Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

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

An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

Primary objectives:

To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

Secondary objectives:

•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

•Secondary safety objective: To describe the safety profile after vaccination in each group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

954

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
      • Angers, France
        • Sanofi Pasteur MSD Investigational Site
      • Châtellerault, France
        • Sanofi Pasteur MSD Investigational Site
      • Clermont-Ferrand, France
        • Sanofi Pasteur MSD Investigational Site
      • Gieres, France
        • Sanofi Pasteur MSD Investigational Site
      • Grenoble, France
        • Sanofi Pasteur MSD Investigational Site
      • Hérouville Saint-Clair, France
        • Sanofi Pasteur MSD Investigational Site
      • La Rochelle, France
        • Sanofi Pasteur MSD Investigational Site
      • Lyon, France
        • Sanofi Pasteur MSD Investigational Site
      • Poitiers, France
        • Sanofi Pasteur MSD Investigational Site
      • Strasbourg, France
        • Sanofi Pasteur MSD Investigational Site
      • Tierce, France
        • Sanofi Pasteur MSD Investigational Site
      • Tours, France
        • Sanofi Pasteur MSD Investigational Site
  • Germany
      • Berlin, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Dresden, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Essen, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Hamburg, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Heilbronn, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Künzing, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Potsdam, Germany
        • Sanofi Pasteur MSD Investigational Site
      • Reichenbach, 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

60 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged ≥60 years
  • At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
  • No influenza vaccine administered during the last 6 months

Exclusion Criteria:

  • Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
  • Receipt of pertussis-containing vaccine or 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
  • 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 unstable neurological disorders
  • Known or suspected immune dysfunction
  • Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
  • Chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- VAXIGRIP and REPEVAX concomitantly
Biological: Concomitant administration
1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
Active Comparator: 2-REPEVAX 28 days after VAXIGRIP
Biological: Separate administration
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diphtheria seroprotection rate
Time Frame: 28 to 35 days after vaccine administration
28 to 35 days after vaccine administration
Tetanus seroprotection rate
Time Frame: 28 to 35 days after vaccine administration
28 to 35 days after vaccine administration
Polio seroprotection rate
Time Frame: 28 to 35 days after vaccine administration
28 to 35 days after vaccine administration
Pertussis antibody titre
Time Frame: 28 to 35 days after vaccine administration
28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
Time Frame: 28 to 35 days after vaccine administration
28 to 35 days after vaccine administration

Secondary Outcome Measures

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

October 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 29, 2010

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

  • RPV03C

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.

Clinical Trials on Pertussis

Clinical Trials on Concomitant administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe