Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal ACWY-CRM conjugate vaccine; Meningococcal ACWY-PS polysaccharide vaccine
Intervention description: MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.; MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1500.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; children; vaccine; safety; efficacy

Summary:

      Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in
      children 2 to 10 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave
             written informed consent at the time of enrollment;

          -  Available for all visits and telephone calls (parents or legal guardians) scheduled
             for the study;

          -  Good health as determined by the clinical judgment of the investigator.

        Exclusion Criteria:

        Individuals not eligible to be enrolled into the study were those:

          -  whose parent or legal guardian was unwilling or unable to give written informed
             consent to participate in the study;

          -  whose parent or legal guardian were perceived as unreliable or unavailable for the
             duration of the study period;

          -  who had a previous or suspected disease caused by N meningitidis;

          -  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 previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s) (licensed or investigational);

          -  who had received any investigational agents or vaccines within 90 days prior to
             enrollment or who expected to receive an investigational agent or vaccine prior to the
             completion of the study;

          -  who had received any licensed vaccines within one month prior to enrollment or for
             whom receipt of a licensed vaccine was anticipated within one month after vaccination
             (Exception: influenza vaccine could be administered up to 15 days prior to study
             vaccination and no less than 15 days after study vaccination);

          -  who had received a live viral vaccine within 60 days prior to enrollment;

          -  who had experienced, within the 7 days prior to enrollment, significant acute or
             chronic infection (for example requiring systemic antibiotic treatment or antiviral
             therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3
             days prior to enrollment;

          -  who had any serious acute, chronic or progressive disease (e.g., any history of
             neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human
             Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS),
             or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
             (Exception: subjects with mild asthma were eligible for enrollment; subjects with
             moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids
             were not eligible for enrollment);

          -  who had epilepsy or any progressive neurological disease;

          -  who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any
             vaccine component;

          -  who had a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from (for example):

          -  receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic
             corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day
             prednisone or equivalent during any of 30 days prior to enrollment, or cancer
             chemotherapy);

          -  receipt of immunostimulants;

          -  receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
             derivatives within 90 days prior to enrollment and for the full length of the study;

          -  common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring
             6 weeks prior to vaccination;

          -  who were known to have a bleeding diathesis or any condition that could be associated
             with a prolonged bleeding time;

          -  who had Down syndrome or other known cytogenic disorders;

          -  whose families were planning to leave the area of the study site before the end of the
             study period;

          -  who had any condition that, in the opinion of the investigator, could interfere with
             the evaluation of the study objectives.