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Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01732627
First received: November 13, 2012
Last updated: November 11, 2013
Last verified: November 2013

November 13, 2012
November 11, 2013
November 2012
June 2013   (final data collection date for primary outcome measure)
  • Percentages of Participants with Seroresponse in terms of functional antibodies to the meningococcal serogroups after Vaccination with either MenACYW conjugate or Menomune® Vaccine [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity endpoints on serum bactericidal antibody titers for each meningococcal serogroup will be measured by serum bactericidal assay using human and rabbit complements
  • Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring after vaccination with either MenACYW conjugate or Menomune® Vaccine [ Time Frame: Day 0 up to Day 30 post vaccination. ] [ Designated as safety issue: No ]
    Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.
Same as current
Complete list of historical versions of study NCT01732627 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

Primary objectives:

  • To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135.
  • To describe the safety profile of a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135.

All participants will receive a single dose of their assigned vaccine on Day 0. They will be assessed for immunogenicity on Day 30, and monitored for safety throughout the study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
  • Invasive Meningococcal Disease
  • Biological: MenACYW Conjugate Vaccine
    0.5 mL, Intramuscular
  • Biological: Meningococcal Polysaccharide Vaccine Groups A, C, Y, W 135 Combined
    0.5 mL, Subcutaneous
    Other Name: Menomune® A/C/Y/W 135
  • Experimental: MenACYW Vaccine Group
    Participants who receive MenACYW conjugate vaccine
    Intervention: Biological: MenACYW Conjugate Vaccine
  • Active Comparator: Menomune® A/C/Y/W 135 Vaccine Group
    Participants will receive Menomune® A/C/Y/W 135 Vaccine
    Intervention: Biological: Meningococcal Polysaccharide Vaccine Groups A, C, Y, W 135 Combined
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
September 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 56 or older on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
  • Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
  • Previous vaccination against meningococcal disease with either a trial vaccine or another vaccine
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
  • At high risk for meningococcal infection during the trial
  • Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood draw. Should a subject receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the Investigator will postpone the blood draw until it has been 3 days since the subject last received oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw indicated in the Table of Study Procedures, when possible
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Both
56 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01732627
MET44, U1111-1127-6804
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
November 2013

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