EUCTR2013-001419-64-BE
Active, not recruiting
Phase 1
A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted with or without Monophosphoryl Lipid A and Aluminum Hydroxide in Adolescents and Adults - NOR-107 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Takeda Vaccines (Montana), Inc.0 sites420 target enrollmentDecember 4, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of gastroenteritis caused by norovirus
- Sponsor
- Takeda Vaccines (Montana), Inc.
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male and female subjects between 17 and 64 years of age at the time of enrollment.
- •\- Subjects who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
- •\- The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form (and assent form in the case of adolescents) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- •\- Subjects who can comply with trial procedures and are available for the duration of the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 400
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Subjects who have received any vaccination that included Hepatitis A vaccine within the last 5 years.
- •\- Subjects with known hypersensitivity to any of the vaccine components.
- •\- Subjects with contraindications, warnings, and/or precautions to vaccinations with Havrix.
- •\- Subjects with known or suspected impairment/alteration of immune function.
- •\- Female subjects who are pregnant or breastfeeding
Outcomes
Primary Outcomes
Not specified
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