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Study of Adacel® Vaccine Administered to Persons 10 Years of Age

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ClinicalTrials.gov Identifier: NCT01311557
Recruitment Status : Completed
First Posted : March 9, 2011
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Tetanus
Diphtheria
Pertussis
Intervention Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
Enrollment 1302
Recruitment Details Study participants were enrolled from 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.
Pre-assignment Details A total of 1302 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description Participants received 1 dose of Adacel® vaccine at Visit 1. Participants received 1 dose of Adacel® vaccine at Visit 1.
Period Title: Overall Study
Started 651 651
Completed 646 645
Not Completed 5 6
Reason Not Completed
Serious adverse event             0             1
Protocol Violation             4             2
Lost to Follow-up             0             1
Withdrawal by Subject             1             2
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age Total
Hide Arm/Group Description Participants received 1 dose of Adacel® vaccine at Visit 1. Participants received 1 dose of Adacel® vaccine at Visit 1. Total of all reporting groups
Overall Number of Baseline Participants 651 651 1302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 651 participants 651 participants 1302 participants
<=18 years
651
 100.0%
651
 100.0%
1302
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 651 participants 651 participants 1302 participants
10.5  (0.3) 11.4  (0.3) 10.5  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 651 participants 651 participants 1302 participants
Female
305
  46.9%
315
  48.4%
620
  47.6%
Male
346
  53.1%
336
  51.6%
682
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 651 participants 651 participants 1302 participants
651 651 1302
1.Primary Outcome
Title Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Hide Description Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 613 608
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Anti-Pertussis toxoid (N=577, 566)
30.1
(28.0 to 32.4)
32.0
(29.6 to 34.7)
Anti-Filamentous hemagglutinin, Day 30(N=613, 608)
232
(218 to 247)
225
(211 to 239)
Anti-Pertactin (N=613, 607)
464
(426 to 506)
444
(408 to 482)
Anti-Fimbriae types 2 & 3 (N=606, 605)
477
(413 to 550)
540
(478 to 611)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants 10 to <11 Years of Age, Participants 11 to <12 Years of Age
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments

A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.

The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.

Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.940
Confidence Interval (2-Sided) 95%
0.843 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Participants 10 to <11 Years of Age, Participants 11 to <12 Years of Age
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments

A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.

The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.

Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.944 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Participants 10 to <11 Years of Age, Participants 11 to <12 Years of Age
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments

A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.

The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.

Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.928 to 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Participants 10 to <11 Years of Age, Participants 11 to <12 Years of Age
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.882
Confidence Interval (2-Sided) 95%
0.731 to 1.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Hide Description Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.
Time Frame 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 613 608
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-Pertussis toxoid (N=554, 549) 56.7 56.1
Anti-filamentous hemagglutinin (N=609, 605) 84.2 84.8
Anti-Pertactin (N=600, 600) 98.0 97.5
Anti-Fimbriae types 2 and 3 (N=583, 585) 93.7 97.1
3.Primary Outcome
Title Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine
Hide Description Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.
Time Frame 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 613 608
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-Tetanus (N=610, 603) 98.5 98.8
Anti-Diphtheria (N=609, 605) 97.7 98.0
4.Secondary Outcome
Title Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Hide Description Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.
Time Frame Day 0 (pre-vaccination) and 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection rates were assessed in the Per Protocol Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 613 608
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-Tetanus (Pre-vaccination, N=610, 604) 90.3 91.2
Anti-Tetanus (Post-vaccination, N=613, 607) 99.7 100.0
Anti-Diphtheria (Pre-vaccination, N=610, 605) 83.6 75.9
Anti-Diphtheria (Post-vaccination, N=612, 608) 99.7 100.0
5.Secondary Outcome
Title Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Hide Description Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 613 608
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Anti-Pertussis toxoid; Day 0 (N = 590, 591)
4.96
(4.54 to 5.42)
4.85
(4.41 to 5.34)
Anti-Pertussis toxoid; Day 30 (N = 577, 566)
30.1
(28.0 to 32.4)
32.0
(29.6 to 34.7)
Anti-Filamentous hemagglutinin Day 0 (N=609, 605)
22.1
(20.1 to 24.2)
20.3
(18.5 to 22.3)
Anti-Filamentous hemagglutinin Day 30 (N=613, 608)
232
(218 to 247)
225
(211 to 239)
Anti-Pertactin; Day 0 (N = 600, 601)
15.6
(14.2 to 17.1)
14.8
(13.5 to 16.2)
Anti-Pertactin; Day 30 (N = 613, 607)
464
(426 to 506)
444
(408 to 482)
Anti-Fimbriae types 2 and 3; Day 0 (N = 590, 587)
6.77
(6.05 to 7.57)
7.07
(6.33 to 7.89)
Anti-Fimbriae types 2 and 3; Day 30 (N = 606, 605)
477
(413 to 550)
540
(478 to 611)
6.Secondary Outcome
Title Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Hide Description Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description:
Participants received 1 dose of Adacel® vaccine at Visit 1.
Participants received 1 dose of Adacel® vaccine at Visit 1.
Overall Number of Participants Analyzed 650 649
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain (N=644, 645) 80.9 80.9
Grade 3 Injection-site Pain (N=644, 645) 3.3 2.2
Injection-site Erythema (N=644, 645) 39.4 38.4
Grade 3 Injection-site Erythema (N=644, 645) 7.9 7.4
Injection-site Swelling (N=644, 645) 35.2 33.5
Grade 3 Injection-site Swelling (N=644, 645) 8.4 7.3
Fever (N=642, 644) 1.6 0.6
Grade 3 Fever (N=642, 644) 0 0.2
Headache (N=644, 646) 33.1 37.6
Grade 3 Headache (N=644, 646) 2.0 1.9
Malaise (N=644, 646) 26.2 29.3
Grade 3 Malaise (N=644, 646) 1.9 2.8
Myalgia (N=644, 645) 49.1 56.4
Grade 3 Myalgia (N=644, 645) 3.3 1.7
Time Frame Adverse event data were collected from Day 0 up to Day 30 post-vaccination
Adverse Event Reporting Description Solicited (non serious) adverse events were recorded in diary cards by the study participants or their guardians within 7 days after vaccination.
 
Arm/Group Title Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Hide Arm/Group Description Participants received 1 dose of Adacel® vaccine at Visit 1. Participants received 1 dose of Adacel® vaccine at Visit 1.
All-Cause Mortality
Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/651 (0.00%)      1/651 (0.15%)    
Nervous system disorders     
Cerebrovascular accident * 1  0/651 (0.00%)  0 1/651 (0.15%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Participants 10 to <11 Years of Age Participants 11 to <12 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   521/651 (80.03%)      522/651 (80.18%)    
General disorders     
Injection-site Pain  1  521/651 (80.03%)  521 522/651 (80.18%)  522
Injection-site Erythema  1  254/651 (39.02%)  254 248/651 (38.10%)  248
Injection-site Swelling  1  227/651 (34.87%)  227 216/651 (33.18%)  216
Malaise  1  169/651 (25.96%)  169 189/651 (29.03%)  189
Musculoskeletal and connective tissue disorders     
Myalgia  1  316/651 (48.54%)  316 364/651 (55.91%)  364
Nervous system disorders     
Headache  1  213/651 (32.72%)  213 243/651 (37.33%)  243
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01311557     History of Changes
Other Study ID Numbers: Td519
U1111-1115-6619 ( Other Identifier: WHO )
First Submitted: March 7, 2011
First Posted: March 9, 2011
Results First Submitted: February 2, 2016
Results First Posted: April 8, 2016
Last Update Posted: April 8, 2016