Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine,in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)

Overview

Primary Objective:

To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW conjugate vaccine or Menveo vaccine 3-6 years before the booster dose (Groups 1 and 2)

Secondary Objectives:

To describe:

- the vaccine seroresponse, seroprotection (serum bactericidal assay using human complement [hSBA] titer ≥1:8), and antibody responses (geometric mean titers [GMTs]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 subjects per group (Groups 1 and 2)

- the vaccine seroresponse, seroprotection (hSBA titer ≥1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on D0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW conjugate vaccine alone (Groups 1 and 2)

- the antibody persistence (GMTs and vaccine seroprotection; hSBA titer ≥1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in subjects who received either MenACYW conjugate vaccine or Menveo vaccine 3-6 years earlier

- the antibody persistence (GMTs and vaccine seroprotection; hSBA titer ≥1:8) of meningococcal serogroups A, C, Y, and W in subjects who received either a single dose MenACYW conjugate vaccine (subjects randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (subjects assigned to MET59 Group 2), as part of study MET50, or MET43 (subjects randomized to MET59 Groups 1, 3 and 4)

- the vaccine seroresponse, seroprotection (hSBA titer ≥1:8), and antibody responses (GMTs) to the antigens present in MenACYW conjugate vaccine, when MenACYW conjugate vaccine is given concomitantly with MenB vaccine (Groups 3 and 4), compared to those when it is given alone (Group 1)

Full Title of Study: “Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

Detailed Description

Study duration per participant will be approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.

Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.

Interventions

  • Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
    • Pharmaceutical form: Solution for injection Route of administration: Intramuscular
  • Biological: Meningococcal Group B Vaccine (Trumenba®)
    • Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular
  • Biological: Meningococcal group B Vaccine (Bexsero®)
    • Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Arms, Groups and Cohorts

  • Experimental: Group 1: MenACYW conjugate vaccine
    • MenACYW conjugate vaccine single injection at Day 0 in participants who received a prior dose of MenACYW conjugate vaccine 3-6 years earlier
  • Experimental: Group 2: MenACYW conjugate vaccine
    • MenACYW conjugate vaccine single injection at Day 0 in participants who received a prior dose of Menveo® 3-6 years earlier
  • Experimental: Group 3: MenACYW conjugate vaccine + Trumenba®
    • MenACYW conjugate vaccine single injection + Trumenba single injection at Day 0 in participants who received a prior dose of MenACYW conjugate vaccine 3-6 years earlier
  • Experimental: Group 4: MenACYW conjugate vaccine + Bexsero®
    • MenACYW conjugate vaccine single injection + Bexsero single injection at Day 0 n participants who received a prior dose of MenACYW conjugate vaccine 3-6 years earlier

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2
    • Time Frame: Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers equal or greater than (≥) 1:16 for participants with pre-vaccination titers lower than (<) 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8

Secondary Measures

  • Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2
    • Time Frame: Day 6 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
  • Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2
    • Time Frame: Day 6 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
  • Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2
    • Time Frame: Day 6 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
  • Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
  • Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
  • GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
  • Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W
    • Time Frame: Day 0 (pre-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
  • GMTs of antibodies against meningococcal serogroups A, C, Y, and W
    • Time Frame: Day 0 (pre-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
  • Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
  • GMTs of antibodies against meningococcal serogroups A, C, Y, and W
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
  • Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
  • Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
  • GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1, Group 3 and Group 4
    • Time Frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
    • Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA

Participating in This Clinical Trial

Inclusion criteria :

  • Aged ≥ 13 to < 26 years on the day of inclusion
  • Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only)
  • For Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants have a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion
  • Participants aged 13 to < 18 years: assent form has been signed and dated by the participant and informed consent form (ICF) has been signed and dated by the parent or guardian
  • Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: ICF has been signed and dated by the participants
  • Participant aged 13 to < 18 years: both the participant and parent or guardian are able to attend all scheduled visits and to comply with all trial procedures
  • Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
  • 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 Visit 3 except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccine
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43
  • Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine
  • 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 participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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 vaccines used in the trial or to a vaccine containing any of the same substances
  • Personal history of Guillain-Barré syndrome (GBS)
  • 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
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Current alcohol abuse or drug addiction
  • Chronic illness (eg, HIV, hepatitis B, hepatitis C) 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 participant 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 26 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sanofi Pasteur, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi Pasteur, a Sanofi Company
  • Overall Contact(s)
    • Trial Transparency email recommended (Toll free number for US & Canada), 800-633-1610, Contact-US@sanofi.com

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