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)

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    525
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 23 January 2022
Accepts healthy volunteers

Summary

Primary Objective:

  1. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and
  2. 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
  3. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and
  4. 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

Description

Study duration per participant is approximately 12 months

Details
Condition Healthy Volunteers (Meningococcal Infection)
Treatment Hepatitis B vaccine, Pneumococcal 13-valent Conjugate Vaccine, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine, Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine, Rotavirus Vaccine, Live, Pentavalent
Clinical Study IdentifierNCT03630705
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on23 January 2022

Eligibility

Yes No Not Sure

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
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