Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.

Key facts

Study ID

NCT02669121

Run by

Takeda

People needed

4748

Starts

2016-06-14

Expected to finish

2018-06-16

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant signs and dates a written, informed consent form 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.
• Male or female participants, 18 to 49 years of age.
• Is in good health at the time of entry into the trial as determined by medical history and the clinical judgment of the investigator.
• Can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if…

• Pregnancy.
• Has known hypersensitivity to any of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle (VLP) vaccine components (including excipients).
• Has known hypersensitivity or allergy to any of the licensed required concomitant vaccine components to be administered (including excipients of these vaccines).
• Has any condition or circumstance that the investigator determines would interfere with trial evaluation or interpretation.
• Has known or suspected impairment or alteration of immune function.
• Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
• Has a history of body temperature of 38.0°C (100.4°F) or higher within 3 days of intended trial vaccination.
• Has received blood, blood products, and/or plasma derivatives or any parenteral immunoglobulin antibody preparation in the past 3 months.
• Immunosuppressive therapy within 3 months or systemic (e.g., oral or parenteral) corticosteroid treatment within 60 days prior to investigational trial dose administration.
• Is participating in any clinical trial with another investigational product 30 days prior to the first trial visit or intending to participate in another clinical trial at any time during the conduct of this trial.
• Participants who are first-degree relatives of individuals involved in the conduct of the trial.
• Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g. Guillain-Barré syndrome).
• Has history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
• Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial with the exception of routine immunizations as per Military Procedures.
• If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:
• Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
• Acceptable birth control methods are defined as one or more of the following:
• Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
• Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
• Intrauterine device (IUD).
• Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
• If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" from Day 1 through 6 months after the last dose of trial vaccine. In addition, they must be advised not to donate ova during this period.
• Has any positive or indeterminate pregnancy test.

Where it is running

• Great Lakes Naval Station — Great Lakes, Illinois, United States

Full record on ClinicalTrials.gov

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