Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM + MMRV; MMRV; MenACWY-CRM
Intervention description: One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.; one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age; Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1630.0
Sex: All
Minimum age: 7 Months
Maximum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; toddlers; healthy; meningitis; meningococcal; measles; mumps; rubella; varicella; Prevention of Meningococcal disease types ACWY

Summary:

      Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy
      toddlers
    

Eligibility criteria:

        Inclusion Criteria:

          -  who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for
             whom, after the nature of the study has been explained, the parent or legal guardian
             has provided written informed consent;

          -  who have received complete primary vaccination with recommended licensed vaccines;

          -  who are available for all visits and telephone calls scheduled for the study;

        Exclusion Criteria:

          -  whose parent or legal guardian is unwilling or unable to give written informed assent
             consent

          -  who had a previous or suspected disease caused by N. meningitidis;

          -  who had previous or suspected infection with measles, mumps, rubella, varicella,
             and/or herpes zoster;

          -  who had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis infection within 60 days prior to enrollment;

          -  who had household contact with and/or intimate exposure to an individual with measles,
             mumps, rubella and/or varicella infection within 60 days prior to enrollment;

          -  who have previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s)

          -  who have previously received any measles, mumps, rubella or varicella vaccine either
             alone or in any combination;

          -  who have received any investigational agents or vaccines within 90 days prior to
             enrollment or who expect to receive an investigational agent or vaccine prior to the
             completion of the study;

          -  who have any serious acute, chronic or progressive disease such as, cancer, diabetes,
             heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome

          -  who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of
             the vaccine,

          -  who have a known or suspected impairment/alteration of immune function, either
             congenital or acquired

          -  who have Down's syndrome or other known cytogenic disorders; bleeding diathesis