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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01453348
First received: October 3, 2011
Last updated: February 6, 2014
Last verified: February 2014

October 3, 2011
February 6, 2014
October 2011
January 2012   (final data collection date for primary outcome measure)
Geometric Mean antiHAV and antiHBV Concentrations, 28 Days After Primary and Booster Vaccination [ Time Frame: Day 57 (previously unprimed subjects) Day 29 (previously primed subjects) postvaccination. ] [ Designated as safety issue: No ]
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.
Geometric mean concentration (GMC) of anti-HAV antibodies and anti-HBsAg antibodies [ Time Frame: 56 or 28 days post first vaccination depending on the subject's hepatitis A and B vaccination history before enrollment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01453348 on ClinicalTrials.gov Archive Site
  • Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination [ Time Frame: 28 days post primary or booster vaccination. ] [ Designated as safety issue: No ]
    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.
  • Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29 [ Time Frame: 28 days post vaccination (day 29). ] [ Designated as safety issue: No ]

    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 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.

  • Geometric Mean Human Serum Bactericidal Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29 [ Time Frame: 28 days post vaccination (day 29). ] [ Designated as safety issue: No ]
    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.
  • Percentages of Subjects With Unsolicited Adverse Events [ Time Frame: Day 1 to Day 57. ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of percentage of all spontaneously reported adverse events collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).
  • Percentage of subjects with anti-HAV antibody concentration of >-20 mIU/mL or 33 mIU/mL, depending on the immunoassay. [ Time Frame: 56 or 28 days post first vaccination depending on the subject's hepatitis A and B vaccination history before enrollment ] [ Designated as safety issue: No ]
  • Percentage of subjects with anti-HBsAg antibody concentration >-10mIU/ml [ Time Frame: 56 or 28 days post first vaccination depending on the subject's hepatitis A and B vaccination history before enrollment ] [ Designated as safety issue: No ]
  • Geometric mean titers(GMTs)of antibody to meningococcal serogroups A,C,W and Y [ Time Frame: 28 days post first vaccination ] [ Designated as safety issue: No ]
  • Number of subjects with spontaneously reported adverse events. [ Time Frame: 56 or 28 days post first vaccination depending on the subject's hepatitis A and B vaccination history before enrollment ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious adverse events. [ Time Frame: 56 or 28 days post first vaccination depending on the subject's hepatitis A and B vaccination history before enrollment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningococcal Disease
  • Meningococcal Meningitis
  • Hepatitis A
  • Hepatitis B
  • Biological: MenACWY-CRM
    Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly on day 1.
  • Biological: Combined inactivated hepatitis A and recombinant hepatitis B vaccine
    Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered intramuscularly on days 1, 8 and 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.
  • Biological: Recombinant hepatitis B vaccine
    Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
  • Biological: Inactivated hepatitis A vaccine
    Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
  • Active Comparator: Group 1
    This group will receive hepatitis A and/or B alone on the different visits.
    Interventions:
    • Biological: Combined inactivated hepatitis A and recombinant hepatitis B vaccine
    • Biological: Recombinant hepatitis B vaccine
    • Biological: Inactivated hepatitis A vaccine
  • Active Comparator: Group 2
    This group will receive hepatitis A and/or B vaccine concomitantly with MenACWY-CRM
    Interventions:
    • Biological: MenACWY-CRM
    • Biological: Combined inactivated hepatitis A and recombinant hepatitis B vaccine
    • Biological: Recombinant hepatitis B vaccine
    • Biological: Inactivated hepatitis A vaccine
  • Active Comparator: Group 3
    This group will receive only MenACWY-CRM
    Intervention: Biological: MenACWY-CRM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

  1. Between 18 and 64 years of age inclusive and who have 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, have a negative urine pregnancy test.

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:

    • 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 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):

    • 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 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.     
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01453348
V59_53, 2011-001333-17
Not Provided
Novartis
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP