A norovirus vaccine study in childre

Phase 1

• Conditions: Prevention of gastroenteritis caused by norovirus; MedDRA version: 20.1Level: PTClassification code 10068189Term: Gastroenteritis norovirusSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-000778-20-FI
• Lead Sponsor: Takeda Vaccines, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-24
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

* Male and female subjects aged between 6 weeks and less than 9 years 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’s legally authorized representative (LAR) signs and dates a written, informed consent form (ICF) 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. An assent will also be obtained according to age appropriate country-specific regulations.
* Individuals 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: 840
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with a clinically significant active infection (as assessed by the investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the intended date of vaccination.
2. Subjects who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
3. Known hypersensitivity or allergy to investigational vaccine
4. Subjects with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the trial.
5. Subjects with a history of any progressive or severe neurologic disorder, seizure disorder, or neuroinflammatory disease (eg, Guillain-Barré syndrome).
6. Known or suspected impairment/alteration of immune function, including the following:
a. Children <18 months of age with history of repeated episodes of acute otitis media (AOM) in the first 6 months of life (AOM defined as a bulging tympanic membrane) and not to be confused with otitis media with effusion (OME).
b. Chronic use of oral steroids (equivalent to 20 mg/day prednisone for =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
c. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day for =2 weeks) within 60 days prior to Day 1.
d. Receipt of immunostimulants within 60 days prior to Day 1.
e. Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.
f. Receipt of immunosuppressive therapy within 6 months prior to Day 1.
g. Human immunodeficiency virus (HIV) infection or HIV-related disease.
h. Chronic Hepatitis B or C infection.
i. Heritable immunodeficiency.
7. Abnormalities of splenic or thymic function.
8. Subjects with a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
9. Subjects with any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
10. Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
11. Subjects who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial.
12. Subjects who are first degree relatives of individuals involved in trial conduct.
13. Subjects with a history of autoimmune disease.
14. There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (eg, body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for trial enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible

Study & Design

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