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Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in Europeans Toddlers

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ClinicalTrials.gov Identifier: NCT03890367
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

Primary Objective:

To demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (geometric mean titers [GMT]). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT).If this superiority is demonstrated, then
  • the superiority of the seroprotection rate

Or to demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate or NeisVac-C® as measured by rSBA. If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT)

Secondary Objective:

To demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT).

Or to demonstrate:

  • the non-inferiority of the seroprotection rate (antibody titers ≥ 1:8) to meningococcal serogroup C following the administration of MenACYW conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority is demonstrated, then
  • the non-inferiority of the antibody response (GMT). If this non-inferiority is demonstrated, then
  • the superiority of the antibody response (GMT) .

Condition or disease Intervention/treatment Phase
Meningococcal Infection (Healthy Volunteers) Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine Biological: Meningococcal group A, C, W-135 and Y conjugate vaccine Biological: Meningococcal group C polysaccharide conjugate vaccine adsorbed Phase 3

Detailed Description:

Study duration per participant will be approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 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) and adverse event of special interest (AESI) throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 709 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Modified double-blind: the participant (or legally acceptable representative), and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety data collection.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age
Actual Study Start Date : September 12, 2019
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: MenACYW conjugate vaccine
MenACYW conjugate vaccine single injection at Day 0 (n=235)
Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Other Name: MenACYW conjugate vaccine

Active Comparator: Group 2: Nimenrix® vaccine
Nimenrix® vaccine single injection at Day 0 (n=235)
Biological: Meningococcal group A, C, W-135 and Y conjugate vaccine
Pharmaceutical form:Powder and solvent for suspension for injection Route of administration: Intramuscular
Other Name: Nimenrix®

Active Comparator: Group 3: NeisVac-C® vaccine
NeisVac-C® vaccine single injection at Day 0 (n=235)
Biological: Meningococcal group C polysaccharide conjugate vaccine adsorbed
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other Name: NeisVac-C®




Primary Outcome Measures :
  1. Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW conjugate vaccine or Nimenrix® (hSBA assessment) [ Time Frame: Day 30 ]
    Percentage of participants achieving seroprotection, defined as antibody titers equal or greater than (≥) 1:8 as measured by serum bactericidal assay using human complement (hSBA)

  2. Antibody titers against meningococcal serogroup C vaccination with MenACYW conjugate vaccine or Nimenrix® (hSBA assessment) [ Time Frame: Day 30 ]
    Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroup C as measured by hSBA

  3. Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW conjugate vaccine or NeisVac-C® [ Time Frame: Day 30 ]
    Percentage of participants achieving seroprotection, defined as antibody titers ≥ 1:8 as measured by serum bactericidal assay using baby rabbit complement (rSBA)

  4. Antibody titers against meningococcal serogroup C after vaccination with MenACYW conjugate vaccine or NeisVac-C® [ Time Frame: Day 30 ]
    GMTs of antibodies against meningococcal serogroup C as measured by rSBA


Secondary Outcome Measures :
  1. Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW<br>conjugate vaccine or Nimenrix® (rSBA assessment) [ Time Frame: Day 30 ]
    Percentage of participants achieving seroprotection, defined as antibody titer ≥ 1:8 as measured by rSBA

  2. Antibody titers against meningococcal serogroup C after vaccination with MenACYW conjugate vaccine or Nimenrix® (rSBA assessment) [ Time Frame: Day 30 ]
    GMTs of antibodies against meningococcal serogroup C as measured by rSBA

  3. Antibody titers against meningococcal serogroup C ≥ 1:8 after vaccination with MenACYW<br>conjugate vaccine or NeisVac-C® (hSBA assessment) [ Time Frame: Day 30 ]
    Percentage of participants achieving seroprotection, defined as antibody titer ≥ 1:8 as measured by hSBA

  4. Antibody titers against meningococcal serogroup C after vaccination with MenACYW conjugate vaccine or NeisVac-C® (hSBA assessment) [ Time Frame: Day 30 ]
    GMTs of antibodies against meningococcal serogroup C as measured by hSBA



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Aged 12 to 23 months on the day of the first study visit ("12 to 23 months" means from the 12th month after birth to the day before the 24th month after birth)
  • Informed consent form (ICF) has been signed and dated by the parent(s) / legally acceptable representative(s) and by an independent witness if required by local regulations
  • Subject and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion criteria:

  • Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study 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 vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • 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, W, or Y; or meningococcal B 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, 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 vaccines used in the study 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 (GBS).
  • Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected 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
  • 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 ≥ 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 72 hours prior to the first blood draw
  • Identified as a 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.


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): NCT03890367


Locations
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03890367    
Other Study ID Numbers: MEQ00065
2018-003790-10 ( EudraCT Number )
U1111-1217-2456 ( Other Identifier: UTN )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs