (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Chills
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Chills (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Nausea
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Nausea (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Vomiting
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Vomiting (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Rash
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Rash (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Itchiness
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Itchiness (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Anorexia
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Anorexia (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Sore and Swollen Joints
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Gr 3 Sore and Swollen Joints (hinders activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Diarrhea
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Diarrhea (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Lymph Node Swelling
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Lymph Node Swelling (hinders activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Fever
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade Fever (hinders daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Solicited Injection Site Reaction
|
27 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Injection Site Pain
|
27 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Inj. site pain (hindered daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Itchiness (hindered daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Erythema
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Erythema (hindered daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Swelling
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Swelling (hindered daily activities)
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Solicited Systemic Reaction
|
5 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Any Headache
|
2 Participants
|
|
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Grade 3 Headache (hindered daily activities)
|
0 Participants
|
Adverse Events
ADACEL® Vaccine Group
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADACEL® Vaccine Group
n=30 participants at risk
All participants received a single dose of ADACEL® vaccine on Day 0.
|
|---|---|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from the day of vaccination up to 30 days post-vaccination.
|
|
General disorders
Tiredeness
|
13.3%
4/30 • Number of events 4 • Adverse events data were collected from the day of vaccination up to 30 days post-vaccination.
|
|
General disorders
Injection site pain
|
90.0%
27/30 • Number of events 27 • Adverse events data were collected from the day of vaccination up to 30 days 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