Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years

Primary objective:

  • To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
  • To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

  • If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
  • To describe the immune responses to REPEVAX in these subjects
  • To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Sanofi Pasteur MSD Investigational Site
      • Lille, France
        • Sanofi Pasteur MSD Investigational Site
      • Montpellier, France
        • Sanofi Pasteur MSD Investigational Site
      • Paris, France
        • Sanofi Pasteur MSD Investigational Site
      • Poitiers, France
        • Sanofi Pasteur MSD Investigational Site
      • Saint-Etienne, France
        • Sanofi Pasteur MSD Investigational Site
  • Germany
      • Balve, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Berlin, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Dülmen, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Nürnberg, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Offenbach, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Rodgau, Germany
        • Sanofi Pasteur MSD Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged ≥40 years
  • No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years

Exclusion Criteria:

  • Medically diagnosed pertussis disease within the last 10 years
  • Receipt of medication / vaccine that may interfere with study assessments
  • Febrile illness or moderate or severe acute illness/infection
  • Know pregnancy
  • History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
  • History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
  • History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
  • Known or suspected immune dysfunction
  • Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
  • Chronic disease or intercurrent illness that might interfere with study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REPEVAX followed by REVAXIS administration
Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diphtheria seroprotection rate
Time Frame: 28 to 35 days afeter each vaccine administration
28 to 35 days afeter each vaccine administration
Tetanus seroprotection rate
Time Frame: 28 to 35 days after each vaccine administration
28 to 35 days after each vaccine administration
Polio seroprotection rate
Time Frame: 28 to 35 days after each vaccine administration
28 to 35 days after each vaccine administration
Pertussis response rate
Time Frame: 28 to 35 days after REPEVAX administration
28 to 35 days after REPEVAX administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Solicited injection-site reactions, solicited systemic reactions
Time Frame: From day 0 to day 7 following REPEVAX and REVAXIS vaccination
From day 0 to day 7 following REPEVAX and REVAXIS vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time Frame: From day 0 to day 28 following REPEVAX and REVAXIS vaccination
From day 0 to day 28 following REPEVAX and REVAXIS vaccination
Number and proportion of Serious adverse events
Time Frame: From the first vaccination to the last visit of the subject
From the first vaccination to the last visit of the subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 2, 2011

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPV04C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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