Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

Inclusion criteria

Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:

• Between 18 and 64 years of age inclusive and who had given their written informed consent;
• Available for all visits and telephone calls scheduled for the study;
• In good health as determined by medical history, physical examination and clinical judgment of the investigator;
• For female subjects, had a negative urine pregnancy test.

Exclusion criteria

Individuals not eligible to be enrolled in the study were those:

• Who were breastfeeding.
• Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
• Who received previous immunization with any meningococcal vaccine.
• 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.
• 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.
• 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).
• 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.
• 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).
• Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
• 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.
• 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.
• Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
• Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
• Who were part of the study personnel or close family members of those conducting this study.