Clinical trial NCT01453348: Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Hepatitis A
Hepatitis B
Keywords: meningococcal
conjugate
vaccine
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-10-17
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

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

1. Who were breastfeeding.
2. Who had 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 expected 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 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).
7. 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.
8. 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).
9. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
10. 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.
11. 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.
12. Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
13. Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
14. Who were part of the study personnel or close family members of those conducting this study.

Primary outcomes:
measure: Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
timeFrame: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Secondary outcomes:
measure: Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination
timeFrame: 28 days post primary or booster vaccination.
measure: Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29
timeFrame: 28 days postvaccination (day 29).
measure: hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29
timeFrame: 28 days post vaccination (day 29).
measure: Percentages of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Day 1 to day 57.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 03, Novartis Investigational Site
city: Hamburg
country: Germany
facility: 02, Novartis Investigational Site
city: München
country: Germany
facility: 01, Novartis Investigational Site
city: Rostock
country: Germany
facility: 04, Novartis Investigational Site
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Alberer M, Burchard G, Jelinek T, Reisinger EC, Meyer S, Forleo-Neto E, Dagnew AF, Arora AK. Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. J Travel Med. 2015 Mar-Apr;22(2):105-14. doi: 10.1111/jtm.12180. Epub 2014 Dec 7.