A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM; DTaP-IPV/Hib; HBV; PCV; MMR
Intervention description: One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.; IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.; IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.; IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.; Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 529.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MenACWY conjugate vaccine in infants; Meningococcal vaccine in infants; MenACWY

Summary:

      This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and
      non-interference of concomitant routine vaccines by MenACWY in an infant age group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Two month-old infants, born after a full-term pregnancy with an estimated gestational
             age ≥37 weeks and a birth weight ≥2.5 kg.

          2. Documented written informed consent provided by the parent/legal representative after
             the nature of the study had been explained.

          3. Parent/legal representative was available for all visits scheduled in the study.

          4. Subjects were in good health as determined by:

               1. medical history

               2. physical assessment

               3. clinical judgment of the investigator

        Exclusion Criteria:

          1. Subjects who previously received any meningococcal vaccines or vaccines against
             diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or
             pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are
             permitted.

          2. Subjects who had a previous confirmed 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 paroxysmal cough for a
             period of longer than or equal to 2 weeks associated with apnea or whooping).

          3. Subjects who had household contact with and/or intimate exposure to an individual with
             laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or
             pneumococcal infection at any time since birth.

          4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic
             reaction after previous vaccinations or known hypersensitivity to any vaccine
             component.

          5. Subjects who had experienced significant acute or chronic infection within the
             previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the
             previous 3 days.

          6. Subjects who had any serious acute or chronic disease, neurological disease including
             seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).

          7. Subjects who had a known or suspected autoimmune disease or persistent
             impairment/alteration of immune function.

          8. Subjects who had a suspected or known HIV infection or were born to a mother known to
             be HIV positive.

          9. Subjects who had ever received blood, blood products and/or plasma derivatives or any
             parenteral immunoglobulin preparation (including Hepatitis B immune globulin).

         10. Subjects who had a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

         11. Subjects who with their parents/legal representatives were planning to leave the area
             of the study site before the end of the study period.

         12. Subjects who had any condition which, in the opinion of the investigator, might
             interfere with the evaluation of the study objectives.

         13. Subjects who received any investigational agents or vaccines since birth or who expect
             to receive an investigational agent or vaccine prior to the completion of the study.

         14. Subjects who were relatives of site research staff working on this study.