Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TRI05
Previous Study | Return to List | Next Study

Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis 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: NCT00304265
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : April 7, 2011
Last Update Posted : April 14, 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 Pertussis
Diphtheria
Tetanus
Poliomyelitis
Intervention Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Enrollment 215
Recruitment Details Participants were enrolled from February 2006 to July 2006 at 17 clinical sites in Germany.
Pre-assignment Details A total of 214 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. One over aged participant was also vaccinated and included in the safety analysis.
Arm/Group Title 6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Hide Arm/Group Description Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
Period Title: Overall Study
Started 117 98
Completed 117 98
Not Completed 0 0
Arm/Group Title 6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group Total
Hide Arm/Group Description Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents. Total of all reporting groups
Overall Number of Baseline Participants 117 98 215
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 98 participants 215 participants
<=18 years
117
 100.0%
98
 100.0%
215
 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 (Full Range)
Unit of measure:  Years
Number Analyzed 117 participants 98 participants 215 participants
12.3
(11 to 13)
12.6
(10 to 16)
12.4
(10 to 16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 98 participants 215 participants
Female
55
  47.0%
37
  37.8%
92
  42.8%
Male
62
  53.0%
61
  62.2%
123
  57.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 117 participants 98 participants 215 participants
117 98 215
1.Primary Outcome
Title Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Hide Description

Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.

Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Time Frame Days 0 to 14 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 6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Hide Arm/Group Description:
Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
Overall Number of Participants Analyzed 117 97
Measure Type: Number
Unit of Measure: Participants
Any Local Reactions After Vaccination 89 87
Any Pain 85 87
Grade 3 Pain (Incapacitating) 7 8
Any Erythema 19 27
Grade 3 Erythema (> 5.0 cm) 10 10
Any Swelling 24 17
Grade 3 Swelling (> 5.0 cm) 6 8
Any Increase in Arm Circumference 8 11
Grade 3 Increase in Arm Circumference (> 5.0 cm) 0 0
Any Systemic Reactions After Vaccination 85 84
Fever 5 15
Any Headache 40 50
Grade 3 Headache (Prevents Daily Activities) 4 5
Any Malaise 40 44
Grade 3 Malaise (Prevents Daily Activities) 2 2
Any Myalgia 69 73
Grade 3 Myalgia (Prevents Daily Activity) 5 10
Time Frame Adverse event data were collected for 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Hide Arm/Group Description Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
All-Cause Mortality
6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/117 (0.00%)   0/98 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
6th Dose Pertussis Vaccine Group 5th Dose Pertussis Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   89/117 (76.07%)   87/97 (89.69%) 
General disorders     
Injection site pain  1  89/117 (76.07%)  87/97 (89.69%) 
Injection site erythema  1  19/117 (16.24%)  27/97 (27.84%) 
Injection site swelling  1  24/117 (20.51%)  17/97 (17.53%) 
Malaise  1  40/117 (34.19%)  44/97 (45.36%) 
Pyrexia  1  5/117 (4.27%)  15/97 (15.46%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  69/117 (58.97%)  73/97 (75.26%) 
Nervous system disorders     
Headache  1  40/117 (34.19%)  50/97 (51.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00304265     History of Changes
Other Study ID Numbers: TRI05
First Submitted: March 16, 2006
First Posted: March 17, 2006
Results First Submitted: February 10, 2011
Results First Posted: April 7, 2011
Last Update Posted: April 14, 2016