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
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Intervention: 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; Pneumococcal 13-valent Conjugate Vaccine; Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine; Hepatitis B Vaccine; Rotavirus Vaccine, Live, Pentavalent; Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Intervention description: Pharmaceutical form: Liquid solution Route of administration : Intramuscular; Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular; Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Oral solution Route of administration: Oral; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: All
Minimum age: 2 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

        1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=]
           1:8) 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 vaccine seroprotection (antibody titer >=1:8) 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 hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y,
           and W) 30 days after the last vaccination of the infant series, when administered
           concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
           and Russian Federation (RF).

        2. To describe immunogenicity profile of routine pediatric vaccines when administered
           concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.

        3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when
           MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine
           pediatric vaccines in Mexico and RF.

        4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and
           Menveo®, before the first vaccination and 30 days after the last vaccination of the
           infant series and in the second year of life, when administered concomitantly with
           routine pediatric vaccines in a subset of participants in Mexico and RF.
    

Eligibility criteria:

        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 kilograms.

          -  Informed consent form has been signed and dated by the parent(s) or guardian(s), as
             required by local regulations.†

          -  Participant and parent/guardian were 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 participant's parents were able to verbally report or
             provide written documentation that the participant's mother was hepatitis B antigen
             negative during pregnancy with the participant.

               -  * "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
                       participant's parent(s) were entitled to sign an informed consent form. A
                       child under the responsibility of a guardian would not be included in the
                       study.

        Exclusion criteria:

        An individual fulfilling any of the following criteria was 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 (i.e., 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, participants with persistent complement deficiency, with anatomic or
             functional asplenia, or participants 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 degree Celsius [°C]). A
             prospective participant should not be included in the study until the condition had
             resolved or the febrile event had 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 was defined as temperature >= 37°C. A
                  prospective participant should not be included in the study until the condition
                  had resolved or the febrile event had subsided.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.