Safety of REPEVAX® Given One Month After REVAXIS®

Healthy Adult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400309
• Other study ID #: F06-Td5I-301
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2006
• Last updated: September 8, 2017
• Start date: June 2006
• Est. completion date: February 2007

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.

• Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.

Exclusion Criteria:

• Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine

• Any current (= 3 days) significant underlying disease or acute febrile illness (oral temperature =37.5°C)

• Known immunological deficiency

• Known malignant disease

• Known neurological disorder

• Any long-term (= 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days

• Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection

• Any previous (= 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3

• Any recent administration (= 30 days) of a vaccine or scheduled vaccination

Related Conditions & MeSH terms

• Healthy Adult

Intervention

Biological:
• REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
• REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.		7 days
Secondary	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		14 days