A norovirus vaccine study

Phase 1

• Conditions: Prevention of gastroenteritis caused by norovirus; MedDRA version: 16.1Level: PTClassification code 10068189Term: Gastroenteritis norovirusSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-001419-64-BE
• Lead Sponsor: Takeda Vaccines (Montana), Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-04
• Study Completion: 2015-06-19
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified