EUCTR2005-003526-25-DE
Active, not recruiting
Not Applicable
Safety and immunogenicity of concomitant vaccination with IC51 and Havrix 1440 in healthy subjects. A single-blind randomised, controlled phase 3 study.
DrugsHAVRIX 1440
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Intercell AG
- Enrollment
- 192
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-At least 18 years of age
- •\-In female subjects either childbearing potential terminated by surgery or one year post\-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in protocol section 6\.4
- •\-Written informed consent obtained prior to study entry (subjects should give their consent themselves. Consent by legal representatives is allowed.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •?History of clinical manifestation of any flavivirus infection
- •?History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti\-JEV neutralizing antibody titer ? 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per\-protocol analysis)
- •?History of any previous Hepatitis A vaccination
- •?Use of any other investigational or non\-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •?Planned administration of another vaccine during the study period
- •?Immunodeficiency including post\-organ\-transplantation or immunosuppressive therapy
- •?A family history of congenital or hereditary immunodeficiency
- •?History of autoimmune disease
- •?Administration of chronic (defined as more than 14 days) immunosuppressants or other immune\-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ? 0\.05 mg/kg/day. Topical and inhaled steroids are allowed.)
- •?Any acute infections within 4 weeks prior to enrollment
Outcomes
Primary Outcomes
Not specified
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