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Trial record 1 of 1 for:    TD525
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Immunogenicity and Safety of Adacel Polio Vaccine

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ClinicalTrials.gov Identifier: NCT00797511
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Poliomyelitis
Intervention Biological: TdcP-IPV vaccine
Enrollment 132
Recruitment Details Participants were enrolled from 24 November 2008 to 11 March 2009 at 1 medical center in Taiwan.
Pre-assignment Details A total of 132 participants who met the inclusion and none of the exclusion criteria were enrolled, vaccinated, and evaluated.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
Period Title: Overall Study
Started 132
Completed 131
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
<=18 years
132
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
6.89  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
64
  48.5%
Male
68
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 132 participants
132
1.Primary Outcome
Title Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Hide Description

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).

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description:
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: Participants
Anti-Diphtheria (Post-vaccination) 131
Anti-Tetanus (Post-vaccination) 131
Anti-Polio 1 (Post-vaccination) 131
Anti-Polio 2 (Post-vaccination) 131
Anti-Polio 3 (Post-vaccination) 131
2.Primary Outcome
Title Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Hide Description 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.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Pertussis concentrations were assessed in the per-protocol population.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description:
Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: Participants
Anti-Pertussis (N = 114) 88
Anti-Filamentous Hemagglutinin (N = 130) 126
Anti-Fimbriae types 2 and 3 (N = 130) 116
Anti-Pertactin (N = 131) 130
3.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Hide Description Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the per-protocol population.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description:
Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
Overall Number of Participants Analyzed 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Diphtheria (Post-vaccination)
3.81
(3.25 to 4.46)
Anti-Tetanus (Post-vaccination)
17.2
(14.8 to 20.0)
Anti-Polio 1 (Post-vaccination)
9627
(7960 to 11642)
Anti-Polio 2 (Post-vaccination)
7083
(6057 to 8282)
Anti-Polio 3 (Post-vaccination)
9860
(8244 to 11793)
4.Primary Outcome
Title Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Hide Description 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).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description:
Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
Overall Number of Participants Analyzed 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Pertussis Toxoid (Pre-vaccination)
4.53
(3.81 to 5.39)
Anti-Pertussis Toxoid (Post-vaccination)
42.7
(36.1 to 50.3)
Anti-Filamentous hemagglutinin (Pre-vaccination)
19.7
(16.4 to 23.7)
Anti-Filamentous hemagglutinin (Post-vaccination)
164
(145 to 185)
Anti-Fimbriae types 2 and 3 (Pre-vaccination)
17.5
(12.8 to 24.0)
Anti-Fimbriae types 2 and 3 (Post-vaccination)
423
(291 to 614)
Anti-Pertactin (Pre-vaccination)
11.9
(9.92 to 14.3)
Anti-Pertactin (Post-vaccination)
314
(263 to 376)
5.Secondary Outcome
Title Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Hide Description 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.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description:
Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 112
Any Injection site Erythema (N = 129) 61
Grade 3 Erythema (≥5 cm; N = 129) 4
Any Injection site Swelling (N = 129) 40
Grade 3 Swelling (≥5 cm; N = 129) 2
Any injection site Pain (N = 129) 102
Grade 3 Pain (Incapacitating; N = 129) 1
Any extensive swelling of vaccinated limb (N=129) 0
Grade 3 extensive swelling of vaccinated limb N129 0
Any Solicited Systemic Reaction (N = 130) 63
Any Fever (N = 130) 14
Grade 3 Fever (> 39.0°C; N = 130) 2
Any Headache (N = 130) 28
Grade 3 Headache (Prevents daily activities; N=130 1
Any Myalgia (N = 130) 46
Grade 3 Myalgia (Prevents daily activities; N=130) 0
Any Malaise (N = 130) 27
Grade 3 Malaise (Prevents daily activities; N=130) 0
Time Frame Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADACEL POLIO Vaccine Study Group
Hide Arm/Group Description Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
All-Cause Mortality
ADACEL POLIO Vaccine Study Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADACEL POLIO Vaccine Study Group
Affected / at Risk (%) # Events
Total   2/132 (1.52%)    
Infections and infestations   
Gastroenteritis * 1  1/132 (0.76%)  1
Injury, poisoning and procedural complications   
Thermal burn * 1  1/132 (0.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADACEL POLIO Vaccine Study Group
Affected / at Risk (%) # Events
Total   102/132 (77.27%)    
General disorders   
Injection Site Pain  1  102/132 (77.27%)  102
Injection site Erythema  1  61/132 (46.21%)  61
Fever  1  14/132 (10.61%)  14
Malaise  1  27/132 (20.45%)  27
Injection Site Swelling * 1  40/132 (30.30%)  40
Infections and infestations   
Nasopharyngitis * 1  19/132 (14.39%)  19
Musculoskeletal and connective tissue disorders   
Myalgia  1  46/132 (34.85%)  46
Nervous system disorders   
Headache  1  28/132 (21.21%)  28
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00797511     History of Changes
Other Study ID Numbers: TD525
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: October 24, 2012
Results First Posted: November 26, 2012
Last Update Posted: November 26, 2012