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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult
• Intervention / Treatment: Biological: REPEVAX® after REVAXIS®; Biological: REPEVAX® after Placebo

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
  • Lyon, France
  • Montpellier, France
  • Paris, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2006
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: November 15, 2006
• First Submitted That Met QC Criteria: November 15, 2006
• First Posted (Estimate): November 16, 2006

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: F06-Td5I-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No