This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
252
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
03, Novartis Investigational Site
Berlin, Germany
02, Novartis Investigational Site
Hamburg, Germany
01, Novartis Investigational Site
München, Germany
04, Novartis Investigational Site
Rostock, Germany
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
Time frame: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.
Time frame: 28 days post primary or booster vaccination.
Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone. For a subject with a baseline hSBA titer \< 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 28 days postvaccination (day 29).
hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.
Time frame: 28 days post vaccination (day 29).
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Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Percentages of Subjects With Unsolicited Adverse Events (AEs)
Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).
Time frame: Day 1 to day 57.