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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01287949
First received: January 31, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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

Condition Intervention Phase
Diphtheria
Tetanus
Poliomyelitis
Pertussis
Biological: Diphtheria, tetanus, polio and pertussis vaccination
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Diphtheria seroprotection rate [ Time Frame: 28 to 35 days afeter each vaccine administration ] [ Designated as safety issue: No ]
  • Tetanus seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ] [ Designated as safety issue: No ]
  • Polio seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ] [ Designated as safety issue: No ]
  • Pertussis response rate [ Time Frame: 28 to 35 days after REPEVAX administration ] [ Designated as safety issue: No ]

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

Enrollment: 342
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287949

Locations
France
Sanofi Pasteur MSD investigational site
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
Germany
Sanofi Pasteur MSD investigational site
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
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: NCT01287949     History of Changes
Other Study ID Numbers: RPV04C
Study First Received: January 31, 2011
Last Updated: June 6, 2012
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
Poliomyelitis
Pertussis (acellular)
Biological/vaccine

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

ClinicalTrials.gov processed this record on July 23, 2014