To Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults MedDRA version: 14.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Female and male subjects eligible to be enrolled in this study are: • available for all study visits, • able to give written informed consent, • 18 years of age or older, and • generally in good health. Subjects with previous vaccination against hepatitis A and/or B, determined by history (interview of the subject) and/or by review of his or her vaccination card will be eligible to participate in the study if more than 5 years have elapsed since vaccination. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 252 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Individuals not eligible to be enrolled in the study are those: 1. who are breastfeeding; 2. who have 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 expect 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 is anticipated during the study period. (Exception: Influenza vaccine may be 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 have experienced fever (defined as body temperature = 38°C) within 3 days prior to enrollment. 8. who have any serious acute, chronic or progressive disease such as o history of cancer o complicated diabetes mellitus o advanced arteriosclerotic disease o autoimmune disease o HIV infection or AIDS o blood dyscrasias o congestive heart failure o renal failure o severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment.) 9. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; 10. who have 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 have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): o 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); o receipt of immunostimulants; o 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 are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 13. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 14. who are part of the study personnel or close family members of those conducting this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives: Primary To establish the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, measured by geometric mean titers (GMTs) on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously primed subjects. Safety Objectives 1. To describe the safety profile of combined hepatitis A/B virus vaccine given alone or concomitantly with MenACWY-CRM. 2. To describe the safety profile of MenACWY-CRM when given alone. Safety will be assessed for all subjects in terms of the frequency and percentage of all spontaneously reported adverse events (AEs) and serious adverse events (SAEs). ;Secondary Objective: Immunogenicity Objectives: Secondary 1. To assess hepatitis A and B vaccine seroprotection rates on day 57, elicited by 3 doses of hepatitis A and/or B vaccine, or on day 29 after a booster dose in previously primed subjects, given with or without MenACWY-CRM. 2. To assess seroresponse rates elicited by MenACWY-CRM on Day 29 when administered concomitantly with combined hepatitis A/B vaccine or given alone. 3. To assess the immune response of MenACWY-CRM in terms of geometric mean titers (GMTs) on day 29 when administered concomitantly with combined hepatitis A/B vaccine or given alone. ;Primary end point(s): Immunogenicity Endpoints Primary Endpoints • Post immunization geometric mean concentrations (GMCs) of anti-HAV antibodies 28 days after primary or booster immunization. • Post immunization geometric mean concentrations (GMCs) of antiHBsAg antibodies 28 days after primary or booster immunization. Safety Endpoints Safety will be assessed for all subjects in terms of the frequency and percentage of spontaneously reported adverse events (AEs) and serious adverse events (SAEs). SAEs will be collected from the time the subject signs the informed consent until he or she stops study participation. ;Timepoint(s) of evaluation of this end poin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints • Percentage of subjects with anti-HAV antibody concentration = 20 mIU/mL or 33 mIU/mL, depending on which immunoassay is used, 28 days after primary or booster immunization. • Percentage of subjects with anti-HBsAg antibody concentration = 10 mIU/mL, 28 days after primary or booster immunization. • Geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29. • Seroresponse rates for meningococcal serogroups A, C, W and Y on day 29. For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a post-vaccination hSBA titer = 1:8; for a subject with a baseline hSBA titer = 1:4, seroresponse is defined as a post-vaccination hSBA titer of at least 4 times the baseline. ;Timepoint(s) of evaluation of this end point: one month | — |
Countries
Germany
Contacts
Public ContactRegulatory Affairs Manager
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed