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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

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ClinicalTrials.gov Identifier: NCT02842866
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date February 9, 2018
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Percentage of participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Menomune® [ Time Frame: Day 30 post-vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
  • Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA after vaccination with MenACYW conjugate vaccine or Menomune® [ Time Frame: Day 30 post-vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02842866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
Number of participants reporting solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or Menomune vaccine [ Time Frame: Day 0 up to Day 180 post-vaccination ]
Solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), medically attended adverse events collected from visit 2 to the 6 months follow up, and serious adverse events following vaccination with MenACYW conjugate vaccine or Menomune vaccine throughout the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
Official Title  ICMJE Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older
Brief Summary

The aim of the study is to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of MenACYW conjugate vaccine compared to a single dose of Menomune® - A/C/Y/W-135 in adults 56 years of age and older in the US.

Primary objective:

  • To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to those observed following the administration of a single dose of Menomune® - A/C/Y/W-135.

Secondary objective:

  • To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135

Observational objectives:

  • To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135.
  • To describe the safety profile of MenACYW conjugated vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.
Detailed Description

Subjects will be randomized in a 1:1 ratio to receive a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 on Day 0 (Visit 1).

They will undergo immunogenicity assessment at baseline (pre-vaccination) and at 30 to 44 days post-vaccination and will also be evaluated for safety up to Day 180 post-vaccination.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    0.5 mL, Intramuscular
    Other Name: MenACYW conjugate vaccine
  • Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined
    0.5 mL, Intramuscular
    Other Name: Menomune® A/C/Y/W 135
Study Arms  ICMJE
  • Experimental: MenACYW Conjugate Vaccine Group
    Participants randomized to receive a dose of MenACYW conjugate vaccine
    Intervention: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
  • Active Comparator: Menomune® A/C/Y/W135 Vaccine Group
    Participants randomized to receive a dose of Menomune® A/C/Y/W135 Vaccine
    Intervention: Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2018)
910
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
900
Actual Study Completion Date  ICMJE February 8, 2017
Actual Primary Completion Date February 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 56 years 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 until at least 4 weeks after vaccination)
  • Participation 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 (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B 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 (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
  • Known systemic hypersensitivity to latex or any of the vaccine components, or history of a life-threatening reaction to the vaccine 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
  • Verbal report of thrombocytopenia, contraindicating intramuscular vaccination, in the Investigator's opinion
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
  • 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). 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 72 hours prior to the first blood draw
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 56 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842866
Other Study ID Numbers  ICMJE MET49
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available the company continue to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date February 2018

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