Trial Outcomes & Findings for A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis (NCT NCT02545868)
NCT ID: NCT02545868
Last Updated: 2024-03-26
Results Overview
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
8 weeks after TT vaccine
Results posted on
2024-03-26
Participant Flow
The study recruited participants with relapsing forms of multiple sclerosis in 2 countries from 27 October 2015 to 14 February 2017.
A total of 122 participants were screened of which 102 participants were randomized.
Participant milestones
| Measure |
Group A1
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group A2
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
34
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
34
|
34
|
Reasons for withdrawal
| Measure |
Group A1
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group A2
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
1
|
|
Overall Study
Non-compliance
|
1
|
1
|
1
|
|
Overall Study
Treatment change
|
21
|
19
|
22
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
9
|
Baseline Characteristics
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Group A1
n=33 Participants
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group A2
n=35 Participants
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after TT vaccinePopulation: OC population included all randomized participants who completed the ISP.
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
|
23.9 percentage of participants
|
54.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after TT vaccinePopulation: OC population included all randomized participants who completed the ISP.
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
|
24.2 percentage of participants
|
60.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after TT vaccinePopulation: OC population included all randomized participants who completed the ISP.
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
|
40.9 percentage of participants
|
87.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to and at 4 and 8 weeks after TT vaccinePopulation: OC population included all randomized participants who completed the ISP.
Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Mean Levels of Anti-Tetanus Antibody
Pre-Vaccination
|
1.680 IU/mL
Interval 1.275 to 2.214
|
2.147 IU/mL
Interval 1.612 to 2.859
|
—
|
|
Mean Levels of Anti-Tetanus Antibody
4 weeks after TT vaccine
|
4.132 IU/mL
Interval 3.373 to 5.061
|
12.157 IU/mL
Interval 9.498 to 15.56
|
—
|
|
Mean Levels of Anti-Tetanus Antibody
8 weeks after TT vaccine
|
3.743 IU/mL
Interval 3.048 to 4.596
|
9.812 IU/mL
Interval 7.842 to 12.277
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administrationPopulation: OC population included all randomized participants who completed the ISP.
Anti-KLH antibody levels were assessed by ELISA.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Immediately prior to first KLH administration
|
274 titer units
Interval 213.0 to 354.0
|
235 titer units
Interval 180.0 to 308.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
4 weeks after first KLH administration
|
384 titer units
Interval 285.0 to 517.0
|
1086 titer units
Interval 769.0 to 1534.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
8 weeks after first KLH administration
|
2916 titer units
Interval 1998.0 to 4253.0
|
17737 titer units
Interval 12441.0 to 25287.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
12 weeks after first KLH administration
|
5298 titer units
Interval 3794.0 to 7397.0
|
60270 titer units
Interval 43557.0 to 83396.0
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administrationPopulation: OC population included all randomized participants who completed the ISP.
Anti-KLH antibody levels were assessed by ELISA.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Mean Levels of Anti-KLH Antibody: Ig M
Immediately prior to first KLH administration
|
100 titer units
Interval 82.0 to 122.0
|
130 titer units
Interval 101.0 to 168.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Ig M
4 weeks after first KLH administration
|
124 titer units
Interval 100.0 to 155.0
|
217 titer units
Interval 158.0 to 298.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Ig M
8 weeks after first KLH administration
|
361 titer units
Interval 273.0 to 478.0
|
1086 titer units
Interval 797.0 to 1481.0
|
—
|
|
Mean Levels of Anti-KLH Antibody: Ig M
12 weeks after first KLH administration
|
372 titer units
Interval 286.0 to 483.0
|
1883 titer units
Interval 1405.0 to 2524.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after 23-PPVPopulation: OC population included all randomized participants who completed the ISP.
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (\>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 8
|
64.2 percentage of participants
|
97.1 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 9N
|
41.8 percentage of participants
|
88.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 1
|
49.3 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 2
|
53.7 percentage of participants
|
97.1 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 3
|
34.3 percentage of participants
|
82.4 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 4
|
28.4 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 5
|
40.3 percentage of participants
|
94.1 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 6B
|
47.8 percentage of participants
|
85.3 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 7F
|
32.8 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 9V
|
50.7 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 10A
|
28.4 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 11A
|
29.9 percentage of participants
|
82.4 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 12F
|
20.9 percentage of participants
|
76.5 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 14
|
62.7 percentage of participants
|
88.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 15B
|
40.3 percentage of participants
|
88.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 17F
|
31.3 percentage of participants
|
88.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 18C
|
38.8 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 19A
|
41.8 percentage of participants
|
88.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 19F
|
32.8 percentage of participants
|
85.3 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 20
|
20.9 percentage of participants
|
82.4 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 22F
|
34.3 percentage of participants
|
91.2 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 23F
|
43.3 percentage of participants
|
76.5 percentage of participants
|
—
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Serotype 33F
|
46.3 percentage of participants
|
94.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after 23-PPVPopulation: OC population included all randomized participants who completed the ISP.
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
|
86.6 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after 23-PPVPopulation: OC population included all randomized participants who completed the ISP.
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
|
37.3 percentage of participants
|
97.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to and 4 weeks after 23-PPVPopulation: OC population included all randomized participants who completed the ISP.
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 1
|
0.94 mcg/mL
Interval 0.71 to 1.26
|
1.02 mcg/mL
Interval 0.71 to 1.46
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 2
|
1.12 mcg/mL
Interval 0.85 to 1.47
|
1.25 mcg/mL
Interval 0.93 to 1.69
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 15B
|
0.82 mcg/mL
Interval 0.68 to 1.0
|
1.18 mcg/mL
Interval 0.73 to 1.92
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 17F
|
0.89 mcg/mL
Interval 0.7 to 1.14
|
1.05 mcg/mL
Interval 0.75 to 1.48
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 6B
|
1.47 mcg/mL
Interval 1.03 to 2.1
|
3.94 mcg/mL
Interval 2.12 to 7.33
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 7F
|
1.36 mcg/mL
Interval 1.06 to 1.74
|
4.92 mcg/mL
Interval 2.99 to 8.09
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 19A
|
1.58 mcg/mL
Interval 1.14 to 2.2
|
2.09 mcg/mL
Interval 1.26 to 3.46
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 23F
|
0.72 mcg/mL
Interval 0.56 to 0.93
|
0.96 mcg/mL
Interval 0.66 to 1.41
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 33F
|
0.96 mcg/mL
Interval 0.76 to 1.22
|
0.67 mcg/mL
Interval 0.52 to 0.85
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 1
|
1.31 mcg/mL
Interval 1.03 to 1.67
|
11.58 mcg/mL
Interval 7.72 to 17.38
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 2
|
1.79 mcg/mL
Interval 1.38 to 2.3
|
9.41 mcg/mL
Interval 6.8 to 13.01
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 3
|
1.57 mcg/mL
Interval 1.2 to 2.06
|
2.76 mcg/mL
Interval 1.72 to 4.42
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 4
|
1.54 mcg/mL
Interval 1.01 to 2.35
|
2.02 mcg/mL
Interval 1.32 to 3.08
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 5
|
1.25 mcg/mL
Interval 0.97 to 1.62
|
10.16 mcg/mL
Interval 5.69 to 18.15
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 19F
|
1.09 mcg/mL
Interval 0.89 to 1.35
|
1.16 mcg/mL
Interval 0.8 to 1.67
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 20
|
1.71 mcg/mL
Interval 1.27 to 2.29
|
1.29 mcg/mL
Interval 0.89 to 1.87
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 22F
|
0.73 mcg/mL
Interval 0.55 to 0.97
|
0.82 mcg/mL
Interval 0.55 to 1.2
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 3
|
1.10 mcg/mL
Interval 0.81 to 1.5
|
0.95 mcg/mL
Interval 0.66 to 1.36
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 4
|
0.68 mcg/mL
Interval 0.41 to 1.13
|
0.59 mcg/mL
Interval 0.4 to 0.88
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 5
|
0.96 mcg/mL
Interval 0.72 to 1.27
|
1.31 mcg/mL
Interval 0.91 to 1.89
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 6B
|
0.84 mcg/mL
Interval 0.63 to 1.11
|
0.92 mcg/mL
Interval 0.6 to 1.39
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 7F
|
0.89 mcg/mL
Interval 0.72 to 1.1
|
0.94 mcg/mL
Interval 0.7 to 1.27
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 8
|
0.92 mcg/mL
Interval 0.68 to 1.23
|
0.91 mcg/mL
Interval 0.59 to 1.38
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 9N
|
0.74 mcg/mL
Interval 0.55 to 1.01
|
1.06 mcg/mL
Interval 0.68 to 1.64
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 9V
|
0.79 mcg/mL
Interval 0.55 to 1.13
|
0.74 mcg/mL
Interval 0.5 to 1.11
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 10A
|
0.88 mcg/mL
Interval 0.66 to 1.17
|
0.96 mcg/mL
Interval 0.73 to 1.26
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 11F
|
1.09 mcg/mL
Interval 0.81 to 1.45
|
1.03 mcg/mL
Interval 0.69 to 1.52
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 12F
|
0.79 mcg/mL
Interval 0.46 to 1.36
|
0.54 mcg/mL
Interval 0.35 to 0.83
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 14
|
1.33 mcg/mL
Interval 0.97 to 1.84
|
1.09 mcg/mL
Interval 0.71 to 1.68
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 18C
|
1.08 mcg/mL
Interval 0.83 to 1.41
|
1.14 mcg/mL
Interval 0.79 to 1.64
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 8
|
1.78 mcg/mL
Interval 1.35 to 2.35
|
9.04 mcg/mL
Interval 6.42 to 12.73
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 9N
|
1.21 mcg/mL
Interval 0.89 to 1.65
|
3.26 mcg/mL
Interval 2.02 to 5.28
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 9V
|
0.94 mcg/mL
Interval 0.71 to 1.24
|
3.84 mcg/mL
Interval 2.37 to 6.21
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 10A
|
1.14 mcg/mL
Interval 0.84 to 1.55
|
5.20 mcg/mL
Interval 3.27 to 8.28
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 11F
|
1.34 mcg/mL
Interval 1.03 to 1.74
|
4.74 mcg/mL
Interval 3.17 to 7.09
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 12F
|
1.13 mcg/mL
Interval 0.68 to 1.87
|
1.82 mcg/mL
Interval 1.11 to 2.99
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 14
|
3.22 mcg/mL
Interval 2.29 to 4.54
|
12.51 mcg/mL
Interval 7.5 to 20.86
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 15B
|
1.57 mcg/mL
Interval 1.22 to 2.03
|
5.60 mcg/mL
Interval 3.2 to 9.8
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 17F
|
1.41 mcg/mL
Interval 1.09 to 1.84
|
5.33 mcg/mL
Interval 3.63 to 7.82
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 18C
|
1.55 mcg/mL
Interval 1.18 to 2.03
|
7.35 mcg/mL
Interval 4.39 to 12.31
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 19A
|
2.47 mcg/mL
Interval 1.71 to 3.55
|
8.96 mcg/mL
Interval 5.43 to 14.8
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 19F
|
1.57 mcg/mL
Interval 1.26 to 1.95
|
5.09 mcg/mL
Interval 3.25 to 7.97
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 20
|
2.03 mcg/mL
Interval 1.52 to 2.71
|
3.74 mcg/mL
Interval 2.39 to 5.86
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 22F
|
1.10 mcg/mL
Interval 0.85 to 1.42
|
4.51 mcg/mL
Interval 2.93 to 6.95
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 23F
|
1.14 mcg/mL
Interval 0.9 to 1.46
|
2.90 mcg/mL
Interval 1.81 to 4.66
|
—
|
|
Mean Levels of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 33F
|
1.44 mcg/mL
Interval 1.12 to 1.85
|
5.11 mcg/mL
Interval 3.25 to 8.05
|
—
|
SECONDARY outcome
Timeframe: 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCVPopulation: OC population included all randomized participants who completed the ISP.
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Outcome measures
| Measure |
Group A (A1 + A2)
n=33 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=35 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 10A
|
29.0 percentage of participants
|
29.4 percentage of participants
|
91.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 11A
|
32.3 percentage of participants
|
44.1 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 12F
|
22.6 percentage of participants
|
20.6 percentage of participants
|
79.4 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 14
|
64.5 percentage of participants
|
67.6 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 15B
|
35.5 percentage of participants
|
38.2 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 17F
|
41.9 percentage of participants
|
44.1 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 18C
|
51.6 percentage of participants
|
32.4 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 19A
|
58.1 percentage of participants
|
35.3 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 19F
|
41.9 percentage of participants
|
29.4 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 20
|
25.8 percentage of participants
|
14.7 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 22F
|
38.7 percentage of participants
|
23.5 percentage of participants
|
91.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 23F
|
48.4 percentage of participants
|
29.4 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 33F
|
45.2 percentage of participants
|
44.1 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 1
|
54.8 percentage of participants
|
38.2 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 2
|
54.8 percentage of participants
|
44.1 percentage of participants
|
97.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 3
|
35.5 percentage of participants
|
29.4 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 4
|
32.3 percentage of participants
|
23.5 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 5
|
38.7 percentage of participants
|
44.1 percentage of participants
|
97.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 6B
|
48.4 percentage of participants
|
44.1 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 7F
|
51.6 percentage of participants
|
35.3 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 8
|
54.8 percentage of participants
|
67.6 percentage of participants
|
97.1 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 9N
|
45.2 percentage of participants
|
47.1 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Serotype 9V
|
51.6 percentage of participants
|
50.0 percentage of participants
|
88.2 percentage of participants
|
SECONDARY outcome
Timeframe: Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPVPopulation: OC population included all randomized participants who completed the ISP.
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Outcome measures
| Measure |
Group A (A1 + A2)
n=33 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=35 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 14
|
0.98 mcg/mL
Interval 0.68 to 1.42
|
1.67 mcg/mL
Interval 1.04 to 2.69
|
1.09 mcg/mL
Interval 0.71 to 1.68
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 15B
|
0.68 mcg/mL
Interval 0.5 to 0.91
|
0.96 mcg/mL
Interval 0.76 to 1.23
|
1.18 mcg/mL
Interval 0.73 to 1.92
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 22F
|
0.58 mcg/mL
Interval 0.43 to 0.78
|
0.98 mcg/mL
Interval 0.6 to 1.59
|
0.82 mcg/mL
Interval 0.55 to 1.2
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 19A
|
1.24 mcg/mL
Interval 0.88 to 1.74
|
1.99 mcg/mL
Interval 1.15 to 3.43
|
2.09 mcg/mL
Interval 1.26 to 3.46
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 23F
|
0.68 mcg/mL
Interval 0.51 to 0.91
|
0.77 mcg/mL
Interval 0.5 to 1.2
|
0.96 mcg/mL
Interval 0.66 to 1.41
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 33F
|
0.87 mcg/mL
Interval 0.62 to 1.22
|
1.05 mcg/mL
Interval 0.75 to 1.46
|
0.67 mcg/mL
Interval 0.52 to 0.85
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 1
|
1.16 mcg/mL
Interval 0.83 to 1.62
|
1.46 mcg/mL
Interval 1.04 to 2.06
|
11.58 mcg/mL
Interval 7.72 to 17.38
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 19F
|
1.06 mcg/mL
Interval 0.8 to 1.41
|
1.13 mcg/mL
Interval 0.83 to 1.53
|
1.16 mcg/mL
Interval 0.8 to 1.67
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 20
|
1.38 mcg/mL
Interval 0.93 to 2.06
|
2.13 mcg/mL
Interval 1.39 to 3.25
|
1.29 mcg/mL
Interval 0.89 to 1.87
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 1
|
0.84 mcg/mL
Interval 0.58 to 1.23
|
1.05 mcg/mL
Interval 0.68 to 1.62
|
1.02 mcg/mL
Interval 0.71 to 1.46
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 2
|
0.98 mcg/mL
Interval 0.63 to 1.52
|
1.27 mcg/mL
Interval 0.9 to 1.78
|
1.25 mcg/mL
Interval 0.93 to 1.69
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 3
|
0.93 mcg/mL
Interval 0.7 to 1.23
|
1.35 mcg/mL
Interval 0.75 to 2.42
|
0.95 mcg/mL
Interval 0.66 to 1.36
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 4
|
0.37 mcg/mL
Interval 0.29 to 0.47
|
0.88 mcg/mL
Interval 0.46 to 1.66
|
0.59 mcg/mL
Interval 0.4 to 0.88
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 5
|
0.77 mcg/mL
Interval 0.57 to 1.05
|
1.22 mcg/mL
Interval 0.76 to 1.97
|
1.31 mcg/mL
Interval 0.91 to 1.89
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 6B
|
0.64 mcg/mL
Interval 0.46 to 0.88
|
1.08 mcg/mL
Interval 0.7 to 1.68
|
0.92 mcg/mL
Interval 0.6 to 1.39
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 7F
|
1.04 mcg/mL
Interval 0.77 to 1.4
|
0.76 mcg/mL
Interval 0.57 to 1.0
|
0.94 mcg/mL
Interval 0.7 to 1.27
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 8
|
0.89 mcg/mL
Interval 0.62 to 1.27
|
0.96 mcg/mL
Interval 0.58 to 1.57
|
0.91 mcg/mL
Interval 0.59 to 1.38
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 9N
|
0.59 mcg/mL
Interval 0.4 to 0.86
|
0.98 mcg/mL
Interval 0.62 to 1.54
|
1.06 mcg/mL
Interval 0.68 to 1.64
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 9V
|
0.51 mcg/mL
Interval 0.4 to 0.65
|
1.09 mcg/mL
Interval 0.63 to 1.9
|
0.74 mcg/mL
Interval 0.5 to 1.11
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 10A
|
0.73 mcg/mL
Interval 0.52 to 1.03
|
1.01 mcg/mL
Interval 0.67 to 1.53
|
0.96 mcg/mL
Interval 0.73 to 1.26
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 11F
|
1.09 mcg/mL
Interval 0.75 to 1.58
|
1.08 mcg/mL
Interval 0.69 to 1.71
|
1.03 mcg/mL
Interval 0.69 to 1.52
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 12F
|
0.67 mcg/mL
Interval 0.49 to 0.93
|
0.89 mcg/mL
Interval 0.35 to 2.24
|
0.54 mcg/mL
Interval 0.35 to 0.83
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 17F
|
0.84 mcg/mL
Interval 0.58 to 1.22
|
0.94 mcg/mL
Interval 0.68 to 1.3
|
1.05 mcg/mL
Interval 0.75 to 1.48
|
|
Mean Level of Anti-Pneumococcal Antibody
Immediately prior to 23-PPV: Serotype : 18C
|
1.11 mcg/mL
Interval 0.73 to 1.7
|
1.04 mcg/mL
Interval 0.75 to 1.46
|
1.14 mcg/mL
Interval 0.79 to 1.64
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 2
|
1.78 mcg/mL
Interval 1.23 to 2.57
|
1.79 mcg/mL
Interval 1.26 to 2.56
|
9.41 mcg/mL
Interval 6.8 to 13.01
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 3
|
1.58 mcg/mL
Interval 1.12 to 2.23
|
1.56 mcg/mL
Interval 1.03 to 2.38
|
2.76 mcg/mL
Interval 1.72 to 4.42
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 4
|
1.15 mcg/mL
Interval 0.59 to 2.24
|
1.90 mcg/mL
Interval 1.11 to 3.23
|
2.02 mcg/mL
Interval 1.32 to 3.08
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 5
|
1.09 mcg/mL
Interval 0.78 to 1.51
|
1.44 mcg/mL
Interval 0.97 to 2.13
|
10.16 mcg/mL
Interval 5.69 to 18.15
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 6B
|
1.28 mcg/mL
Interval 0.78 to 2.1
|
1.69 mcg/mL
Interval 1.02 to 2.81
|
3.94 mcg/mL
Interval 2.12 to 7.33
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 7F
|
1.73 mcg/mL
Interval 1.17 to 2.56
|
1.10 mcg/mL
Interval 0.82 to 1.47
|
4.92 mcg/mL
Interval 2.99 to 8.09
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 8
|
1.59 mcg/mL
Interval 1.1 to 2.29
|
1.97 mcg/mL
Interval 1.3 to 2.99
|
9.04 mcg/mL
Interval 6.42 to 12.73
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 9N
|
1.08 mcg/mL
Interval 0.71 to 1.63
|
1.35 mcg/mL
Interval 0.86 to 2.12
|
3.26 mcg/mL
Interval 2.02 to 5.28
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 9V
|
0.68 mcg/mL
Interval 0.5 to 0.93
|
1.21 mcg/mL
Interval 0.8 to 1.82
|
3.84 mcg/mL
Interval 2.37 to 6.21
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 10A
|
0.84 mcg/mL
Interval 0.56 to 1.25
|
1.49 mcg/mL
Interval 0.95 to 2.32
|
5.20 mcg/mL
Interval 3.27 to 8.28
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 11F
|
1.43 mcg/mL
Interval 1.02 to 2.03
|
1.27 mcg/mL
Interval 0.86 to 1.87
|
4.74 mcg/mL
Interval 3.17 to 7.09
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 12F
|
0.71 mcg/mL
Interval 0.4 to 1.25
|
1.66 mcg/mL
Interval 0.78 to 3.52
|
1.82 mcg/mL
Interval 1.11 to 2.99
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 14
|
2.02 mcg/mL
Interval 1.32 to 3.09
|
4.83 mcg/mL
Interval 2.97 to 7.86
|
12.51 mcg/mL
Interval 7.5 to 20.86
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 15B
|
1.24 mcg/mL
Interval 0.81 to 1.92
|
1.91 mcg/mL
Interval 1.43 to 2.55
|
5.60 mcg/mL
Interval 3.2 to 9.8
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 17F
|
1.51 mcg/mL
Interval 0.98 to 2.32
|
1.35 mcg/mL
Interval 0.97 to 1.89
|
5.33 mcg/mL
Interval 3.63 to 7.82
