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Trial record 4 of 22 for:    MET | Meningococcal Disease | Sanofi Pasteur [Lead]

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (MET33)

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ClinicalTrials.gov Identifier: NCT03630705
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE October 17, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Before the first vaccination and 30 days after the last vaccination in second year of life (Dose 3 of MenACYW conjugate vaccine and Dose 4 of Menveo®) ]
  1. Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA, assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine or Menveo® in Mexico (Group 1 versus [vs] Group 2)
  2. Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine in the Russian Federation (Group 3)
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Day 0 (pre-vaccination ) and Day 30 after the last vaccination in second year of life (Dose 3 of MenACYW conjugate vaccine and Dose 4 of Menveo®) ]
Titers are measured by serum bactericidal assay using human complement (hSBA), and expressed as geometric mean titers (GMTs)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Antibody titers against meningococcal serogroups A, C, Y, and W after infant series vaccination [ Time Frame: Before the first vaccination and 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) ]
    1. Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the infant series with MenACYW conjugate vaccine or Menveo® (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) in Mexico (Group 1 vs Group 2)
    2. Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the infant series with MenACYW conjugate
  • Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after any injection ]
    Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Antibody titers against meningococcal serogroups A, C, Y, and W after infant series vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 30 after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) ]
    Titers are expressed as GMTs
  • Number of participants with Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after any injection ]
    Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Official Title  ICMJE Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Brief Summary

Primary Objective:

  1. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
  2. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation

Secondary Objective:

  1. To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Groups 1 and 2, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
  2. To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Group 3, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation
Detailed Description Study duration per participant is approximately 12 months
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers (Meningococcal Infection)
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Pharmaceutical form: Liquid solution Route of administration : Intramuscular
  • Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
    Other Name: Menveo®
  • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
  • Biological: Pneumococcal 13-valent Conjugate Vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
  • Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
    Pharmaceutical form: Powder and suspension for injection Route of administration: Subcutaneous
  • Biological: Hepatitis B Vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
  • Biological: Rotavirus Vaccine, Live, Pentavalent
    Pharmaceutical form: Oral solution Route of administration: Oral
  • Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
    Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Study Arms  ICMJE
  • Experimental: Group 1 (Mexico)
    MenACYW conjugate vaccine at 2, 6, and 12 months of age + routine pediatric vaccines at 2, 4, 6, and 12 months of age
    Interventions:
    • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Rotavirus Vaccine, Live, Pentavalent
    • Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
  • Active Comparator: Group 2 (Mexico)
    Menveo® at 2, 4, 6, and 12 months of age + routine pediatric vaccines at 2, 4, 6, and 12 months of age
    Interventions:
    • Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Rotavirus Vaccine, Live, Pentavalent
    • Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
  • Experimental: Group 3 (Russian Federation)
    MenACYW conjugate vaccine at 3, 6, and 12 months of age + routine pediatric vaccines at 2, 3, 4.5, 6, and 12 months of age
    Interventions:
    • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
    • Biological: Hepatitis B Vaccine
  • Group 4 (Russian Federation)
    Routine pediatric vaccines at 2, 3, 4, 5, 6, and 12 months of age
    Interventions:
    • Biological: Measles, Mumps, and Rubella Virus Vaccine Live
    • Biological: Pneumococcal 13-valent Conjugate Vaccine
    • Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
    • Biological: Hepatitis B Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
525
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
825
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

  • Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.*
  • Born after a full-term pregnancy, with an estimated gestation age ≥ 37 weeks and a birth weight ≥ 2.5 kg.
  • Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
  • In good health as determined by medical history and physical assessment.
  • For the Russian Federation: The subject's parents are able to verbally report or provide written documentation that the subject's mother was hepatitis B antigennegative during pregnancy with the subject.

    • "2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days).

      • In the Russian Federation, as per local regulations, only the subject's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian will not be included in the study

Exclusion criteria:

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:

  • 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 a gap of 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 (ie, meningitis polysaccharide or meningitis conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella.
  • For Mexico: More than 1 previous dose of hepatitis B vaccine.
  • Receipt of immune globulins, blood or blood-derived products since birth.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
  • 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, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / 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 traveling to countries with high endemic or epidemic disease)
  • History of intussusception.
  • History of any neurologic disorders, including seizures (febrile and non-febrile) and progressive neurologic disorders.
  • 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 vaccines 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 of 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*). 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.

    • For the Russian Federation, febrile illness is defined as temperature ≥ 37 C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # RegistryContactUS@sanofipasteur.com
Listed Location Countries  ICMJE Mexico,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630705
Other Study ID Numbers  ICMJE MET33
U1111-1183-6409 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP