Trial Outcomes & Findings for Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. (NCT NCT02097849)
NCT ID: NCT02097849
Last Updated: 2017-06-02
Results Overview
Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Up to Week 4 (Day 28) postvaccination
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
38
|
|
Overall Study
COMPLETED
|
33
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Baseline characteristics by cohort
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 7.77 • n=99 Participants
|
45.9 years
STANDARD_DEVIATION 6.10 • n=107 Participants
|
45.3 years
STANDARD_DEVIATION 6.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level
|
73 percentage of participants
Interval 54.0 to 87.0
|
68 percentage of participants
Interval 51.0 to 82.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level
|
61 percentage of participants
Interval 42.0 to 77.0
|
42 percentage of participants
Interval 26.0 to 59.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
|
79 percentage of participants
Interval 61.0 to 91.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
|
70 percentage of participants
Interval 51.0 to 84.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level
|
88 percentage of participants
Interval 72.0 to 97.0
|
95 percentage of participants
Interval 82.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPercentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level
|
85 percentage of participants
Interval 68.0 to 95.0
|
82 percentage of participants
Interval 66.0 to 92.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPopulation: One participant in the IFN group did not have an assessment.
Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=32 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level
|
53 percentage of participants
Interval 35.0 to 71.0
|
53 percentage of participants
Interval 36.0 to 69.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPopulation: One participant in the IFN group did not have an assessment.
Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=32 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level
|
38 percentage of participants
Interval 21.0 to 56.0
|
37 percentage of participants
Interval 22.0 to 54.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationMedian serum titer ratios from prevaccination to 4 weeks after Td vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Ratio of Serum Tetanus Level at Day 28 to Prevaccination
|
6.128 ratio
Interval 2.828 to 8.139
|
4.463 ratio
Interval 1.955 to 8.244
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationMedian serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination
|
9.667 ratio
Interval 4.537 to 18.0
|
4.741 ratio
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationMedian serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination
|
27.000 ratio
Interval 12.75 to 49.286
|
13.845 ratio
Interval 6.0 to 28.25
|
SECONDARY outcome
Timeframe: Up to Week 4 (Day 28) postvaccinationPopulation: One participant in the IFN group did not have an assessment.
Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=32 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination
|
3.300 ratio
Interval 1.0 to 11.159
|
3.408 ratio
Interval 1.0 to 8.6
|
SECONDARY outcome
Timeframe: Day 1 to Week 4Population: Participants who received at least one vaccination.
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Any Event
|
18 participants
|
16 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Moderate or Severe Event
|
9 participants
|
7 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Severe Event
|
2 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Event Related to Existing Therapy
|
3 participants
|
3 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Serious Event
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Serious Event Related to Existing Therapy
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Serious Event Related to Td Vaccine
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Serious Event Related to PPSV23 Vaccine
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Serious Event Related to MCV4 Vaccine
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs
Withdrew From Study Due to an Event
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening to Week 4Population: n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Number of Participants With Shifts From Baseline in Hematology
Hemoglobin: Shift to Low; n=28, 36
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Hemoglobin: Shift to High; n=32, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Hematocrit: Shift to Low; n=31, 37
|
2 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Hematocrit: Shift to High; n=32, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Red Blood Cell Count: Shift to Low; n=25, 32
|
1 participants
|
4 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Red Blood Cell Count: Shift to High; n=33, 37
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
White Blood Cell Count: Shift to Low; n=27, 30
|
2 participants
|
4 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
White Blood Cell Count: Shift to High; n=33, 38
|
2 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Neutrophils: Shift to Low; n=27, 34
|
3 participants
|
2 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Neutrophils: Shift to High; n=33, 37
|
2 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Basophils: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Basophils: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Monocytes: Shift to Low; n=33, 38
|
0 participants
|
2 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Monocytes: Shift to High; n=33, 38
|
2 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Lymphocytes: Shift to Low; n=33, 22
|
4 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Lymphocytes: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Eosinophils: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Eosinophils: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Platelet Count: Shift to Low; n=31, 38
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Hematology
Platelet Count: Shift to High; n=32, 37
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening to Week 4Population: n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.
Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Alanine Aminotransferase: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Alanine Aminotransferase: Shift to High; n=30, 35
|
2 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Aspartate Aminotransferase: Shift to Low; n=33, 37
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Aspartate Aminotransferase: Shift to High; n=33,36
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Total Bilirubin: Shift to Low; n=32, 37
|
0 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Total Bilirubin: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Gamma-glutamyl Transferase: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Gamma-glutamyl Transferase: Shift to High; n=33,38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Blood Urea Nitrogen: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Blood Urea Nitrogen: Shift to High; n=33, 38
|
1 participants
|
1 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Creatinine: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Creatinine: Shift to High; n=33, 37
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Sodium: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Sodium: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Potassium: Shift to Low; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Potassium: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Chloride: Shift to Low; n=33, 38
|
1 participants
|
0 participants
|
|
Number of Participants With Shifts From Baseline in Blood Chemistry
Chloride: Shift to High; n=33, 38
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening to Week 4Population: Participants who had a baseline assessment and at least one postbaseline assessment.
Temperature increase: \> 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: \> 120 beats per minute (bpm) or \> 20 bpm increase from baseline. Pulse decrease: \< 50 bpm or \> 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: \> 180 millimeters of mercury (mmHg) or \> 40 mmHg from baseline. SBP decrease: \< 90 mmHg or \> 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: \> 105 mmHg or \> 30 mmHg increase from baseline. DBP decrease: \< 50 mmHg or \> 20 mmHg decrease from baseline.
Outcome measures
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=32 Participants
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 Participants
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs
Temperature Increase
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Pulse Increase
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Pulse Decrease
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP Increase
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP Decrease
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP Increase
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP Decrease
|
0 participants
|
0 participants
|
Adverse Events
Non-Pegylated IFN Treated Plus Vaccinations
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Tecfidera Treated Plus Vaccinations
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-Pegylated IFN Treated Plus Vaccinations
n=33 participants at risk
Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
Tecfidera Treated Plus Vaccinations
n=38 participants at risk
Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
|
|---|---|---|
|
General disorders
Injection site erythema
|
12.1%
4/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
13.2%
5/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
General disorders
Injection site pain
|
21.2%
7/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
21.1%
8/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
General disorders
Injection site swelling
|
9.1%
3/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
7.9%
3/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
General disorders
Injection site warmth
|
0.00%
0/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
5.3%
2/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
General disorders
Pain
|
9.1%
3/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
2.6%
1/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
General disorders
Pyrexia
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
5.3%
2/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
0.00%
0/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
0.00%
0/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
0.00%
0/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
2.6%
1/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
0.00%
0/38 • SAEs: Screening (Within 28 Days Before Day 1) up to Week 4 (Day 28 ±3 Days) or Early Withdrawal. AEs: Day 1 up to Week 4 (Day 28 ±3 Days) or Early Withdrawal
Vaccination-emergent adverse events are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER