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

November 17, 2010
October 10, 2011
October 2010
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01249183 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
  • 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)
  • Biological: Separate administration
    1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
  • Experimental: 1- VAXIGRIP and REPEVAX concomitantly
    Intervention: Biological: Concomitant administration
  • Active Comparator: 2-REPEVAX 28 days after VAXIGRIP
    Intervention: Biological: Separate administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
954
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT01249183
RPV03C
No
Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Study Director: Marie WEHRLEN-GRANDJEAN, MD Sanofi Pasteur MSD
Sanofi Pasteur MSD
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP