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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 ...
NoV Placebo-matching Saline is the placebo comparator used in a Takeda Pharmaceutical Company Limited norovirus vaccine study. It is saline formulated to match the appearance of the norovirus GI.1/GII.4 bivalent virus-like particle vaccine so participants and investigators cannot tell which preparation was given. It contains no active vaccine component.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer associated with NoV Placebo-matching Saline. It was produced as the matching placebo for Takeda's norovirus vaccine program rather than as a standalone therapeutic product.
NoV Placebo-matching Saline was used in a Phase 2 clinical trial. It is not an investigational therapeutic itself; it serves as the control arm in that study. The trial has been completed, and no trials of this placebo are currently active.
NoV Placebo-matching Saline was the placebo control in NCT02669121, titled Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults. The Phase 2 study enrolled 4,748 healthy volunteers aged 18 years and older in the United States and has completed.
In NCT02669121, NoV Placebo-matching Saline was given to the control group in a randomized, double-blind, placebo-controlled design. Because it matched the norovirus GI.1/GII.4 bivalent virus-like particle vaccine in appearance, blinding was maintained while vaccine efficacy and immunogenicity were assessed in healthy adult volunteers.