Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Intervention: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine); Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®); Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine; Pneumococcal 13-valent Conjugate Vaccine; Rotavirus Vaccine; Hepatitis B Vaccine; Measles, Mumps, and Rubella Virus Vaccine; Varicella Virus Vaccine
Intervention description: Pharmaceutical form: Liquid solution. Route of administration: Intramuscular; Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular; Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB 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; Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous; Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A modified double blind design was used. With the exception of the personnel administering the vaccine, everyone involved in study (participants, care provider, investigator, safety outcomes assessor, Sponsor) was blinded.
Enrollment: 2797.0
Sex: All
Minimum age: 42 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study was to describe the safety profile of Meningococcal
      Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and
      Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®)
      Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy
      infants and toddlers.
    

Eligibility criteria:

        Inclusion criteria:

          -  Aged >= 42 to <= 89 days on the day of the first study visit.

          -  Healthy infants as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Informed consent form was signed and dated by the parent(s) or guardian (and by an
             independent witness if required by local regulations).

          -  Participant and parent/guardian were able to attend all scheduled visits and complied
             with all trial procedures.

          -  Infants who received the first dose of hepatitis B vaccine at least 28 days before the
             first study visit.

        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 might 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).

          -  Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis
             A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b,
             Streptococcus pneumoniae, and /or rotavirus infection or disease.

          -  Receipt of 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 was 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, 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 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 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.

          -  Chronic illness (including, but not limited to, cardiac disorders, congenital heart
             disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes,
             psychomotor diseases, and known congenital or genetic diseases) 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 degree Celsius [>=
             100.4-degree Fahrenheit]). A prospective participant 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 was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.