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OpenTrials
Completed

NCT Number: NCT01249183

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

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

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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

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi Pasteur MSD Investigational Site, Angers, France

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Concomitant administration

Biological

1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)

Separate administration

Biological

1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

Primary outcomes

  1. Diphtheria seroprotection rate

    Time frame: 28 to 35 days after vaccine administration

  2. Tetanus seroprotection rate

    Time frame: 28 to 35 days after vaccine administration

  3. Polio seroprotection rate

    Time frame: 28 to 35 days after vaccine administration

  4. Pertussis antibody titre

    Time frame: 28 to 35 days after vaccine administration

  5. Flu geometric mean of titres ratio

    Time frame: 28 to 35 days after vaccine administration

Secondary outcomes

  1. Solicited injection-site reactions, solicited systemic adverse reactions

    Time frame: From Day 0 to Day 7 following REPEVAX vaccination

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

    Time frame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination

  3. Number and proportion of Serious adverse events

    Time frame: From the first visit 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, 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2010
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.

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