Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TD532
Previous Study | Return to List | Next Study

A Study to Assess the Safety of Adacel® Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01040052
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : March 29, 2011
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Intervention Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
Enrollment 30
Recruitment Details Participants were enrolled from 06 to 13 December 2009 in 1 medical center in Vietnam.
Pre-assignment Details A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.
Arm/Group Title ADACEL® Vaccine Group
Hide Arm/Group Description All participants received a single dose of ADACEL® vaccine on Day 0.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title ADACEL® Vaccine Group
Hide Arm/Group Description All participants received a single dose of ADACEL® vaccine on Day 0.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
35.1  (5.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Vietnam Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Hide Description Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).
Time Frame Days 0-7 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® Vaccine Group
Hide Arm/Group Description:
All participants received a single dose of ADACEL® vaccine on Day 0.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 27
Any Injection Site Pain 27
Grade 3 Inj. site pain (hindered daily activities) 0
Any Itchiness 1
Grade 3 Itchiness (hindered daily activities) 0
Any Erythema 1
Grade 3 Erythema (hindered daily activities) 0
Any Swelling 1
Grade 3 Swelling (hindered daily activities) 0
Any Solicited Systemic Reaction 5
Any Headache 2
Grade 3 Headache (hindered daily activities) 0
Any Body Ache or Muscle Weakness 1
Grade 3 Body Ache or Muscle Weakness 0
Any Tiredness 4
Grade 3 Tiredness (hinders daily activities) 0
Any Chills 1
Grade 3 Chills (hinders daily activities) 0
Any Nausea 0
Grade 3 Nausea (hinders daily activities) 0
Any Vomiting 0
Grade 3 Vomiting (hinders daily activities) 0
Any Rash 0
Grade 3 Rash (hinders daily activities) 0
Any Itchiness 0
Grade 3 Itchiness (hinders daily activities) 0
Any Anorexia 1
Grade 3 Anorexia (hinders daily activities) 0
Any Sore and Swollen Joints 0
Gr 3 Sore and Swollen Joints (hinders activities) 0
Any Diarrhea 0
Grade 3 Diarrhea (hinders daily activities) 0
Any Lymph Node Swelling 0
Grade 3 Lymph Node Swelling (hinders activities) 0
Any Fever 1
Grade Fever (hinders daily activities) 0
Time Frame Adverse events data were collected from the day of vaccination up to 30 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADACEL® Vaccine Group
Hide Arm/Group Description All participants received a single dose of ADACEL® vaccine on Day 0.
All-Cause Mortality
ADACEL® Vaccine Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADACEL® Vaccine Group
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADACEL® Vaccine Group
Affected / at Risk (%) # Events
Total   27/30 (90.00%)    
General disorders   
Tiredeness  1  4/30 (13.33%)  4
Injection site pain  1  27/30 (90.00%)  27
Nervous system disorders   
Headache  1  2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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: NCT01040052     History of Changes
Other Study ID Numbers: TD532
U1111-1111-6093 ( Other Identifier: WHO )
First Submitted: December 21, 2009
First Posted: December 25, 2009
Results First Submitted: March 1, 2011
Results First Posted: March 29, 2011
Last Update Posted: May 16, 2016