Safety of REPEVAX® Given One Month After REVAXIS®
|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: NCT00400309|
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : September 11, 2017
- To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.
- To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
- To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adult||Biological: REPEVAX® after REVAXIS® Biological: REPEVAX® after Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults|
|Actual Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
Experimental: REPEVAX® after REVAXIS®
REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
Biological: REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
Active Comparator: REPEVAX® after Placebo
Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
Biological: REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
- injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. [ Time Frame: 7 days ]
- injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309
|Study Director:||Medical Director||Sanofi Pasteur, a Sanofi Company|