Trial Outcomes & Findings for Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan (NCT NCT00258908)
NCT ID: NCT00258908
Last Updated: 2016-04-14
Results Overview
Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
115 participants
Primary outcome timeframe
Day 0 and Day 28 Post-vaccination
Results posted on
2016-04-14
Participant Flow
Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan
A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.
Participant milestones
| Measure |
ADACEL™ Group
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
Baseline characteristics by cohort
| Measure |
ADACEL™ Group
n=112 Participants
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Age, Categorical
<=18 years
|
112 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.8 years
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 Post-vaccinationPopulation: Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population
Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
Outcome measures
| Measure |
ADACEL™ Group
n=112 Participants
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-diphtheria (≥ 0.01 IU/mL, Day 0)
|
95 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-diphtheria (≥ 0.01 IU/mL, Day 28)
|
99 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-diphtheria (≥ 0.1 IU/mL, Day 0)
|
55 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-diphtheria (≥ 0.1 IU/mL, Day 28)
|
99 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-tetanus (≥ 0.01 IU/mL, Day 0)
|
100 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-tetanus (≥ 0.01 IU/mL, Day 28)
|
100 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-tetanus (≥ 0.1 IU/mL, Day 0)
|
90 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-tetanus (≥ 0.1 IU/mL, Day 28)
|
100 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-pertussis toxoid (≥4-fold rise, Day 28)
|
88 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-Filamentous Haemagglutinin ≥4-fold rise Day28
|
88 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-Fimbriae Types 2 & 3 (≥4-fold rise, Day 28)
|
87 Percentage of participants
|
|
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Anti-Pertactin (≥4-fold rise, Day 28)
|
99 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.
GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
Outcome measures
| Measure |
ADACEL™ Group
n=112 Participants
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-diphtheria - Day 0
|
0.120 Titers
Interval 0.093 to 0.156
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-diphtheria - Day 28
|
4.87 Titers
Interval 3.67 to 6.47
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-tetanus - Day 0
|
0.386 Titers
Interval 0.311 to 0.479
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-tetanus - Day 28
|
18.8 Titers
Interval 15.9 to 22.2
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-pertussis toxoid - Day 0
|
9.5 Titers
Interval 7.53 to 12.0
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-pertussis toxoid - Day 28
|
189 Titers
Interval 147.0 to 243.0
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Filamentous Haemagglutinin - Day 0
|
16.7 Titers
Interval 13.1 to 21.4
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Filamentous Haemagglutinin - Day 28
|
234 Titers
Interval 203.0 to 269.0
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Fimbriae Types 2 and 3 - Day 0
|
31.2 Titers
Interval 24.8 to 39.1
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Fimbriae Types 2 and 3 - Day 28
|
940 Titers
Interval 697.0 to 1268.0
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Pertactin - Day 0
|
8.89 Titers
Interval 7.02 to 11.3
|
|
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Anti-Pertactin - Day 28
|
312 Titers
Interval 251.0 to 388.0
|
SECONDARY outcome
Timeframe: Within 8 days of vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose
Outcome measures
| Measure |
ADACEL™ Group
n=112 Participants
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Malaise (prevents daily activities)
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any solicited injection site reaction
|
67 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Injection site pain
|
59 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Gd3 Injection site pain(inj limb movement reduced)
|
4 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Injection site erythema
|
33 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Injection site erythema (≥ 5 cm)
|
6 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Injection site swelling
|
37 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Injection site swelling (≥ 5 cm)
|
5 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any solicited systemic reaction
|
58 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Fever
|
10 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Fever (≥ 39.0 °C)
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Headache
|
17 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Headache (prevents daily activities)
|
1 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Malaise
|
31 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Any Myalgia
|
53 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Grade 3 Myalgia (prevents daily activities)
|
1 Percentage of Participants
|
Adverse Events
ADACEL™ Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADACEL™ Group
n=112 participants at risk
Participants received 1 dose of ADACEL™ (TdcP vaccine)
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.9%
10/112 • Number of events 11 • Adverse events data were collected from day of vaccination to 28 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