Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Bexsero®; Routine vaccines
Intervention description: Four doses administered in the anterolateral area of the right or left thigh.; Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Infants; Meningococcal B Recombinant Vaccine

Summary:

      Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK
      Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when
      concomitantly administered with routine vaccines in healthy infants in Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. healthy 2-month old infants (55-89 days, inclusive), who were 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 has given written informed consent after the nature
             of the study has been explained;

          3. available for all the visits scheduled in the study;

          4. in good health as determined by medical history, physical examination and clinical
             judgment of the investigator.

        Exclusion Criteria:

          1. History of any meningococcal vaccine administration;

          2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell),
             Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), Pneumococcal,
             MMR or varicella antigens;

          3. Previous ascertained or suspected disease caused by N. meningitidis;

          4. Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis;

          5. History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component;

          6. Significant acute or chronic infection within the previous 7 days or body temperature
             higher or equal to 38C degrees within the previous day;

          7. Antibiotics within 6 days prior to enrollment;

          8. Any serious chronic or progressive disease according to the judgment of the
             investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac
             disease, hepatic disease, progressive neurological disease or seizure, either
             associated with fever or as part of an underlying neurological disorder or syndrome,
             autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of
             cardiac or renal failure or severe malnutrition);

          9. Known or suspected impairment/alteration of the immune system, immunosuppressive
             therapy, use of systemic corticosteroids or chronic use of inhaled high-potency
             corticosteroids since birth;

         10. Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation;

         11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of
             rotavirus vaccine, influenza vaccine and second HepB vaccine), within 28 days prior
             and throughout the study period. Furthermore, subjects must have received HepB vaccine
             preferably at 0, 1 month of age, with the second dose at least 14 days prior to study
             vaccination. Influenza vaccine should be administered at least 14 days before or 14
             days after study vaccination; Rotavirus vaccine may be administered during the study
             as per local practice.

         12. Participation in another clinical trial since birth or planned for during study;

         13. Family members and household members of research staff;

         14. Any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives.