Trial Outcomes & Findings for Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults (NCT NCT02669121)
NCT ID: NCT02669121
Last Updated: 2021-06-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4748 participants
Primary outcome timeframe
Up to Day 47
Results posted on
2021-06-10
Participant Flow
Participants took part in the study at a single investigative site in the United States from 14 June 2016 to 16 June 2018.
Healthy volunteers were enrolled in the study and randomized in 1:1 ratio to receive Norovirus GI.1/GII.4 Bivalent VLP Vaccine or Placebo.
Participant milestones
| Measure |
Placebo
NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
2377
|
2371
|
|
Overall Study
Treated (Safety Analysis Set)
|
2357
|
2355
|
|
Overall Study
COMPLETED
|
2087
|
2089
|
|
Overall Study
NOT COMPLETED
|
290
|
282
|
Reasons for withdrawal
| Measure |
Placebo
NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
15
|
27
|
|
Overall Study
Withdrawal by Subject
|
132
|
140
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Discharged from US Military Active Service
|
117
|
91
|
|
Overall Study
Reason not Specified
|
22
|
18
|
Baseline Characteristics
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=2377 Participants
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2371 Participants
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
Total
n=4748 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.3 years
STANDARD_DEVIATION 2.95 • n=5 Participants
|
20.2 years
STANDARD_DEVIATION 2.74 • n=7 Participants
|
20.3 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
423 Participants
n=5 Participants
|
437 Participants
n=7 Participants
|
860 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1954 Participants
n=5 Participants
|
1934 Participants
n=7 Participants
|
3888 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
521 Participants
n=5 Participants
|
484 Participants
n=7 Participants
|
1005 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1856 Participants
n=5 Participants
|
1887 Participants
n=7 Participants
|
3743 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
351 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
706 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1668 Participants
n=5 Participants
|
1667 Participants
n=7 Participants
|
3335 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
165 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2377 Participants
n=5 Participants
|
2371 Participants
n=7 Participants
|
4748 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 47Population: Full Analysis Set included all participants who were randomized and received the trial dose.
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.
Outcome measures
| Measure |
Placebo
n=2357 Participants
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 Participants
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
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)
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 47Population: Full Analysis Set included all participants who were randomized and received the trial dose.
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 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.
Outcome measures
| Measure |
Placebo
n=2357 Participants
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 Participants
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection)
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Day 47Population: Full Analysis Set included all participants who were randomized and received the trial dose.
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 RT-PCR. The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains including co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.
Outcome measures
| Measure |
Placebo
n=2357 Participants
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 Participants
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection)
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Day 47Population: Full Analysis Set included all participants who were randomized and received the trial dose.
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 RT-PCR. The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains including co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.
Outcome measures
| Measure |
Placebo
n=2357 Participants
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 Participants
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
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)
|
5 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 35 serious events
Other events: 88 other events
Deaths: 0 deaths
NoV GI.1/GII.4 Bivalent VLP Vaccine
Serious events: 29 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=2357 participants at risk
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 participants at risk
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
General disorders
Non-cardiac chest pain
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
General disorders
Pyrexia
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Pneumonia
|
0.13%
3/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Infectious mononucleosis
|
0.08%
2/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Subcutaneous abscess
|
0.08%
2/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Abscess jaw
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Abscess oral
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Bronchitis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Chlamydial infection
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Helicobacter gastritis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Parotitis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Tooth abscess
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Varicella
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Infections and infestations
Viral infection
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.08%
2/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.13%
3/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Nervous system disorders
Syncope
|
0.08%
2/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Nervous system disorders
Myelopathy
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Adjustment disorder
|
0.21%
5/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.13%
3/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.08%
2/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Major depression
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
2/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Depression
|
0.00%
0/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.04%
1/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Psychiatric disorders
Panic attack
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
0.00%
0/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
Other adverse events
| Measure |
Placebo
n=2357 participants at risk
NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1.
|
NoV GI.1/GII.4 Bivalent VLP Vaccine
n=2355 participants at risk
NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
45/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
2.4%
57/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
57/2357 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
2.3%
55/2355 • From Day 1 up to the end of the study (Up to 47 days)
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received trial dose (NoV GI.1/GII.4 bivalent VLP vaccine or saline placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER