Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.

The secondary objectives of the study are:

• To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
• To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
• To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
• To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers (Meningococcal Infection)
• Intervention / Treatment: Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Biological: Haemophilus b Conjugate Vaccine; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Varicella Virus Vaccine Live; Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine

Detailed Description

Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

• Study Type: Interventional
• Enrollment (Actual): 950
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Guayama, Puerto Rico, 007874
    • Investigational Site Number : 6300102
  • San Juan, Puerto Rico, 00918
    • Investigational Site Number : 6300014
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics Site Number : 8400036
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates Site Number : 8400009
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • MedPharmics, LLC - Phoenix Site Number : 8400013
  • California
    • Anaheim, California, United States, 92804
      • Emmaus Research Center, Inc Site Number : 8400019
    • Bellflower, California, United States, 90706
      • Coast Clinical Trials, LLC Site Number : 8400073
    • Gardena, California, United States, 90247
      • Matrix Clinical Research Site Number : 8400082
    • Madera, California, United States, 93637
      • Madera Family Med Group Site Number : 8400065
  • Florida
    • Homestead, Florida, United States, 33030
      • Next Phase Research Alliance Site Number : 8400044
    • Land O' Lakes, Florida, United States, 34639
      • PAS Research Site Number : 8400101
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research Site Number : 8400021
    • Miami, Florida, United States, 33144
      • Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
    • Miami, Florida, United States, 33186
      • Biomedical Research LLC Site Number : 8400041
    • Miami Lakes, Florida, United States, 33014
      • Crystal Biomedical Research Site Number : 8400034
    • Tampa, Florida, United States, 33613
      • PAS Research Site Number : 8400059
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Omega Pediatrics Site Number : 8400093
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research, PLLC Site Number : 8400058
  • Illinois
    • Chicago, Illinois, United States, 60621
      • Eagle Clinical Research Site Number : 8400094
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Brownsboro Park Pediatrics Site Number : 8400039
    • Louisville, Kentucky, United States, 40243
      • All Children Pediatrics Site Number : 8400024
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research, LLC Site Number : 8400035
    • Metairie, Louisiana, United States, 70006
      • Velocity Clinical Research Site Number : 8400016
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton Physician Network Site Number : 8400075
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Victory Clinical Research Site Number : 8400026
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • Pediatric Associates of Fall River Site Number : 8400112
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Craig Spiegel, MD Site Number : 8400023
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research Site Number : 8400097
    • Lincoln, Nebraska, United States, 68504
      • Midwest Childrens Health Research Institute Site Number : 8400111
    • Lincoln, Nebraska, United States, 68505
      • Midwest Childrens Health Research Institute Site Number : 8400117
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • MedPharmics Inc Site Number : 8400006
  • New York
    • New York, New York, United States, 10468
      • Advantage Clinical Trials Site Number : 8400069
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Health Site Number : 8400054
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Site Number : 8400022
    • Dayton, Ohio, United States, 45419
      • PriMed Clinical Research Site Number : 8400008
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University - Center for Health Sciences Site Number : 8400110
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research Site Number : 8400010
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • Allegheny Health and Wellness Pavilion Site Number : 8400025
    • Hermitage, Pennsylvania, United States, 16148
      • Kid's Way Pediatrics Site Number : 8400015
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research Charleston Site Number : 8400002
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research Charleston Site Number : 8400011
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research Site Number : 8400118
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • Pediatric Clinical Trials Tullahoma Site Number : 8400106
  • Texas
    • Beaumont, Texas, United States, 77706
      • Tekton Research Site Number : 8400047
    • Dickinson, Texas, United States, 77539
      • Mercury Clinical Research, Inc. Site Number : 8400088
    • Houston, Texas, United States, 77074-2085
      • Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
    • San Antonio, Texas, United States, 78240
      • Tekton Research, Inc. Site Number : 8400040

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria :

• Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
• Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
• Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
• For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
• For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

Exclusion criteria:

• Participation at the time of study enrollment or in the 4 weeks preceding the first 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 preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. 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 serogroup-containing vaccine)
• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
• 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
• Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
• Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
• Individuals with active tuberculosis
• History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
• 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)
• History of intussusception
• History of any neurologic disorders, including any seizures and progressive neurologic disorders
• History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
• History of Guillain-Barré syndrome
• Known systemic hypersensitivity to any of the vaccine components or to latex, 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, including neomycin, gelatin, and yeast
• 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
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age	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, 0.5 mL; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Haemophilus b Conjugate Vaccine; Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL; Biological: Pneumococcal 13-valent Conjugate Vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL; Biological: Hepatitis B Vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Active Comparator: Group 2; MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age	Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Haemophilus b Conjugate Vaccine; Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL; Biological: Pneumococcal 13-valent Conjugate Vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL; Biological: Hepatitis B Vaccine; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL; Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Experimental: Group 3; MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age	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, 0.5 mL
Active Comparator: Group 4; Menactra® at 17 to 19 months of age and 20 to 23 months of age	Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine; Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8.	Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers >= 1:8.	At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed.	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed.	PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed.	At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed.	Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.	Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed.	Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed.	At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed.	At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MET61 (Other Identifier: Sanofi Identifier); U1111-1205-2836 (Registry Identifier: ICTRP); 2019-004460-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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://vivli.org

Drug and device information, study documents

• 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.: No