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Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT02842853
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of the study is to demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine and to demonstrate the immune non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine vs licensed MCV4 vaccine.

Primary Objectives:

  • To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers.
  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine.

Secondary Objective:

  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine in the adult population (18 to 55 years old)
  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine in the adolescent population (10 to 17 years old)

Observational Objectives:

  • To describe the safety profile of MenACYW conjugate vaccine and that of the licensed MCV4 vaccine.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Phase 3

Detailed Description:
Healthy meningococcal-vaccine naïve adolescents and adults will be enrolled, randomized and will receive a single dose of either MenACYW conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3) or licensed MCV4 vaccine. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 1 month post-vaccination. Safety information will be collected post-vaccination and through the entire study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MenACYW conjugate vaccine Lot 1
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 1
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular (Lot 1)
Other Name: MenACYW conjugate vaccine

Experimental: MenACYW conjugate vaccine Lot 2
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 2
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular (Lot 2)
Other Name: MenACYW conjugate vaccine

Experimental: MenACYW conjugate vaccine Lot 3
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 3
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular (Lot 3)
Other Name: MenACYW conjugate vaccine

Active Comparator: Licensed MCV4 vaccine
Participants randomized to receive a dose of licensed MCV4 vaccine
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Licensed MCV4 vaccine




Primary Outcome Measures :
  1. Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA post-vaccination between lots for immune lot consistency [ Time Frame: Day 30 post-vaccination ]
  2. Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W following vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine [ Time Frame: Day 30 post-vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement


Secondary Outcome Measures :
  1. Number of adolescent participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine [ Time Frame: Day 30 post-vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement

  2. Number of adults participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine [ Time Frame: Day 30 post-vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement

  3. Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or Licensed MCV4 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, including serious adverse events throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 10 to 55 years on the day of inclusion
  • Informed consent form has been signed and dated by the subject (aged 18 to 55 years) or assent form has been signed and dated by the subject and informed consent form has been signed and dated by the parent(s) or guardian (for subjects aged 10 to < 18 years)
  • Subject (≥ 18 years) or subject (10 to < 18 years) and parent / guardian are 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 pre-menarche or 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 the study investigational vaccines. 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 traveling to countries with high endemic or epidemic disease)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / guardian, 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
  • Personal history of Guillain-Barre syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study 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]). 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842853


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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02842853     History of Changes
Other Study ID Numbers: MET43
U1111-1161-3060 ( Other Identifier: WHO )
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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".

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW conjugate vaccine
Licensed MCV4 vaccine

Additional relevant MeSH terms:
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Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs