Trial Outcomes & Findings for Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents (NCT NCT00387725)
NCT ID: NCT00387725
Last Updated: 2014-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
1 month after Dose 2
Results posted on
2014-11-21
Participant Flow
Participant milestones
| Measure |
Twinrix
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
45
|
45
|
|
Overall Study
COMPLETED
|
20
|
15
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Twinrix
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Parent/legal guardian request
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Baseline characteristics by cohort
| Measure |
Twinrix
n=21 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.19 years
STANDARD_DEVIATION 1.44 • n=5 Participants
|
10.69 years
STANDARD_DEVIATION 0.95 • n=7 Participants
|
10.31 years
STANDARD_DEVIATION 1.24 • n=5 Participants
|
10.31 years
STANDARD_DEVIATION 1.29 • n=4 Participants
|
10.34 years
STANDARD_DEVIATION 1.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month after Dose 2Outcome measures
| Measure |
Twinrix
n=21 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
PMB1745 (N=19, 15, 44, 42)
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
63.6 percentage of participants
Interval 47.8 to 77.6
|
83.3 percentage of participants
Interval 68.6 to 93.0
|
|
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
PMB17 (N=18, 16, 44, 42)
|
0.0 percentage of participants
Interval 0.0 to 18.5
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
52.3 percentage of participants
Interval 36.7 to 67.5
|
61.9 percentage of participants
Interval 45.6 to 76.4
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Outcome measures
| Measure |
Twinrix
n=21 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
PMB17 (N=18, 16, 41, 43)
|
0.0 percentage of participants
Interval 0.0 to 18.5
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
82.9 percentage of participants
Interval 67.9 to 92.8
|
95.3 percentage of participants
Interval 84.2 to 99.4
|
|
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
PMB1745 (N=19, 16, 41, 43)
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
70.7 percentage of participants
Interval 54.5 to 83.9
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
PRIMARY outcome
Timeframe: Dose 1 up to 1 month after Dose 3Outcome measures
| Measure |
Twinrix
n=21 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 Participants
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
|
90.5 percentage of participants
|
93.8 percentage of participants
|
93.3 percentage of participants
|
97.8 percentage of participants
|
Adverse Events
Twinrix
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Initial Formulation rLP2086 20 mcg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Initial Formulation rLP2086 60 mcg
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Initial Formulation rLP2086 200 mcg
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Twinrix
n=21 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 participants at risk
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site erythema
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site swelling
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Appendicitis
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Orchitis
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
Other adverse events
| Measure |
Twinrix
n=21 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 20 mcg
n=16 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 60 mcg
n=45 participants at risk
Given on a 0, 1-, 6- month schedule
|
Initial Formulation rLP2086 200 mcg
n=45 participants at risk
Given on a 0, 1-, 6- month schedule
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Head injury
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Sunburn
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
18.8%
3/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Venomous sting
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Investigations
Lymph node Palpable
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Ear and labyrinth disorders
Ear pain
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Eye disorders
Eye swelling
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Eye disorders
Eyelid disorder
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • Dose 1 up to 1 month after Dose 3
|
18.8%
3/16 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
15.6%
7/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
17.8%
8/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Chills
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Fatigue
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Gait disturbance
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Influenza like illness
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site erythema
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site movement impairment
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Injection site pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Malaise
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Pyrexia
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Immune system disorders
Seasonal allergy
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
18.8%
3/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Enterobiasis
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Gastroenteritis
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Hordeolum
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Impetigo
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Infected bites
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Influenza
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
13.3%
6/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Nail infection
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Otitis externa
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Otitis media
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Rhinitis
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Tonsillitis
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Upper respiratory tract infection
|
52.4%
11/21 • Dose 1 up to 1 month after Dose 3
|
31.2%
5/16 • Dose 1 up to 1 month after Dose 3
|
55.6%
25/45 • Dose 1 up to 1 month after Dose 3
|
51.1%
23/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Viraemia
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Viral infection
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
13.3%
6/45 • Dose 1 up to 1 month after Dose 3
|
|
Infections and infestations
Viral upper repiratory tract infection
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Headache
|
57.1%
12/21 • Dose 1 up to 1 month after Dose 3
|
25.0%
4/16 • Dose 1 up to 1 month after Dose 3
|
40.0%
18/45 • Dose 1 up to 1 month after Dose 3
|
51.1%
23/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Somnolence
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
8.9%
4/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
23.8%
5/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
22.2%
10/45 • Dose 1 up to 1 month after Dose 3
|
11.1%
5/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
12.5%
2/16 • Dose 1 up to 1 month after Dose 3
|
6.7%
3/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.5%
2/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Scab
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
2.2%
1/45 • Dose 1 up to 1 month after Dose 3
|
|
Vascular disorders
Pallor
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Dose 1 up to 1 month after Dose 3
|
6.2%
1/16 • Dose 1 up to 1 month after Dose 3
|
4.4%
2/45 • Dose 1 up to 1 month after Dose 3
|
0.00%
0/45 • Dose 1 up to 1 month after Dose 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER