Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
Condition: Prevention of Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation); MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation); MenACWY PS (MenACWY-CRM, polysaccharide vaccine); HBV (Hepatitis B vaccine); Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197); MMR (Measles, Mumps and Rubella vaccine); DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine); Menjugate (Men C conjugated vaccine)
Intervention description: MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.; MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.; MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.; Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.; Prevnar was administered IM in the anterolateral area of the left thigh.; MMR at 12 month of age, administered in the left arm.; DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.; Menjugate was injected IM in the anterolateral area of the right thigh.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, immunogenicity and induction of immune
      memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate
      Vaccine administered to healthy infants.
    

Eligibility criteria:

        Inclusion Criteria

        Individuals eligible for enrollment in this study were male, and female infants:

          -  Who were healthy 2-month old infants (55-89 days, inclusive) born after full term
             pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg;

          -  For whom a parent/legal guardian has given written informed consent after the nature
             of the study has been explained;

          -  Who were available for all the visits scheduled in the study;

          -  Who were in good health as determined by:

               -  Medical history;

               -  Physical examination;

               -  Clinical judgment of the investigator.

        Exclusion Criteria

        Ineligible for the study were infants:

          -  Whose parents/legal guardians were unwilling, or unable to give written informed
             consent for the subject to participate in the study;

          -  Who previously received any meningococcal vaccine;

          -  Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV,
             HBV, H influenzae type b (Hib), or Pneumococcus;

          -  Who had a previously ascertained or suspected disease caused by N meningitidis, C
             diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis
             (history of laboratory-confirmed or clinical condition of spasmodic cough for a period
             ≥ 2 weeks associated with apnea or whooping cough);

          -  Who had household contact with and/or intimate exposure to an individual with
             laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C
             diphtheriae, Polio, or pneumococcal infection since birth;

          -  Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic
             reaction after previous vaccinations, or known hypersensitivity to any vaccine
             component;

          -  Who had experienced significant acute or chronic infection within the previous 7 days,
             or fever (≥ 38.0°C) within the previous 3 days;

          -  Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or
             chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition,
             or insulin-dependent diabetes); or progressive neurological disease; or a genetic
             anomaly or known cytogenic disorders (e.g., Downs syndrome);

          -  Who had a known or suspected autoimmune disease or impairment /alteration of immune
             function resulting from (for example):

               -  receipt of any immunosuppressive therapy since birth;

               -  receipt of immunostimulant since birth;

               -  receipt of any systemic corticosteroid since birth.

          -  Who had a suspected or known HIV infection, or HIV-related disease;

          -  Who had ever received blood, blood products and/or plasma derivatives, or any
             parenteral immunoglobulin preparation;

          -  Who had a known bleeding diathesis, or any condition that may be associated with a
             prolonged bleeding time;

          -  Who had a history of seizure disorder:

               -  Febrile seizure;

               -  Any other seizure disorder.

          -  Who had taken systemic antibiotics (either oral or parenteral) within the previous 14
             days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic
             [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be
             enrolled 7 days following the last dose);

          -  Who with their parents/legal guardians 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, might interfere with
             the evaluation of the study objectives;

          -  Who had taken any antipyretic medication in the previous 6 hours.