Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Takeda
- Enrollment
- 4748
- Locations
- 1
- Primary Endpoint
- Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
The vaccine being tested in this study is called NoV GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide. The norovirus vaccine is being tested to prevent AGE due to genotype-specific (GI.1 and GII.4) norovirus strains in healthy participants recruited from a US military training installation. This study will look at the illness rate of AGE occurring \> 7 days after dosing due to genotype-specific (GI.1 or GII.4) NoV strains represented in the vaccine. The study will enroll between 2800 and 8700 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Norovirus GI.1/GII.4 Bivalent VLP Vaccine * Placebo (dummy inactive solution) - this is a liquid that looks similar to the study drug but has no active ingredient All participants will receive one dose of study medication on Day 1 administered via intramuscular injection. This multi-center trial will be conducted in the United States at select military locations. The overall time to participate in this study is up to 45 days for participants in the navy 53 days for participants in the Air Force, and 72 days for participants in the marines. Participants will make multiple visits to the clinic, including a final visit on the last day of study participation (Day 45, 53 or 72) for a follow-up assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection)
Time Frame: Up to Day 47
Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by reverse transcriptase polymerase chain reaction (RT-PCR). The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.
Secondary Outcomes
- Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection)(Up to Day 47)
- Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection)(Up to Day 47)
- Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection)(Up to Day 47)