Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
Enrollment
Sex
Ages
Volunteers
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:
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Who were breastfeeding.
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Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
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Who received previous immunization with any meningococcal vaccine.
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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.
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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.
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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).
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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.
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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).
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Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
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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.
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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.
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Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
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Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
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Who were part of the study personnel or close family members of those conducting this study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
252 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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