Trial Outcomes & Findings for Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents (NCT NCT02387294)
NCT ID: NCT02387294
Last Updated: 2021-03-11
Results Overview
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
21-28 days after vaccination
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
Age Group 1: Children (3-11 Years)
Intervention: Vaccination with Fluval AB Novo
Dosage: half of the single dose
|
Age Group 2: Adolescents
Intervention: Vaccination with Fluval AB Novo
Dosage: single dose
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
Baseline characteristics by cohort
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents (12-18 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.93 years
STANDARD_DEVIATION 2.65 • n=5 Participants
|
14.38 years
STANDARD_DEVIATION 1.54 • n=7 Participants
|
11.16 years
STANDARD_DEVIATION 3.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Increase in Geometric Mean Titre Ratio, A/H1N1 Strain
|
4.337 Ratio of Day 0 and Day 21-28 titres
Interval 3.432 to 5.48
|
4.702 Ratio of Day 0 and Day 21-28 titres
Interval 3.595 to 6.151
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Increase in Geometric Mean Titre Ratio, A/H3N2 Strain
|
4.982 Ratio of Day 0 and Day 21-28 antihaemagg
Interval 3.847 to 6.451
|
5.993 Ratio of Day 0 and Day 21-28 antihaemagg
Interval 4.207 to 8.539
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Increase in Geometric Mean Titre Ratio, B Strain
|
4.262 Ratio of Day 0 and Day 21-28 titres
Interval 3.383 to 5.37
|
4.757 Ratio of Day 0 and Day 21-28 titres
Interval 3.762 to 6.014
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroconversion, A/H1N1 Strain
|
61.67 percentage of subjects seroconverted
|
66.67 percentage of subjects seroconverted
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroconversion, A/H3N2 Strain
|
58.33 percentage of subjects seroconverted
|
61.67 percentage of subjects seroconverted
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroconversion, B Strain
|
66.67 percentage of subjects seroconverted
|
70.00 percentage of subjects seroconverted
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroprotected Requirement: \> 70 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroprotection, A/H1N1 Strain
|
91.67 percentage of subjects seroprotected
|
96.67 percentage of subjects seroprotected
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroprotected Requirement: \> 70 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroprotection, A/H3N2 Strain
|
95.00 percentage of subjects seroprotected
|
95.00 percentage of subjects seroprotected
|
PRIMARY outcome
Timeframe: 21-28 days after vaccinationPopulation: PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)
Proportion of subjects seroprotected Requirement: \> 70 %
Outcome measures
| Measure |
Age Group 1: Children (3-11 Years)
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents
n=60 Participants
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Seroprotection, B Strain
|
80.00 percentage of subjects seroprotected
|
86.67 percentage of subjects seroprotected
|
Adverse Events
Age Group 1: Children (3-11 Years)
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Age Group 2: Adolescents (12-18 Years)
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age Group 1: Children (3-11 Years)
n=60 participants at risk
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.
|
Age Group 2: Adolescents (12-18 Years)
n=60 participants at risk
Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.
|
|---|---|---|
|
Infections and infestations
pharyngitis
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Nervous system disorders
headache
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
8.3%
5/60 • Number of events 5 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Infections and infestations
helminthic infection
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
vaccination site pain
|
35.0%
21/60 • Number of events 21 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
28.3%
17/60 • Number of events 17 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
vaccination site erythema
|
11.7%
7/60 • Number of events 7 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
vaccination site swelling
|
11.7%
7/60 • Number of events 7 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.7%
4/60 • Number of events 4 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
13.3%
8/60 • Number of events 8 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
malaise
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
11.7%
7/60 • Number of events 7 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
vaccination site induration
|
5.0%
3/60 • Number of events 3 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
8.3%
5/60 • Number of events 5 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
vaccination site haematoma
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
chills
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Infections and infestations
cystitis
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
General disorders
pyrexia
|
5.0%
3/60 • Number of events 3 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
5.0%
3/60 • Number of events 3 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Gastrointestinal disorders
vomiting
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Nervous system disorders
syncope
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
1.7%
1/60 • Number of events 1 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
3.3%
2/60 • Number of events 2 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
0.00%
0/60 • 21-28 days after vaccination
Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor in the frames of the general confidentiality agreement is that the PI cannot release any information concenning the study without the prior consent of the sponsor. To further specification is provided.
- Publication restrictions are in place
Restriction type: OTHER