A Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 BivalentVirus- Vaccine
- Conditions
- ong-Term Immunogenicity Follow-up Trial of adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle VaccineMedDRA version: 20.0Level: LLTClassification code 10062371Term: Active immunizationSystem Organ Class: 100000022894Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-004288-37-BE
- Lead Sponsor
- Takeda Vaccines, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. The subject is aged over 18 years.
2. Male and female subjects who previously received at least 1 dose of NoV vaccine in trials NOR-107, NOR-210, NOR-204 and NOR-222, have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.
3. The subject 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.
4. Individuals who can comply with trial procedures and are available for the duration of follow-up
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 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
Any subject who meets any of the following criteria will not qualify for entry into the trial:
1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
2. In the opinion of the investigator, the subject is not medically eligible to provide blood specimens.
3. Individuals with behavioural 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.
There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., temperature elevation or recent vaccine). Under these circumstances,
eligibility for trial enrolment may be considered 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
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the humoral response after at least 1 dose of NoV vaccine up to 5 years after IM injection as measured by histo-blood group antigen (HBGA) blocking assay.;Secondary Objective: To evaluate the humoral response after at least 1 dose of NoV vaccine up to 5 years after IM injection as measured by total-immunoglobulin (pan-Ig) enzyme-linked immunosorbent assay (ELISA);Primary end point(s): - Geometric Mean Blocking Titers (GMBT50) of anti-norovirus GI.1 VLP antibodies.<br>- GMBT50 of anti-norovirus GII.4 VLP antibodies.;Timepoint(s) of evaluation of this end point: Yearly intervals from at least 1 year and up to 5 years after primary vaccination.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints (immunogenicity) for this trial, as measured by pan-Ig ELISA are:<br>- Geometric Mean Titers (GMT) of anti-norovirus GI.1 VLP antibodies.<br>- GMT of GII.4 VLP antibodies;Timepoint(s) of evaluation of this end point: Yearly intervals from at least 1 year and up to 5 years after primary vaccination.