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Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT02752906
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to describe the safety and antibody response to revaccination with MenACYW conjugate vaccine in persons who received their first quadrivalent meningococcal conjugate vaccine dose at ≥ 10 years of age.

Primary Objective:

  • To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine compared to those observed following the administration of a booster dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose.

Secondary Objectives:

  • To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of subjects
  • To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination

Observational Objectives:

  • To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination
  • To describe the safety profile of MenACYW conjugate vaccine compared to that of a licensed MCV4 after booster vaccination.

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 adolescents and adults who had received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years previously will be randomized to receive either 1 dose of MenACYW conjugate vaccine or a licensed MCV4 . All participants will undergo immunogenicity assessment at baseline (pre-vaccination) and 1 month post-vaccination and will also be evaluated for safety up to Day 180 post-vaccination. In addition, a subset will have an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Percentage of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4 [ Time Frame: Day 0 (pre vaccination) and Day 30 post vaccination ]
    Seroresponse is based on antibody titers against meningococcal serogroups A, C, Y, and W that will be assessed by human serum bactericidal assay


Secondary Outcome Measures :
  1. Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4 [ Time Frame: Day 6 post vaccination ]
    Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement

  2. 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 a licensed MCV4 [ Time Frame: Day 0 (pre vaccination) and Day 30 post vaccination ]
    The antibody titers against Meningococcal serogroups A, C, Y, and W will be assessed by hSBA

  3. Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or a licensed MCV4 [ 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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 15 years on the day of inclusion
  • Subject has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to enrollment
  • Subject aged 15 to < 18 years: assent form signed and dated by the subject and informed consent form (ICF) signed and dated by the parent or guardian
  • Subject aged ≥ 18 years: ICF signed and dated by the subject
  • Subjects aged 15 to < 18 years: both the subject and parent / guardian are able to attend all scheduled visits and to comply with all trial procedures
  • Subjects aged ≥ 18 years: able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Subject is pregnant, 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 before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Previous vaccination against meningococcal disease with either an investigational or approved 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 any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
  • Personal history of Guillain-Barré syndrome
  • 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 the Investigator's 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): NCT02752906


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
Dothan, Alabama, United States, 36305
United States, Arizona
Mesa, Arizona, United States, 85213
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
La Puente, California, United States, 91744
San Diego, California, United States, 92108
United States, Iowa
Council Bluffs, Iowa, United States, 51503
United States, Kentucky
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Missouri
Bridgeton, Missouri, United States, 63044
United States, Nebraska
Lincoln, Nebraska, United States, 68504
United States, Ohio
Cincinnati, Ohio, United States, 45245
Dayton, Ohio, United States, 45414
Dayton, Ohio, United States, 45419
United States, Tennessee
Tullahoma, Tennessee, United States, 37388
United States, Utah
Salt Lake City, Utah, United States, 84109
South Jordan, Utah, United States, 84095
Puerto Rico
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02752906     History of Changes
Other Study ID Numbers: MET56
U1111-1161-2710 ( Other Identifier: WHO )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 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 clinicalstudydatarequest.com. While making information available at Sanofi continues 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
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW conjugate vaccine
Licensed Meningococcal Conjugate Vaccine (MCV4)
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningococcal Infections
Meningitis
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