NCT00400309

Safety of REPEVAX® Given One Month After REVAXIS®

A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Primary objective: * 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. Secondary objectives: * 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.

Conditions

• Healthy Adult

Interventions

Type	Name	Description
BIOLOGICAL	REPEVAX® after REVAXIS®	Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
BIOLOGICAL	REPEVAX® after Placebo	Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-11-16
• Last updated: 2017-09-11

Locations

4 sites across 1 country: France