Study to evaluate the immunogenicity and safety of Twinrix, Engerix-B and Havrix when administered with Menveo.

Conditions: 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: 14.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-001333-17-DE

Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 252

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:
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
ohistory of cancer
ocomplicated diabetes mellitus
oadvanced arteriosclerotic disease
oautoimmune disease
oHIV infection or AIDS
oblood dyscrasias
ocongestive heart failure
orenal failure
osevere 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):
oreceipt 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);
oreceipt of immunostimulants;
oreceipt 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.