Approval Probability
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Adjusted LOA
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NoV Placebo-matching Saline · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1. |
| NoV GI.1/GII.4 Bivalent VLP Vaccine | EXPERIMENTAL | NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1. |
| Name | Type | Description |
|---|---|---|
| NoV Placebo-matching Saline | BIOLOGICAL | NoV placebo-matching saline (0.9% sodium chloride). |
| NoV GI.1/GII.4 Bivalent VLP Vaccine | BIOLOGICAL | NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3. |
Inclusion Criteria: 1. 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. 2. Male or female participants, 18 ...