Status:
COMPLETED
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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
- 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
- Individuals not eligible to be enrolled in the study were those:
- Who were breastfeeding.
- Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
- Who received previous immunization with any meningococcal vaccine.
- 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.
- 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.
- 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).
- 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.
- 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).
- Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
- 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.
- 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.
- Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
- Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
- Who were part of the study personnel or close family members of those conducting this study.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01453348
Start Date
October 1 2011
End Date
January 1 2012
Last Update
June 8 2017
Active Locations (4)
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1
03, Novartis Investigational Site
Berlin, Germany, 10117
2
02, Novartis Investigational Site
Hamburg, Germany, 20359
3
01, Novartis Investigational Site
München, Germany, 80802
4
04, Novartis Investigational Site
Rostock, Germany, 18057