Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition: Healthy
Intervention: rMenB; rMenB+OMV; DTaP-Hib-IPV; PC7; MenC-CRM; MenC-Hib; MMR
Intervention description: One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.; One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.; Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.; IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.; MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.; MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.; IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left 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: 147.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; prevention; vaccination

Summary:

      This study was aimed to explore safety and immunogenicity of two formulations of a
      Meningococcal B Vaccine when administered to healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible to be enrolled in the study:

          1. 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;

          2. for whom a parent/legal guardian had provided written informed consent after the
             nature of the study had been explained;

          3. those available for all the visits scheduled in the study;

          4. those in good health as determined by:

               1. medical history

               2. physical examination

               3. clinical judgment of the investigator

        Exclusion Criteria:

        Individuals were not to be enrolled into the study:

        1. whose parents/legal guardians were unwilling or unable to give written informed consent
        to participate in the study; 2. who had previously received any meningococcal B vaccine; 3.
        who had received prior vaccination with Diphtheria Tetanus Pertussis (DTP) (acellular or
        whole cell), Inactivated Polio Vaccine (IPV) or Oral Polio Vaccine (OPV), H influenzae type
        b (Hib) or Heptavalent Pneumococcal Conjugate (PC7) vaccine; 4. who had a previous
        ascertained or suspected disease caused by N meningitidis, S pneumoniae, C diphtheriae,
        tetani, Poliovirus, Hib, or B pertussis (history of laboratory confirmed, or clinical
        condition of spasmodic cough for a period ≥2weeks associated with apnea or whooping); 5.
        who had household contact with and/or intimate exposure to an individual with laboratory
        confirmed N meningitidis, B pertussis, Hib, C diphtheriae or Polio infection since birth;
        6. who had a history of any anaphylactic shock, asthma, urticaria or other allergic
        reaction after previous vaccinations or known hypersensitivity to any vaccine component; 7.
        who had experienced significant acute or chronic infection within the previous 7 days or
        had experienced fever (≥38.0°C) within the previous 3 days; 8. who had any present or
        suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure,
        hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive
        neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's
        syndrome); 9. who had leukemia, lymphomas; 10. who had a known or suspected autoimmune
        disease or impairment/alteration of immune function resulting from (for example):

          1. receipt of any immunosuppressive therapy since birth

          2. receipt of immunostimulants since birth

          3. receipt of any systemic corticosteroid since birth 11. with a suspected or known HIV
             infection or HIV related disease; 12. who had ever received blood, blood products
             and/or plasma derivatives or any parenteral immunoglobulin preparation from birth and
             for the full length of the study; 13. with a known bleeding diathesis, or any
             condition that might be associated with a prolonged bleeding time; 14. who had
             experienced any seizure, either associated with fever or as part of an underlying
             neurological disorder or syndrome 15. who had taken antibiotics within 7 days prior to
             enrollment (exception: antibiotics taken once daily within 14 days after the last
             dose); 16. who had either received, or for whom there was intent to immunize with any
             other vaccine(s), with respect to the study vaccines, within 30 days prior and
             throughout the study period; 17. who had ever received another investigational agent
             from birth prior to enrollment and unwilling to refuse participation in another
             investigational trial through the end of the study; 18. whose parents/legal guardians,
             were planning to leave the area of the study site before the end of the study period;
             19. with any condition which, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives.