Trial Outcomes & Findings for Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) (NCT NCT02598089)
NCT ID: NCT02598089
Last Updated: 2019-02-15
Results Overview
Any adverse event occurring within the 30 minute post vaccination period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
30-minute post-vaccination period.
Results posted on
2019-02-15
Participant Flow
Sixty four (64) subjects were consented and 4 were not randomized, leaving 60 subjects for the study.
Participant milestones
| Measure |
Trivalent Seasonal Influenza Vaccine
0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1 \& H3N2
|
Placebo
0.5 mL of Phosphate Buffered Saline
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
Baseline characteristics by cohort
| Measure |
Trivalent Seasonal Influenza Vaccine
n=30 Participants
0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo
n=30 Participants
0.5 mL of Phosphate Buffered Saline
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
n=5 Participants
|
37.8 years
n=7 Participants
|
37.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-minute post-vaccination period.Population: The analysis was conducted for subjects who were randomized and received a study vaccination.
Any adverse event occurring within the 30 minute post vaccination period.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number of Participants With Immediate Adverse Events
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 7-day period (Days 1-7) post-vaccination.Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Pain · Mild
|
17 Participants
|
5 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Pain · Moderate
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Pain · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Pain · None
|
11 Participants
|
25 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Tenderness · Mild
|
16 Participants
|
9 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Tenderness · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Tenderness · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Tenderness · None
|
13 Participants
|
21 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Hardness · Mild
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Hardness · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Hardness · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Hardness · None
|
29 Participants
|
30 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Swelling · Mild
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Swelling · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Swelling · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Swelling · None
|
29 Participants
|
30 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Redness · Mild
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Redness · Moderate
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Redness · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Redness · None
|
30 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 7-day period (Days 1-7) post-vaccinationPopulation: The analysis was conducted for subjects who were randomized and received a study vaccination
Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Vomiting · None
|
29 Participants
|
29 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Joint aches · Mild
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Joint aches · Moderate
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Joint aches · Severe
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Joint aches · None
|
29 Participants
|
28 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Nausea · Mild
|
0 Participants
|
3 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Nausea · Moderate
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Nausea · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Nausea · None
|
30 Participants
|
27 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Headache · Mild
|
6 Participants
|
8 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Headache · Moderate
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Headache · None
|
23 Participants
|
21 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Tiredness/discomfort · Mild
|
5 Participants
|
6 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Tiredness/discomfort · Moderate
|
2 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Tiredness/discomfort · Severe
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Tiredness/discomfort · None
|
23 Participants
|
22 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Chills · Mild
|
2 Participants
|
3 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Chills · Moderate
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Chills · None
|
28 Participants
|
26 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Muscle aches · Mild
|
3 Participants
|
4 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Muscle aches · Moderate
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Muscle aches · Severe
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Muscle aches · None
|
27 Participants
|
25 Participants
|
|
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Vomiting · Mild
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 21 days post-vaccinationPopulation: The analysis was conducted for subjects who were randomized and received a study vaccination.
Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Participants With Unsolicited Adverse Events
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Over the entire study period (Day 91)Population: The analysis was conducted for subjects who were randomized and received a study vaccination
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)--related
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants With Serious Adverse Events (SAEs)
SAEs--not related
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 22Seroconversion is defined as a serum HAI titer meeting the following criteria: * pre-vaccination titer \<1:10 and a post-vaccination titer ≥ 1:40 or * pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Seroconversion rate to H1N1
|
28 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Seroconversion rate to H3N2
|
25 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Seroconversion rate to B
|
23 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 post vaccinationA seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer \>/= 1:40. The 3 influenza strains assessed were B, H1, and H3.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
H1
|
29 Participants
|
6 Participants
|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
H3
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
B
|
28 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre- (Day 1) and post-vaccination (Day 22)Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to H1 Day 1
|
10.0 Titers
Interval 6.7 to 15.0
|
10.6 Titers
Interval 7.1 to 15.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to H1 Day 22
|
371.9 Titers
Interval 245.4 to 563.6
|
10.7 Titers
Interval 7.2 to 15.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to H3 Day 1
|
39.5 Titers
Interval 22.9 to 68.4
|
35.6 Titers
Interval 21.8 to 58.3
|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to H3 Day 22
|
640 Titers
Interval 419.2 to 977.1
|
33.6 Titers
Interval 21.6 to 52.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to B Day 1
|
8.8 Titers
Interval 6.7 to 11.6
|
6.9 Titers
Interval 5.8 to 8.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
GMT to B Day 22
|
68.1 Titers
Interval 47.1 to 98.2
|
7.0 Titers
Interval 5.9 to 8.3
|
SECONDARY outcome
Timeframe: Day 22/Day1Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
GMFR Day 22/Day 1 for H1
|
37.2 fold rise
Interval 23.7 to 58.3
|
1 fold rise
Interval 0.9 to 1.0
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
GMFR Day 22/Day 1 for H3
|
16.2 fold rise
Interval 9.2 to 28.4
|
1.0 fold rise
Interval 0.9 to 1.0
|
|
Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
GMFR Day 22/Day 1 for B
|
7.7 fold rise
Interval 5.0 to 12.1
|
1.0 fold rise
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: Pre- (Day 1) and Post-vaccination (Day 22)Population: All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol deviations
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to H1 Day 1
|
8.7 Titers
Interval 6.0 to 12.5
|
10.8 Titers
Interval 7.3 to 16.1
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to H1 Day 22
|
417.4 Titers
Interval 263.0 to 662.4
|
10.5 Titers
Interval 7.2 to 15.3
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to H3 Day 1
|
38.6 Titers
Interval 22.4 to 63.8
|
40.0 Titers
Interval 23.5 to 68.1
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to H3 Day 22
|
670.3 Titers
Interval 405.9 to 1106.7
|
39.1 Titers
Interval 23.1 to 66.2
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to B Day 1
|
16.2 Titers
Interval 10.3 to 25.6
|
14.6 Titers
Interval 10.4 to 20.6
|
|
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
GMT to B Day 22
|
201.6 Titers
Interval 123.6 to 328.8
|
14.3 Titers
Interval 10.2 to 20.0
|
SECONDARY outcome
Timeframe: Pre- (Day 1) and Post-vaccination (Day 22)Population: All vaccinated subjects who have valid post-vaccination immunogenicity measures with no major protocol violations
Outcome measures
| Measure |
Vaccine Group
n=30 Participants
0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo Group
n=30 Participants
0.5 mL of phosphate buffered saline
|
|---|---|---|
|
Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
GMFR for H1
|
47.9 fold rise
Interval 29.1 to 79.0
|
1.0 fold rise
Interval 0.9 to 1.0
|
|
Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
GMFR for B
|
12.4 fold rise
Interval 6.9 to 22.3
|
1.0 fold rise
Interval 0.9 to 1.0
|
|
Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
GMFR for H3
|
17.3 fold rise
Interval 9.7 to 31.0
|
1.0 fold rise
Interval 0.9 to 1.0
|
Adverse Events
Trivalent Seasonal Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trivalent Seasonal Influenza Vaccine
n=30 participants at risk
0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, \& H3N2
|
Placebo
n=30 participants at risk
0.5 mL of Phosphate Buffered Saline
|
|---|---|---|
|
Infections and infestations
Oropharyngeal pain/sore throat
|
0.00%
0/30 • 90 days
We included AEs that occurred any time after the vaccine/placebo was administered , whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject) unless they started after 7 days post-vaccination. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity.
|
6.7%
2/30 • Number of events 2 • 90 days
We included AEs that occurred any time after the vaccine/placebo was administered , whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject) unless they started after 7 days post-vaccination. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place