Trial Outcomes & Findings for Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China (NCT NCT01933776)
NCT ID: NCT01933776
Last Updated: 2016-03-07
Results Overview
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 0 up to Day 28 post-vaccination
Results posted on
2016-03-07
Participant Flow
The study participants were enrolled from 27 August 2013 through 08 October 2013 at 1 clinic center in China.
A total of 40 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
Participant milestones
| Measure |
ADACEL™ Vaccine Group 1 (Adults)
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
ADACEL™ Vaccine Group 2 (Children)
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China
Baseline characteristics by cohort
| Measure |
ADACEL™ Vaccine Group 1
n=20 Participants
Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
ADACEL™ Vaccine Group 2
n=20 Participants
Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
20 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
|
44.2 Years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
5.8 Years
STANDARD_DEVIATION 1.1 • n=107 Participants
|
25.0 Years
STANDARD_DEVIATION 21.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 28 post-vaccinationPopulation: Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Outcome measures
| Measure |
ADACEL™ Vaccine Group 1
n=20 Participants
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
ADACEL™ Vaccine Group 2
n=20 Participants
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Erythema
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Swelling
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Headache
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Malaise
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Serious adverse events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Outcome measures
| Measure |
ADACEL™ Vaccine Group 1
n=20 Participants
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
ADACEL™ Vaccine Group 2
n=20 Participants
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Injection site Pain
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Injection site Erythema
|
1 Participants
|
9 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Erythema
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Injection site Swelling
|
3 Participants
|
9 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Injection site Swelling
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Fever
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Headache
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Headache
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Malaise
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Malaise
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Myalgia
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
Adverse Events
ADACEL™ Vaccine Group 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ADACEL™ Vaccine Group 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADACEL™ Vaccine Group 1
n=20 participants at risk
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
ADACEL™ Vaccine Group 2
n=20 participants at risk
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Pain
|
30.0%
6/20 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
45.0%
9/20 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Erythema
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
45.0%
9/20 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site Swelling
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
45.0%
9/20 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Fever
|
0.00%
0/20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) 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