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 18C
|
2.05 mcg/mL
Interval 1.37 to 3.08
|
1.19 mcg/mL
Interval 0.84 to 1.67
|
7.35 mcg/mL
Interval 4.39 to 12.31
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 19A
|
2.04 mcg/mL
Interval 1.35 to 3.07
|
2.95 mcg/mL
Interval 1.64 to 5.33
|
8.96 mcg/mL
Interval 5.43 to 14.8
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 19F
|
1.56 mcg/mL
Interval 1.2 to 2.03
|
1.58 mcg/mL
Interval 1.11 to 2.25
|
5.09 mcg/mL
Interval 3.25 to 7.97
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 20
|
1.63 mcg/mL
Interval 1.14 to 2.33
|
2.50 mcg/mL
Interval 1.61 to 3.87
|
3.74 mcg/mL
Interval 2.39 to 5.86
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 22F
|
1.06 mcg/mL
Interval 0.71 to 1.58
|
1.14 mcg/mL
Interval 0.83 to 1.57
|
4.51 mcg/mL
Interval 2.93 to 6.95
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 23F
|
1.11 mcg/mL
Interval 0.77 to 1.6
|
1.18 mcg/mL
Interval 0.86 to 1.62
|
2.90 mcg/mL
Interval 1.81 to 4.66
|
|
Mean Level of Anti-Pneumococcal Antibody
4 weeks after 23-PPV: Serotype : 33F
|
1.14 mcg/mL
Interval 0.82 to 1.58
|
1.82 mcg/mL
Interval 1.27 to 2.62
|
5.11 mcg/mL
Interval 3.25 to 8.05
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 1
|
1.32 mcg/mL
Interval 0.92 to 1.91
|
1.34 mcg/mL
Interval 0.96 to 1.86
|
11.38 mcg/mL
Interval 7.66 to 16.92
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 2
|
1.86 mcg/mL
Interval 1.16 to 2.99
|
1.67 mcg/mL
Interval 1.19 to 2.36
|
10.07 mcg/mL
Interval 7.33 to 13.83
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 3
|
1.68 mcg/mL
Interval 1.13 to 2.51
|
1.33 mcg/mL
Interval 0.89 to 2.0
|
2.99 mcg/mL
Interval 1.89 to 4.73
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 4
|
1.36 mcg/mL
Interval 0.64 to 2.89
|
1.84 mcg/mL
Interval 1.07 to 3.16
|
1.96 mcg/mL
Interval 1.3 to 2.96
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 5
|
1.18 mcg/mL
Interval 0.85 to 1.64
|
1.21 mcg/mL
Interval 0.83 to 1.74
|
9.17 mcg/mL
Interval 5.06 to 16.6
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 6B
|
1.72 mcg/mL
Interval 0.98 to 3.01
|
1.94 mcg/mL
Interval 1.18 to 3.19
|
4.85 mcg/mL
Interval 2.58 to 9.1
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 7F
|
1.73 mcg/mL
Interval 1.23 to 2.43
|
1.07 mcg/mL
Interval 0.78 to 1.46
|
4.95 mcg/mL
Interval 3.02 to 8.1
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 8
|
1.83 mcg/mL
Interval 1.24 to 2.71
|
1.80 mcg/mL
Interval 1.22 to 2.65
|
8.57 mcg/mL
Interval 6.03 to 12.19
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 9N
|
1.09 mcg/mL
Interval 0.75 to 1.6
|
1.10 mcg/mL
Interval 0.74 to 1.63
|
3.37 mcg/mL
Interval 2.11 to 5.4
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 9V
|
0.88 mcg/mL
Interval 0.65 to 1.18
|
1.08 mcg/mL
Interval 0.73 to 1.58
|
4.44 mcg/mL
Interval 2.75 to 7.16
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 10A
|
1.05 mcg/mL
Interval 0.58 to 1.88
|
1.38 mcg/mL
Interval 0.91 to 2.12
|
5.75 mcg/mL
Interval 3.63 to 9.11
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 11F
|
1.29 mcg/mL
Interval 0.91 to 1.84
|
1.08 mcg/mL
Interval 0.74 to 1.57
|
4.42 mcg/mL
Interval 2.95 to 6.61
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 12F
|
0.91 mcg/mL
Interval 0.57 to 1.43
|
2.33 mcg/mL
Interval 1.09 to 4.98
|
2.13 mcg/mL
Interval 1.3 to 3.49
