Skip to main content
OpenTrials
Completed

NCT Number: NCT01287949

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pertussis Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi Pasteur MSD investigational site, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diphtheria, tetanus, polio and pertussis vaccination

Biological

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

Primary outcomes

  1. Diphtheria seroprotection rate

    Time frame: 28 to 35 days afeter each vaccine administration

  2. Tetanus seroprotection rate

    Time frame: 28 to 35 days after each vaccine administration

  3. Polio seroprotection rate

    Time frame: 28 to 35 days after each vaccine administration

  4. Pertussis response rate

    Time frame: 28 to 35 days after REPEVAX administration

Secondary outcomes

  1. Solicited injection-site reactions, solicited systemic reactions

    Time frame: From day 0 to day 7 following REPEVAX and REVAXIS vaccination

  2. Unsolicited injection-site adverse reactions and systemic adverse events

    Time frame: From day 0 to day 28 following REPEVAX and REVAXIS vaccination

  3. Number and proportion of Serious adverse events

    Time frame: From the first vaccination to the last visit of the subject

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2011
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.