Trial Outcomes & Findings for Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine. (NCT NCT00774995)
NCT ID: NCT00774995
Last Updated: 2016-11-02
Results Overview
Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations \>= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
One month after the hepatitis B vaccine challenge dose.
Results posted on
2016-11-02
Participant Flow
Participant milestones
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
8
|
16
|
|
Overall Study
COMPLETED
|
9
|
16
|
7
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Baseline characteristics by cohort
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=9 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.3 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
19.6 Years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
19.8 Years
STANDARD_DEVIATION 0.46 • n=5 Participants
|
19.5 Years
STANDARD_DEVIATION 0.52 • n=4 Participants
|
19.5 Years
STANDARD_DEVIATION 0.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations \>= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=6 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=15 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
|
8 Subjects
|
13 Subjects
|
6 Subjects
|
14 Subjects
|
PRIMARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations \>= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=7 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=5 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=12 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).
|
7 Subjects
|
11 Subjects
|
5 Subjects
|
12 Subjects
|
SECONDARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=6 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=15 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.
≥ 3.3 mIU/mL
|
8 Subjects
|
14 Subjects
|
6 Subjects
|
15 Subjects
|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.
≥ 10 mIU/mL
|
8 Subjects
|
13 Subjects
|
6 Subjects
|
15 Subjects
|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.
≥ 100 mIU/mL
|
8 Subjects
|
8 Subjects
|
6 Subjects
|
12 Subjects
|
SECONDARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=7 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=6 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=15 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.
≥ 6.2 mIU/mL
|
7 Subjects
|
12 Subjects
|
6 Subjects
|
15 Subjects
|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.
≥ 10 mIU/mL
|
7 Subjects
|
12 Subjects
|
6 Subjects
|
15 Subjects
|
|
Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.
≥ 100 mIU/mL
|
7 Subjects
|
7 Subjects
|
6 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=6 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=15 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.
|
2852.1 mIU/mL
Interval 1189.7 to 6837.3
|
163.8 mIU/mL
Interval 42.8 to 625.9
|
1420.2 mIU/mL
Interval 331.1 to 6090.9
|
515.5 mIU/mL
Interval 173.7 to 1530.3
|
SECONDARY outcome
Timeframe: One month after the hepatitis B vaccine challenge dose.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=7 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=14 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=6 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=15 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.
|
1831.6 mIU/mL
Interval 582.5 to 5758.9
|
165.6 mIU/mL
Interval 45.5 to 602.4
|
1335.2 mIU/mL
Interval 263.0 to 6779.0
|
454.1 mIU/mL
Interval 165.0 to 1250.0
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period after the hepatitis B vaccine challenge dose.Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=9 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.
Subjects with any symptoms
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.
Subjects with grade 3 symptoms
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.
Subjects with related symptoms
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period after the challenge dose (1 month).SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=9 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=8 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=16 Participants
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
Number of Subjects That Experienced Serious Adverse Events (SAEs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Engerix(3-dose)+HBIg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix(4-dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix(3-dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)
n=9 participants at risk
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)+HBIg
n=16 participants at risk
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(4-dose)
n=8 participants at risk
Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
Engerix(3-dose)
n=16 participants at risk
Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
11.1%
1/9 • Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
|
0.00%
0/16 • Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
|
0.00%
0/8 • Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
|
0.00%
0/16 • Serious adverse events: During the entire study period i.e. from Day 0 to Month 1; Unsolicited adverse events: During the 31 days (Day 0 to Day 30) post challenge dose.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER