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Trial record 1 of 1 for:    Td527
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Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China

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ClinicalTrials.gov Identifier: NCT01933776
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : April 21, 2014
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Intervention Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap
Enrollment 40
Recruitment Details The study participants were enrolled from 27 August 2013 through 08 October 2013 at 1 clinic center in China.
Pre-assignment Details A total of 40 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
Arm/Group Title ADACEL™ Vaccine Group 1 (Adults) ADACEL™ Vaccine Group 2 (Children)
Hide Arm/Group Description Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™) Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2 Total
Hide Arm/Group Description Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™) Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™) Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
20
 100.0%
20
  50.0%
Between 18 and 65 years
20
 100.0%
0
   0.0%
20
  50.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
44.2  (14.4) 5.8  (1.1) 25.0  (21.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
10
  50.0%
14
  70.0%
24
  60.0%
Male
10
  50.0%
6
  30.0%
16
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Hide Description

Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.

Time Frame Day 0 up to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2
Hide Arm/Group Description:
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Grade 3 Injection site Pain 0 0
Grade 3 Injection site Erythema 0 3
Grade 3 Injection site Swelling 0 3
Grade 3 Fever 0 0
Grade 3 Headache 0 0
Grade 3 Malaise 0 0
Grade 3 Myalgia 0 0
Serious adverse events 0 0
2.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Hide Description

Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; 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 reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2
Hide Arm/Group Description:
Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 6 9
Grade 3 Injection site Pain 0 0
Injection site Erythema 1 9
Grade 3 Injection site Erythema 0 3
Injection site Swelling 3 9
Grade 3 Injection site Swelling 0 3
Fever 0 3
Grade 3 Fever 0 0
Headache 1 1
Grade 3 Headache 0 0
Malaise 0 0
Grade 3 Malaise 0 0
Myalgia 1 1
Grade 3 Myalgia 0 0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2
Hide Arm/Group Description Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™) Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
All-Cause Mortality
ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADACEL™ Vaccine Group 1 ADACEL™ Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (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 1 ADACEL™ Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      9/20 (45.00%)    
General disorders     
Injection site Pain  1  6/20 (30.00%)  6 9/20 (45.00%)  9
Injection site Erythema  1  1/20 (5.00%)  1 9/20 (45.00%)  9
Injection site Swelling  1  3/20 (15.00%)  3 9/20 (45.00%)  9
Fever  1  0/20 (0.00%)  0 3/20 (15.00%)  3
Infections and infestations     
Upper respiratory tract infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/20 (5.00%)  1 1/20 (5.00%)  1
Nervous system disorders     
Headache  1  1/20 (5.00%)  1 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 16.0
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01933776     History of Changes
Other Study ID Numbers: Td527
U1111-1127-7738 ( Other Identifier: WHO )
First Submitted: August 28, 2013
First Posted: September 2, 2013
Results First Submitted: March 17, 2014
Results First Posted: April 21, 2014
Last Update Posted: March 7, 2016