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Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

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ClinicalTrials.gov Identifier: NCT01629589
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : October 21, 2013
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Tetanus
Diphtheria
Pertussis
Whooping Cough
Interventions Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
Enrollment 423
Recruitment Details The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.
Pre-assignment Details A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description Participants received a single dose of Adacel® vaccine Participants received a single dose of BOOSTRIX® vaccine
Period Title: Overall Study
Started 212 211
Completed 204 [1] 204
Not Completed 8 7
Reason Not Completed
Protocol Violation             4             2
Lost to Follow-up             2             1
Withdrawal by Subject             2             3
Did not receive study vaccine             0             1
[1]
A participant received the Boostrix vaccine. Study data reported for the Boostrix vaccine group.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group Total
Hide Arm/Group Description Participants received a single dose of Adacel® vaccine Participants received a single dose of BOOSTRIX® vaccine Total of all reporting groups
Overall Number of Baseline Participants 212 211 423
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 211 participants 423 participants
<=18 years
212
 100.0%
211
 100.0%
423
 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 212 participants 211 participants 423 participants
11.6  (0.5) 11.6  (0.5) 11.6  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 211 participants 423 participants
Female
105
  49.5%
106
  50.2%
211
  49.9%
Male
107
  50.5%
105
  49.8%
212
  50.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 212 participants 211 participants 423 participants
212 211 423
1.Primary Outcome
Title Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
Time Frame Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 196 194
Measure Type: Number
Unit of Measure: Participants
Tetanus (pre-vaccination) ≥0.1 IU/mL 172 177
Tetanus (post-vaccination) ≥0.1 IU/mL 196 194
Diphtheria (pre-vaccination) ≥0.1 IU/mL 135 139
Diphtheria (post-vaccination) ≥ 0.1 IU/mL 196 194
Tetanus (pre-vaccination) ≥ 1.0 IU/mL 33 48
Tetanus (post-vaccination) ≥ 1.0 IU/mL 195 194
Diphtheria (pre-vaccination) ≥1.0 IU/mL 28 26
Diphtheria (post-vaccination) ≥1.0 IU/mL 183 186
2.Secondary Outcome
Title Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test
Time Frame Day 0 (pre-vaccination) to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 196 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Tetanus (pre-vaccination)
0.422
(0.363 to 0.492)
0.456
(0.393 to 0.528)
Tetanus (post-vaccination)
18.9
(16.4 to 21.8)
9.18
(8.10 to 10.4)
Diphtheria (pre-vaccination)
0.211
(0.171 to 0.260)
0.221
(0.181 to 0.269)
Diphtheria (post-vaccination)
8.17
(6.83 to 9.77)
5.62
(4.85 to 6.51)
3.Secondary Outcome
Title Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description

Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.

Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 196 194
Measure Type: Number
Unit of Measure: Participants
Tetanus 194 191
Diphtheria 189 188
4.Secondary Outcome
Title Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)
Time Frame Day 0 (pre-vaccination) to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 196 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pertussis toxoid (pre-vaccination)
5.59
(4.67 to 6.68)
5.69
(4.71 to 6.88)
Pertussis toxoid (post-vaccination)
31.0
(27.0 to 35.7)
44.1
(39.0 to 49.9)
Filamentous hemagglutinin (pre-vaccination)
22.7
(19.0 to 27.2)
22.7
(19.4 to 26.6)
Filamentous hemagglutinin (post-vaccination)
255
(228 to 286)
318
(292 to 347)
Pertactin (pre-vaccination)
12.3
(10.5 to 14.4)
10.3
(8.99 to 11.9)
Pertactin (post-vaccination)
263
(223 to 310)
252
(214 to 295)
Fimbriae types 2 and 3 (pre-vaccination)
5.95
(4.88 to 7.24)
6.55
(5.33 to 8.04)
Fimbriae types 2 and 3 (post-vaccination)
346
(269 to 446)
11.1
(8.79 to 14.0)
5.Secondary Outcome
Title Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description

Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.

Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 196 194
Measure Type: Number
Unit of Measure: Participants
Pertussis toxoid 97 142
Filamentous hemagglutinin 167 189
Pertactin 186 189
Fimbriae types 2 and 3 181 31
6.Secondary Outcome
Title Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Hide Description The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.
Time Frame Up to 15 minutes post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description:
Participants received a single dose of Adacel® vaccine
Participants received a single dose of BOOSTRIX® vaccine
Overall Number of Participants Analyzed 211 211
Measure Type: Number
Unit of Measure: Participants
Headache 1 0
Nausea 1 0
Time Frame Adverse event data were collected from Day 0 up to Day 28 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Hide Arm/Group Description Participants received a single dose of Adacel® vaccine Participants received a single dose of BOOSTRIX® vaccine
All-Cause Mortality
Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/211 (0.00%)      0/211 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Adacel® Vaccine Group BOOSTRIX® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/211 (27.49%)      70/211 (33.18%)    
General disorders     
Injection Site Pain  1  34/211 (16.11%)  36 43/211 (20.38%)  46
Nervous system disorders     
Headache  1  21/211 (9.95%)  26 31/211 (14.69%)  39
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Pain  1  11/211 (5.21%)  11 4/211 (1.90%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01629589     History of Changes
Other Study ID Numbers: Td551
U1111-1127-6774 ( Other Identifier: WHO )
First Submitted: June 22, 2012
First Posted: June 27, 2012
Results First Submitted: August 16, 2013
Results First Posted: October 21, 2013
Last Update Posted: March 2, 2016