Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 141 for:    MPL

Norovirus Bivalent-Vaccine Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609257
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : August 15, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Prevention From Norovirus Infection
Interventions Biological: Norovirus Bivalent Vaccine
Biological: Saline Comparator
Enrollment 132
Recruitment Details Participants took part in the study at 5 investigative sites in the United States from 16 June 2012 to 18 March 2014.
Pre-assignment Details Healthy Volunteers were enrolled equally in 1 of 2 treatment groups, Norovirus Bivalent VLP Vaccine or Placebo.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description 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. Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Period Title: Overall Study
Started 67 65
Received 2 Doses 63 64
Received Challenge Product 56 53
Completed 61 57
Not Completed 6 8
Reason Not Completed
Lost to Follow-up             2             1
Voluntary Withdrawal by Subject             0             1
Non-compliance/Protocol deviation             4             6
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo Total
Hide Arm/Group Description 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. Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28. Total of all reporting groups
Overall Number of Baseline Participants 67 65 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 65 participants 132 participants
32.8  (10.2) 32.1  (9.3) 32.4  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 132 participants
Female
32
  47.8%
32
  49.2%
64
  48.5%
Male
35
  52.2%
33
  50.8%
68
  51.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 132 participants
Non-Hispanic 65 63 128
Hispanic 2 2 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 132 participants
American Indian/Alaska Native 1 0 1
Asian 4 2 6
Black/African American 37 36 73
White 25 26 51
Multi-Racial 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants 65 participants 132 participants
67 65 132
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 56 53
Measure Type: Number
Unit of Measure: percentage of participants
26.8 32.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments No multiplicity adjustment.
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1
Hide Description Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Time Frame Within 7 days post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(54.0 to 77.8)
28.1
(17.6 to 40.8)
3.Primary Outcome
Title Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2
Hide Description Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.
Time Frame Within 7 days post-dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.0
(40.9 to 66.6)
20.6
(11.5 to 32.7)
4.Primary Outcome
Title Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1
Hide Description 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.
Time Frame Within 7 days post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of particpants
36.4
(24.9 to 49.1)
32.8
(21.6 to 45.7)
5.Primary Outcome
Title Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2
Hide Description Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.
Time Frame Within 7 days post-dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of particpants
30.2
(19.2 to 43.0)
19.0
(10.2 to 30.9)
6.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination
Hide Description 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.
Time Frame 365 Days Following Dose 2 (Up to 393 days)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all participants who received at least one dose of study drug.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Measure Type: Number
Unit of Measure: percentage of participants
0 0
7.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Pre Challenge to 30 Days Post Challenge
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all participants who received at least one dose of study drug, Challenge stage.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 56 53
Measure Type: Number
Unit of Measure: percentage of participants
RT-PCR Alone 53.6 60.4
4-Fold rise in P-particle ELISA alone; n=56,51 7.1 52.9
Either RT-PCR or 4-fold rise in P-particle;n=56,52 53.6 61.5
8.Secondary Outcome
Title Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase
Hide Description 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.
Time Frame Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.4  (2.0) 7.1  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Statistically significant at p<0.05. No multiplicity adjustment.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase
Hide Description 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.
Time Frame Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
Score 1 1.8  (1.0) 3.3  (2.0)
Score 2 2.7  (1.5) 4.5  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments Score 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Statistically significant at p<0.05. No multiplicity adjustment.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments Score 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments Statistically significant at p<0.05. No multiplicity adjustment.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase
Hide Description Duration of symptoms was determined by a blinded committee review of each participant's symptoms.
Time Frame Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 15 17
Median (Full Range)
Unit of Measure: hours
32.1
(10.4 to 60.0)
38.0
(2.0 to 71.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase
Hide Description [Not Specified]
Time Frame Pre Challenge to 30 Days Post Challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 56 53
Measure Type: Number
Unit of Measure: percentage of participants
Pre-Challenge 0.0 0.0
Day 1 (n=54,53) 1.9 3.8
Day 2 (n=52,52) 38.5 30.8
Day 3 (n=55,51) 45.5 51.0
Day 4 (n=52,47) 44.2 55.3
Day 10 (n=55,51) 21.8 33.3
Day 30 (n=56,52) 0.0 0.0
Any Day 1 to 30 53.6 60.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Norovirus Bivalent VLP Vaccine, Placebo
Comments Any Day 1 to 30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments Comparison of % Positive
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30
Hide Description Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.
Time Frame Pre Challenge to 30 Days Post Challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 56 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.1
(2.0 to 17.3)
52.9
(38.5 to 67.1)
13.Secondary Outcome
Title Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
65.4
(47 to 91)
1.0
(0.9 to 1.1)
28 days Post Dose 2 (n= 61, 58)
61.2
(43.9 to 85.2)
0.9
(0.8 to 1.0)
14.Secondary Outcome
Title Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
Hide Description [Not Specified]
Time Frame Baseline, 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
100.0
(94.3 to 100.0)
1.6
(0.0 to 8.5)
28 days Post Dose 2 (n= 61, 58)
100.0
(94.1 to 100.0)
3.4
(0.4 to 11.9)
15.Secondary Outcome
Title Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
Hide Description [Not Specified]
Time Frame Baseline, 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
1857.6
(1314.1 to 2626.0)
1671.1
(1188.9 to 2348.7)
28 days Post Dose 1 (n=63, 63)
127209.7
(99321.5 to 162928.4)
1577.6
(1105.5 to 2251.3)
28 days Post Dose 2 (n=61, 58)
120552.8
(98844.3 to 147029.0)
1606.3
(1097.7 to 2350.6)
16.Secondary Outcome
Title Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
12.2
(8.3 to 17.9)
1.0
(0.9 to 1.1)
28 days Post Dose 2 (n=61, 58)
10.4
(7.5 to 14.5)
1.1
(0.9 to 1.3)
17.Secondary Outcome
Title Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
Hide Description Seroresponse was defined as a 4-Fold Rise from Baseline.
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
82.5
(70.9 to 90.9)
1.6
(0.0 to 8.5)
28 days Post Dose 2 (n=61, 58)
88.5
(77.8 to 95.3)
1.7
(0.0 to 9.2)
18.Secondary Outcome
Title Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT
Hide Description [Not Specified]
Time Frame Baseline, 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
5120.0
(3754.9 to 6981.3)
4958.8
(3776.8 to 6510.8)
28 days Post Dose 1 (n=63, 63)
63604.8
(49961.2 to 80974.3)
4845.9
(3640.0 to 6451.4)
28 days Post Dose 2 (n=61, 58)
56303.8
(45918.6 to 69037.7)
5306.9
(3822.1 to 7368.5)
19.Secondary Outcome
Title ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
16.3
(11.5 to 23.2)
1.0
(1.0 to 1.1)
28 days Post Dose 2 (n= 61, 58)
11.5
(8.2 to 16.2)
1.0
(1.0 to 1.1)
20.Secondary Outcome
Title Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
85.7
(74.6 to 93.3)
0.0
(0.0 to 5.7)
28 days Post Dose 2 (n= 61, 58)
80.3
(68.2 to 89.4)
0.0
(0.0 to 6.2)
21.Secondary Outcome
Title ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)
Hide Description [Not Specified]
Time Frame Baseline, 28 days Post Dose 1 and 28 days Post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
4.1
(3.5 to 4.8)
4.0
(3.5 to 4.5)
28 days Post Dose 1 (n=63, 63)
66.9
(46.8 to 95.7)
4.0
(3.5 to 4.7)
28 days Post Dose 2 (n=61, 58)
47.5
(33.2 to 67.8)
4.0
(3.5 to 4.7)
22.Secondary Outcome
Title ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
9.0
(6.7 to 12.1)
1.0
(0.9 to 1.1)
28 days Post Dose 2 (n=61, 58)
7.7
(6.0 to 9.9)
1.1
(0.9 to 1.2)
23.Secondary Outcome
Title Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
Hide Description Seroresponse was defined as a 4-Fold Rise from Baseline.
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
73.0
(60.3 to 83.4)
3.2
(0.4 to 11.0)
28 days Post Dose 2 (n=61, 58)
72.1
(59.2 to 82.9)
1.7
(0.0 to 9.2)
24.Secondary Outcome
Title ELISA IgA- Anti-Norovirus GII.4 cVLP GMT
Hide Description [Not Specified]
Time Frame Baseline, 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
5.9
(4.8 to 7.4)
5.8
(4.8 to 7.1)
28 days Post Dose 1 (n=63, 63)
54.1
(43.3 to 67.6)
6.1
(5.0 to 7.4)
28 days Post Dose 2 (n=61, 58)
47.0
(39.1 to 56.5)
6.2
(5.0 to 7.7)
25.Secondary Outcome
Title HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline
Hide Description HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
25.6
(19.1 to 34.3)
1.0
(0.9 to 1.1)
28 days Post Dose 2 (n=61, 58)
31.8
(25.8 to 39.1)
1.0
(0.9 to 1.1)
26.Secondary Outcome
Title Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline
Hide Description Seroresponse was defined as a 4-Fold Rise from Baseline
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
95.2
(86.7 to 99.0)
0.0
(0.0 to 5.7)
28 days Post Dose 2 (n=61, 58)
100.0
(94.1 to 100.0)
0.0
(0.0 to 6.2)
27.Secondary Outcome
Title HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT
Hide Description [Not Specified]
Time Frame Baseline, 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
17.5
(14.6 to 20.9)
15.2
(13.2 to 17.5)
28 days Post Dose 1 (n=63, 63)
456.2
(324.4 to 641.6)
15.4
(13.5 to 17.6)
28 days Post Dose 2 (n=61, 58)
573.5
(453.0 to 726.1)
15.1
(13.1 to 17.4)
28.Secondary Outcome
Title HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
28 days Post Dose 1 (n=63, 63)
8.0
(6.2 to 10.3)
1.0
(0.9 to 1.0)
28 days Post Dose 2 (n=61, 58)
6.6
(5.3 to 8.1)
1.0
(0.9 to 1.2)
29.Secondary Outcome
Title Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline
Hide Description Seroresponse was defined as a 4-Fold Rise from Baseline.
Time Frame Baseline to 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 63 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28 days Post Dose 1 (n=63, 63)
69.8
(57.0 to 80.8)
0.0
(0.0 to 5.7)
28 days Post Dose 2 (n=61, 58)
73.8
(60.9 to 84.2)
1.7
(0.0 to 9.2)
30.Secondary Outcome
Title HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT
Hide Description [Not Specified]
Time Frame Baseline, 28 days post Dose 1 and 28 days post Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline (Pre-Dose 1)
119.2
(104.8 to 135.5)
127.5
(109.5 to 148.5)
28 days Post Dose 1 (n=63, 63)
971.5
(794.2 to 1188.3)
126.4
(107.7 to 148.2)
28 days Post Dose 2 (n=61, 58)
803.0
(679.8 to 948.7)
136.7
(113.3 to 165.0)
31.Secondary Outcome
Title Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)
Hide Description Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.
Time Frame Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challenge
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all participants who received at least one dose of study drug.
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description:
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.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 67 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Post Dose 1
10.4
(4.3 to 20.3)
23.1
(13.5 to 35.2)
Post Dose 2 (n=63, 64)
14.3
(6.7 to 25.4)
18.8
(10.1 to 30.5)
Challenge Stage
39.3
(26.5 to 53.2)
50.9
(36.8 to 64.9)
32.Other Pre-specified Outcome
Title Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness
Hide Description Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.
Time Frame Pre Challenge to Day 30 Post Challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Placebo Placebo_Not Ill
Hide Arm/Group Description:
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 16 36
Measure Type: Number
Unit of Measure: percentage of participants
6.3 47.2
33.Other Pre-specified Outcome
Title Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection
Hide Description Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.
Time Frame Pre Challenge to Day 30 Post Challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Placebo Placebo_Not Infected
Hide Arm/Group Description:
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
Overall Number of Participants Analyzed 31 20
Measure Type: Number
Unit of Measure: percentage of participants
12.9 65.0
Time Frame Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
Adverse Event Reporting Description 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.
 
Arm/Group Title Norovirus Bivalent VLP Vaccine Placebo
Hide Arm/Group Description 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. Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
All-Cause Mortality
Norovirus Bivalent VLP Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Norovirus Bivalent VLP Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/65 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Norovirus Bivalent VLP Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/67 (14.93%)   7/65 (10.77%) 
Infections and infestations     
Nasopharyngitis *  4/67 (5.97%)  3/65 (4.62%) 
Upper respiratory tract infection *  1/67 (1.49%)  2/65 (3.08%) 
Investigations     
Blood glucose increased *  2/67 (2.99%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  2/67 (2.99%)  0/65 (0.00%) 
Pain in extremity *  0/67 (0.00%)  2/65 (3.08%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  2/67 (2.99%)  1/65 (1.54%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01609257     History of Changes
Other Study ID Numbers: LV03-105
U1111-1177-4095 ( Registry Identifier: WHO )
First Submitted: May 25, 2012
First Posted: May 31, 2012
Results First Submitted: December 8, 2015
Results First Posted: August 15, 2016
Last Update Posted: January 9, 2019