Trial Outcomes & Findings for Norovirus Bivalent-Vaccine Efficacy Study (NCT NCT01609257)
NCT ID: NCT01609257
Last Updated: 2019-01-09
Results Overview
Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR \>400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.
COMPLETED
PHASE1/PHASE2
132 participants
Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
2019-01-09
Participant Flow
Participants took part in the study at 5 investigative sites in the United States from 16 June 2012 to 18 March 2014.
Healthy Volunteers were enrolled equally in 1 of 2 treatment groups, Norovirus Bivalent VLP Vaccine or Placebo.
Participant milestones
| Measure |
Norovirus Bivalent VLP Vaccine
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
65
|
|
Overall Study
Received 2 Doses
|
63
|
64
|
|
Overall Study
Received Challenge Product
|
56
|
53
|
|
Overall Study
COMPLETED
|
61
|
57
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Norovirus Bivalent VLP Vaccine
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Voluntary Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Non-compliance/Protocol deviation
|
4
|
6
|
Baseline Characteristics
Norovirus Bivalent-Vaccine Efficacy Study
Baseline characteristics by cohort
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
65 participants
n=5 Participants
|
63 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
65 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)Population: Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.
Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR \>400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=56 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=53 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer
|
26.8 percentage of participants
|
32.1 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days post-dose 1Population: MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=66 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=64 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1
|
66.7 percentage of participants
Interval 54.0 to 77.8
|
28.1 percentage of participants
Interval 17.6 to 40.8
|
PRIMARY outcome
Timeframe: Within 7 days post-dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.
Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2
|
54.0 percentage of participants
Interval 40.9 to 66.6
|
20.6 percentage of participants
Interval 11.5 to 32.7
|
PRIMARY outcome
Timeframe: Within 7 days post-dose 1Population: MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.
Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=66 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=64 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1
|
36.4 percentage of particpants
Interval 24.9 to 49.1
|
32.8 percentage of particpants
Interval 21.6 to 45.7
|
PRIMARY outcome
Timeframe: Within 7 days post-dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.
Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2
|
30.2 percentage of particpants
Interval 19.2 to 43.0
|
19.0 percentage of particpants
Interval 10.2 to 30.9
|
PRIMARY outcome
Timeframe: 365 Days Following Dose 2 (Up to 393 days)Population: MITT population included all participants who received at least one dose of study drug.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre Challenge to 30 Days Post ChallengePopulation: MITT population included all participants who received at least one dose of study drug, Challenge stage.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=56 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=53 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool
RT-PCR Alone
|
53.6 percentage of participants
|
60.4 percentage of participants
|
|
Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool
4-Fold rise in P-particle ELISA alone; n=56,51
|
7.1 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool
Either RT-PCR or 4-fold rise in P-particle;n=56,52
|
53.6 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)Population: Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Vesikari Scoring System assesses the following symptoms: duration of diarrhea (days), maximum number of diarrheal stools/24 hours, duration of vomiting (days), maximum number of vomiting episodes/24 hours, fever and dehydration. Since the typical inpatient phase was four days in length, the duration of diarrhea scoring was modified to fit this time frame. Modified Vesikari Scale Total Score=0 to 17. Higher numbers are worse.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=15 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=17 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase
|
4.4 score on a scale
Standard Deviation 2.0
|
7.1 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)Population: Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Score 1 was based on a subset of symptoms including: elevated oral temperature, myalgia, nausea, abdominal cramps, bloating, diarrhea, and vomiting. Score 2 was based on all Score 1 symptoms plus fatigue/malaise, chills, and loss of appetite. Total Score 1=0 to 20 and Total Score 2=0 to 29. Higher numbers are worse.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=15 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=17 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase
Score 1
|
1.8 score on a scale
Standard Deviation 1.0
|
3.3 score on a scale
Standard Deviation 2.0
|
|
Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase
Score 2
|
2.7 score on a scale
Standard Deviation 1.5
|
4.5 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)Population: Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Duration of symptoms was determined by a blinded committee review of each participant's symptoms.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=15 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=17 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase
|
32.1 hours
Interval 10.4 to 60.0
|
38.0 hours
Interval 2.0 to 71.0
|
SECONDARY outcome
Timeframe: Pre Challenge to 30 Days Post ChallengePopulation: Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=56 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=53 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Pre-Challenge
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 1 (n=54,53)
|
1.9 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 2 (n=52,52)
|
38.5 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 3 (n=55,51)
|
45.5 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 4 (n=52,47)
|
44.2 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 10 (n=55,51)
|
21.8 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Day 30 (n=56,52)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Any Day 1 to 30
|
53.6 percentage of participants
|
60.4 percentage of participants
|
SECONDARY outcome
Timeframe: Pre Challenge to 30 Days Post ChallengePopulation: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=56 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=51 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30
|
7.1 percentage of participants
Interval 2.0 to 17.3
|
52.9 percentage of participants
Interval 38.5 to 67.1
|
SECONDARY outcome
Timeframe: Baseline to 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
28 days Post Dose 1 (n=63, 63)
|
65.4 ratio
Interval 47.0 to 91.0
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
28 days Post Dose 2 (n= 61, 58)
|
61.2 ratio
Interval 43.9 to 85.2
|
0.9 ratio
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
28 days Post Dose 1 (n=63, 63)
|
100.0 percentage of participants
Interval 94.3 to 100.0
|
1.6 percentage of participants
Interval 0.0 to 8.5
|
|
Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
28 days Post Dose 2 (n= 61, 58)
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
3.4 percentage of participants
Interval 0.4 to 11.9
|
SECONDARY outcome
Timeframe: Baseline, 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
Baseline (Pre-Dose 1)
|
1857.6 titer
Interval 1314.1 to 2626.0
|
1671.1 titer
Interval 1188.9 to 2348.7
|
|
Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
28 days Post Dose 1 (n=63, 63)
|
127209.7 titer
Interval 99321.5 to 162928.4
|
1577.6 titer
Interval 1105.5 to 2251.3
|
|
Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
28 days Post Dose 2 (n=61, 58)
|
120552.8 titer
Interval 98844.3 to 147029.0
|
1606.3 titer
Interval 1097.7 to 2350.6
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 1 (n=63, 63)
|
12.2 ratio
Interval 8.3 to 17.9
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 2 (n=61, 58)
|
10.4 ratio
Interval 7.5 to 14.5
|
1.1 ratio
Interval 0.9 to 1.3
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Seroresponse was defined as a 4-Fold Rise from Baseline.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 1 (n=63, 63)
|
82.5 percentage of participants
Interval 70.9 to 90.9
|
1.6 percentage of participants
Interval 0.0 to 8.5
|
|
Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 2 (n=61, 58)
|
88.5 percentage of participants
Interval 77.8 to 95.3
|
1.7 percentage of participants
Interval 0.0 to 9.2
|
SECONDARY outcome
Timeframe: Baseline, 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT
Baseline (Pre-Dose 1)
|
5120.0 titer
Interval 3754.9 to 6981.3
|
4958.8 titer
Interval 3776.8 to 6510.8
|
|
Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 1 (n=63, 63)
|
63604.8 titer
Interval 49961.2 to 80974.3
|
4845.9 titer
Interval 3640.0 to 6451.4
|
|
Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 2 (n=61, 58)
|
56303.8 titer
Interval 45918.6 to 69037.7
|
5306.9 titer
Interval 3822.1 to 7368.5
|
SECONDARY outcome
Timeframe: Baseline to 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
28 days Post Dose 1 (n=63, 63)
|
16.3 ratio
Interval 11.5 to 23.2
|
1.0 ratio
Interval 1.0 to 1.1
|
|
ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
28 days Post Dose 2 (n= 61, 58)
|
11.5 ratio
Interval 8.2 to 16.2
|
1.0 ratio
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: Baseline to 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
28 days Post Dose 1 (n=63, 63)
|
85.7 percentage of participants
Interval 74.6 to 93.3
|
0.0 percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
28 days Post Dose 2 (n= 61, 58)
|
80.3 percentage of participants
Interval 68.2 to 89.4
|
0.0 percentage of participants
Interval 0.0 to 6.2
|
SECONDARY outcome
Timeframe: Baseline, 28 days Post Dose 1 and 28 days Post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
Baseline (Pre-Dose 1)
|
4.1 titer
Interval 3.5 to 4.8
|
4.0 titer
Interval 3.5 to 4.5
|
|
ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
28 days Post Dose 1 (n=63, 63)
|
66.9 titer
Interval 46.8 to 95.7
|
4.0 titer
Interval 3.5 to 4.7
|
|
ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
28 days Post Dose 2 (n=61, 58)
|
47.5 titer
Interval 33.2 to 67.8
|
4.0 titer
Interval 3.5 to 4.7
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 1 (n=63, 63)
|
9.0 ratio
Interval 6.7 to 12.1
|
1.0 ratio
Interval 0.9 to 1.1
|
|
ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 2 (n=61, 58)
|
7.7 ratio
Interval 6.0 to 9.9
|
1.1 ratio
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Seroresponse was defined as a 4-Fold Rise from Baseline.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 1 (n=63, 63)
|
73.0 percentage of participants
Interval 60.3 to 83.4
|
3.2 percentage of participants
Interval 0.4 to 11.0
|
|
Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 2 (n=61, 58)
|
72.1 percentage of participants
Interval 59.2 to 82.9
|
1.7 percentage of participants
Interval 0.0 to 9.2
|
SECONDARY outcome
Timeframe: Baseline, 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
ELISA IgA- Anti-Norovirus GII.4 cVLP GMT
Baseline (Pre-Dose 1)
|
5.9 titer
Interval 4.8 to 7.4
|
5.8 titer
Interval 4.8 to 7.1
|
|
ELISA IgA- Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 1 (n=63, 63)
|
54.1 titer
Interval 43.3 to 67.6
|
6.1 titer
Interval 5.0 to 7.4
|
|
ELISA IgA- Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 2 (n=61, 58)
|
47.0 titer
Interval 39.1 to 56.5
|
6.2 titer
Interval 5.0 to 7.7
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline
28 days Post Dose 1 (n=63, 63)
|
25.6 ratio
Interval 19.1 to 34.3
|
1.0 ratio
Interval 0.9 to 1.1
|
|
HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline
28 days Post Dose 2 (n=61, 58)
|
31.8 ratio
Interval 25.8 to 39.1
|
1.0 ratio
Interval 0.9 to 1.1
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Seroresponse was defined as a 4-Fold Rise from Baseline
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline
28 days Post Dose 1 (n=63, 63)
|
95.2 percentage of participants
Interval 86.7 to 99.0
|
0.0 percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline
28 days Post Dose 2 (n=61, 58)
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 6.2
|
SECONDARY outcome
Timeframe: Baseline, 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT
Baseline (Pre-Dose 1)
|
17.5 titer
Interval 14.6 to 20.9
|
15.2 titer
Interval 13.2 to 17.5
|
|
HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT
28 days Post Dose 1 (n=63, 63)
|
456.2 titer
Interval 324.4 to 641.6
|
15.4 titer
Interval 13.5 to 17.6
|
|
HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT
28 days Post Dose 2 (n=61, 58)
|
573.5 titer
Interval 453.0 to 726.1
|
15.1 titer
Interval 13.1 to 17.4
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 1 (n=63, 63)
|
8.0 ratio
Interval 6.2 to 10.3
|
1.0 ratio
Interval 0.9 to 1.0
|
|
HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline
28 days Post Dose 2 (n=61, 58)
|
6.6 ratio
Interval 5.3 to 8.1
|
1.0 ratio
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: Baseline to 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Seroresponse was defined as a 4-Fold Rise from Baseline.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=63 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=63 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 1 (n=63, 63)
|
69.8 percentage of participants
Interval 57.0 to 80.8
|
0.0 percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
28 days Post Dose 2 (n=61, 58)
|
73.8 percentage of participants
Interval 60.9 to 84.2
|
1.7 percentage of participants
Interval 0.0 to 9.2
|
SECONDARY outcome
Timeframe: Baseline, 28 days post Dose 1 and 28 days post Dose 2Population: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT
Baseline (Pre-Dose 1)
|
119.2 titer
Interval 104.8 to 135.5
|
127.5 titer
Interval 109.5 to 148.5
|
|
HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 1 (n=63, 63)
|
971.5 titer
Interval 794.2 to 1188.3
|
126.4 titer
Interval 107.7 to 148.2
|
|
HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT
28 days Post Dose 2 (n=61, 58)
|
803.0 titer
Interval 679.8 to 948.7
|
136.7 titer
Interval 113.3 to 165.0
|
SECONDARY outcome
Timeframe: Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challengePopulation: MITT population included all participants who received at least one dose of study drug.
Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)
Post Dose 1
|
10.4 percentage of participants
Interval 4.3 to 20.3
|
23.1 percentage of participants
Interval 13.5 to 35.2
|
|
Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)
Post Dose 2 (n=63, 64)
|
14.3 percentage of participants
Interval 6.7 to 25.4
|
18.8 percentage of participants
Interval 10.1 to 30.5
|
|
Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)
Challenge Stage
|
39.3 percentage of participants
Interval 26.5 to 53.2
|
50.9 percentage of participants
Interval 36.8 to 64.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre Challenge to Day 30 Post ChallengePopulation: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=16 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=36 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness
|
6.3 percentage of participants
|
47.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre Challenge to Day 30 Post ChallengePopulation: Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.
Outcome measures
| Measure |
Norovirus Bivalent VLP Vaccine
n=31 Participants
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=20 Participants
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection
|
12.9 percentage of participants
|
65.0 percentage of participants
|
Adverse Events
Norovirus Bivalent VLP Vaccine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Norovirus Bivalent VLP Vaccine
n=67 participants at risk
Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
|
Placebo
n=65 participants at risk
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.0%
4/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.6%
3/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
2/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose increased
|
3.0%
2/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
2/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
2/67 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.5%
1/65 • Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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