Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine; Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Tdap
Intervention description: The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 440.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; vaccines; adolescents; prevention; Meningitis

Summary:

      This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a
      meningococcal vaccine formulation in adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible to be enrolled into this study were male or female who completed study
        V102_02 (primary study), and:

          1. who were 11 to 18 years at the time of enrollment in primary study;

          2. who had given their written consent at the time of enrollment;

          3. who were available for all the visits scheduled in the study (ie, not planning to
             leave the area before the end of the study period);

          4. who were in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

        Exclusion Criteria:

          1. History of any meningococcal vaccine administration;

          2. Current or previous, confirmed or suspected disease caused by N meningitidis;

          3. Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N meningitidis infection within 60 days of enrollment;

          4. Significant acute or chronic infection within the previous 7 days or fever (defined as
             temperature >38°C) within the previous 3 days;

          5. Antibiotics within 7 days prior to enrollment or blood draw;

          6. Pregnancy or nursing (breastfeeding) mothers;

          7. Females of childbearing age who had not used or did not plan to use acceptable birth
             control measures, for the duration of the study. Oral, injected or implanted hormonal
             contraceptive, barrier methods (condom or diaphragm with spermicide); intrauterine
             device or sexual abstinence was considered acceptable forms of birth control. If
             sexually active the subject must have been using one of the accepted birth control
             methods at least two months prior to study entry;

          8. Any serious chronic or progressive disease (eg, neoplasm, diabetes, cardiac disease,
             hepatic disease, progressive neurological disease or seizure disorder; autoimmune
             disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome,
             blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure or severe
             malnutrition).

          9. Known or suspected impairment/alteration of the immune system, immunosuppressive
             therapy, including use of corticosteroids in immunosuppressive doses or chronic use of
             inhaled high-potency corticosteroids or immunostimulants within the previous 60 days.
             Use of topical corticosteroids administered during the study in limited areas (ie,
             eczema on knees or face or elbows) of the body was allowed;

         10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral
             immunoglobulin preparation within the previous 90 days;

         11. History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component;

         12. Individuals who received any other vaccines within 2 weeks (for inactivated vaccines)
             or 4 weeks (for live vaccines) prior to enrollment in this study or who were planning
             to receive any vaccine within 4 weeks from the study vaccines.

         13. Individuals participating in any clinical trial with another investigational product
             30 days prior to first study visit or had intent to participate in another clinical
             study at any time during the conduct of this study.

         14. Individuals who were part of study personnel or close family members conducting this
             study.

         15. Individuals with medical history or any illness that, in the opinion of the
             investigator, might interfere with the results of the study or posed additional risk
             to the subjects due to participation in the study.