Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Condition: Meningococcal Disease; Meningococcal Meningitis; Hepatitis A; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Meningococcal Infections; Meningitis, Meningococcal; Hepatitis; Meningitis
Intervention: MenACWY-CRM; Combined inactivated hepatitis A & recombinant hepatitis B; Recombinant hepatitis B vaccine; Inactivated hepatitis A vaccine
Intervention description: Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.; Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 & 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.; Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29; Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal; conjugate; vaccine; adults

Summary:

      This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine
      given alone or concomitantly with MenACWY-CRM to healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment in this study were female and male subjects who had
        shown to be healthy and who were:

          1. Between 18 and 64 years of age inclusive and who had given their written informed
             consent;

          2. Available for all visits and telephone calls scheduled for the study;

          3. In good health as determined by medical history, physical examination and clinical
             judgment of the investigator;

          4. For female subjects, had a negative urine pregnancy test.

        Exclusion Criteria:

        Individuals not eligible to be enrolled in the study were those:

          1. Who were breastfeeding.

          2. Who had a previous personal history of Neisseria meningitidis, hepatitis A or
             hepatitis B infection.

          3. Who received previous immunization with any meningococcal vaccine.

          4. Who received previous hepatitis A and/or B vaccination, determined by history
             (interview of the subject) and/or by review of his or her vaccination card, if less
             than 5 years have elapsed since vaccination.

          5. Who received investigational agents or vaccines within 30 days prior to enrollment or
             who expected to receive an investigational agent or vaccine prior to completion of the
             study.

          6. Who received live licensed vaccines within 30 days and inactive vaccine within 15 days
             prior to enrollment or for whom receipt of a licensed vaccine was anticipated during
             the study period (Exception: Influenza vaccine might have been administered up to 15
             days prior to each study immunization and no less than 15 days after each study
             immunization).

          7. Who experienced, within the 7 days prior to enrollment, significant acute infection
             (for example requiring systemic antibiotic treatment or antiviral therapy) or had
             experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to
             enrollment.

          8. Who had any serious acute, chronic or progressive disease such as:

               -  History of cancer

               -  Complicated diabetes mellitus

               -  Advanced arteriosclerotic disease

               -  Autoimmune disease

               -  HIV infection or AIDS

               -  Blood dyscrasias

               -  Congestive heart failure

               -  Renal failure

               -  Severe malnutrition (Note: Subjects with mild asthma were eligible for
                  enrollment. Subjects with moderate or severe asthma requiring routine use of
                  inhaled or systemic corticosteroids were not eligible for enrollment).

          9. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre
             syndrome.

         10. Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine
             component, including but not limited to latex allergy and antibiotic allergy.

         11. Who had a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from (for example):

               -  Receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic
                  corticosteroids administered for more than 5 days, or in a daily dose > 1
                  mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or
                  cancer chemotherapy);

               -  Receipt of immunostimulants;

               -  Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivatives within 90 days prior to enrollment and for the full length of the
                  study.

         12. Who were known to have a bleeding diathesis, or any condition that might have been
             associated with a prolonged bleeding time.

         13. Who had any condition that, in the opinion of the investigator, might have interfered
             with the evaluation of the study objectives.

         14. Who were part of the study personnel or close family members of those conducting this
             study.