Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01249183
First received: November 17, 2010
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Poliomyelitis
 Biological: Concomitant administration
Biological: Separate administration
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Diphtheria seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ] [ Designated as safety issue: No ]
  • Tetanus seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ] [ Designated as safety issue: No ]
  • Polio seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ] [ Designated as safety issue: No ]
  • Pertussis antibody titre [ Time Frame: 28 to 35 days after vaccine administration ] [ Designated as safety issue: No ]
  • Flu geometric mean of titres ratio [ Time Frame: 28 to 35 days after vaccine administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited injection-site reactions, solicited systemic adverse reactions [ Time Frame: From Day 0 to Day 7 following REPEVAX vaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination ] [ Designated as safety issue: Yes ]
  • Number and proportion of Serious adverse events [ Time Frame: From the first visit to the last visit of the subject ] [ Designated as safety issue: Yes ]

Enrollment: 954
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249183

Locations
France
Sanofi Pasteur MSD Investigational Site
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
Germany
Sanofi Pasteur MSD Investigational Site
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
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Marie WEHRLEN-GRANDJEAN, MD Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01249183     History of Changes
Other Study ID Numbers: RPV03C
Study First Received: November 17, 2010
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi Pasteur MSD:
Diphtheria
Tetanus
Pertussis (acellular, component)
Diphteria
Biological / vaccine

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 22, 2013