Trial Outcomes & Findings for Immunogenicity and Safety of Adacel Polio Vaccine (NCT NCT00797511)
NCT ID: NCT00797511
Last Updated: 2012-11-26
Results Overview
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
132 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2012-11-26
Participant Flow
Participants were enrolled from 24 November 2008 to 11 March 2009 at 1 medical center in Taiwan.
A total of 132 participants who met the inclusion and none of the exclusion criteria were enrolled, vaccinated, and evaluated.
Participant milestones
| Measure |
ADACEL POLIO Vaccine Study Group
Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ADACEL POLIO Vaccine Study Group
Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Immunogenicity and Safety of Adacel Polio Vaccine
Baseline characteristics by cohort
| Measure |
ADACEL POLIO Vaccine Study Group
n=132 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Age, Categorical
<=18 years
|
132 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
|
6.89 Years
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Outcome measures
| Measure |
ADACEL POLIO Vaccine Study Group
n=131 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Diphtheria (Post-vaccination)
|
131 Participants
|
|
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Tetanus (Post-vaccination)
|
131 Participants
|
|
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Polio 1 (Post-vaccination)
|
131 Participants
|
|
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Polio 2 (Post-vaccination)
|
131 Participants
|
|
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Polio 3 (Post-vaccination)
|
131 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Anti-Pertussis concentrations were assessed in the per-protocol population.
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Outcome measures
| Measure |
ADACEL POLIO Vaccine Study Group
n=131 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Pertussis (N = 114)
|
88 Participants
|
|
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Filamentous Hemagglutinin (N = 130)
|
126 Participants
|
|
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Fimbriae types 2 and 3 (N = 130)
|
116 Participants
|
|
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Anti-Pertactin (N = 131)
|
130 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Geometric mean titers were assessed in the per-protocol population.
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
ADACEL POLIO Vaccine Study Group
n=131 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Anti-Diphtheria (Post-vaccination)
|
3.81 Titers
Interval 3.25 to 4.46
|
|
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Anti-Tetanus (Post-vaccination)
|
17.2 Titers
Interval 14.8 to 20.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Anti-Polio 1 (Post-vaccination)
|
9627 Titers
Interval 7960.0 to 11642.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Anti-Polio 2 (Post-vaccination)
|
7083 Titers
Interval 6057.0 to 8282.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Anti-Polio 3 (Post-vaccination)
|
9860 Titers
Interval 8244.0 to 11793.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
ADACEL POLIO Vaccine Study Group
n=131 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Pertussis Toxoid (Pre-vaccination)
|
4.53 Titers
Interval 3.81 to 5.39
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Pertussis Toxoid (Post-vaccination)
|
42.7 Titers
Interval 36.1 to 50.3
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Filamentous hemagglutinin (Pre-vaccination)
|
19.7 Titers
Interval 16.4 to 23.7
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Filamentous hemagglutinin (Post-vaccination)
|
164 Titers
Interval 145.0 to 185.0
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Fimbriae types 2 and 3 (Pre-vaccination)
|
17.5 Titers
Interval 12.8 to 24.0
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Fimbriae types 2 and 3 (Post-vaccination)
|
423 Titers
Interval 291.0 to 614.0
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Pertactin (Pre-vaccination)
|
11.9 Titers
Interval 9.92 to 14.3
|
|
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Anti-Pertactin (Post-vaccination)
|
314 Titers
Interval 263.0 to 376.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 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, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
ADACEL POLIO Vaccine Study Group
n=132 Participants
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Solicited Injection Site Reaction
|
112 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Injection site Erythema (N = 129)
|
61 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Erythema (≥5 cm; N = 129)
|
4 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Injection site Swelling (N = 129)
|
40 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Swelling (≥5 cm; N = 129)
|
2 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any injection site Pain (N = 129)
|
102 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Pain (Incapacitating; N = 129)
|
1 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any extensive swelling of vaccinated limb (N=129)
|
0 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 extensive swelling of vaccinated limb N129
|
0 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Solicited Systemic Reaction (N = 130)
|
63 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Fever (N = 130)
|
14 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Fever (> 39.0°C; N = 130)
|
2 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Headache (N = 130)
|
28 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Headache (Prevents daily activities; N=130
|
1 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Myalgia (N = 130)
|
46 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Myalgia (Prevents daily activities; N=130)
|
0 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Any Malaise (N = 130)
|
27 Participants
|
|
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Grade 3 Malaise (Prevents daily activities; N=130)
|
0 Participants
|
Adverse Events
ADACEL POLIO Vaccine Study Group
Serious events: 2 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADACEL POLIO Vaccine Study Group
n=132 participants at risk
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/132 • Number of events 1 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.76%
1/132 • Number of events 1 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
Other adverse events
| Measure |
ADACEL POLIO Vaccine Study Group
n=132 participants at risk
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
|
|---|---|
|
General disorders
Injection Site Pain
|
77.3%
102/132 • Number of events 102 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
General disorders
Injection site Erythema
|
46.2%
61/132 • Number of events 61 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
General disorders
Fever
|
10.6%
14/132 • Number of events 14 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
General disorders
Malaise
|
20.5%
27/132 • Number of events 27 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
General disorders
Injection Site Swelling
|
30.3%
40/132 • Number of events 40 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.8%
46/132 • Number of events 46 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
Nervous system disorders
Headache
|
21.2%
28/132 • Number of events 28 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
14.4%
19/132 • Number of events 19 • Adverse events data were collected from following vaccination (Day 0) for up to 1 month 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