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 14
|
2.06 mcg/mL
Interval 1.38 to 3.08
|
4.87 mcg/mL
Interval 3.05 to 7.79
|
12.29 mcg/mL
Interval 7.38 to 20.47
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 15B
|
1.25 mcg/mL
Interval 0.8 to 1.94
|
1.66 mcg/mL
Interval 1.24 to 2.22
|
5.76 mcg/mL
Interval 3.34 to 9.92
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 17F
|
1.48 mcg/mL
Interval 0.88 to 2.46
|
1.29 mcg/mL
Interval 0.98 to 1.71
|
5.57 mcg/mL
Interval 3.76 to 8.25
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 18C
|
2.29 mcg/mL
Interval 1.54 to 3.4
|
1.18 mcg/mL
Interval 0.85 to 1.62
|
7.14 mcg/mL
Interval 4.37 to 11.65
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 19A
|
2.35 mcg/mL
Interval 1.53 to 3.59
|
3.21 mcg/mL
Interval 1.76 to 5.84
|
9.56 mcg/mL
Interval 5.87 to 15.56
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 19F
|
1.74 mcg/mL
Interval 1.3 to 2.33
|
1.56 mcg/mL
Interval 1.09 to 2.24
|
4.91 mcg/mL
Interval 3.12 to 7.73
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 20
|
1.73 mcg/mL
Interval 1.13 to 2.66
|
2.59 mcg/mL
Interval 1.71 to 3.92
|
3.56 mcg/mL
Interval 2.31 to 5.5
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 22F
|
1.22 mcg/mL
Interval 0.7 to 2.12
|
1.09 mcg/mL
Interval 0.79 to 1.5
|
4.69 mcg/mL
Interval 3.11 to 7.09
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 23F
|
1.21 mcg/mL
Interval 0.83 to 1.77
|
1.07 mcg/mL
Interval 0.79 to 1.44
|
2.44 mcg/mL
Interval 1.58 to 3.76
|
|
Mean Level of Anti-Pneumococcal Antibody
8 weeks after 23-PPV: Serotype : 33F
|
1.36 mcg/mL
Interval 0.96 to 1.92
|
1.68 mcg/mL
Interval 1.23 to 2.3
|
5.01 mcg/mL
Interval 3.16 to 7.95
|
SECONDARY outcome
Timeframe: 4 weeks after seasonal influenza vaccine administrationPopulation: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
Seroprotection was defined as specific hemagglutination inhibition (HI) titers \>40 at 4 weeks after vaccination.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection
Strain = H1N1CA09
|
71.4 percentage of participants
|
97.0 percentage of participants
|
—
|
|
Percentage of Participants With Seroprotection
Strain = BPHU13
|
66.7 percentage of participants
|
80.6 percentage of participants
|
—
|
|
Percentage of Participants With Seroprotection
Strain = H3N2SW13
|
66.7 percentage of participants
|
92.6 percentage of participants
|
—
|
|
Percentage of Participants With Seroprotection
Strain = BBRIS08
|
55.6 percentage of participants
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With Seroprotection
Strain = AHK4801
|
80.0 percentage of participants
|
83.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after seasonal influenza vaccine administrationPopulation: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
2-fold increase from prevaccination HI titer.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Strain = H1N1CA09
|
45.7 percentage of participants
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Strain = BPHU13
|
42.4 percentage of participants
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Strain = H3N2SW13
|
36.7 percentage of participants
|
96.2 percentage of participants
|
—
|
|
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Strain = BBRIS08
|
27.8 percentage of participants
|
73.3 percentage of participants
|
—
|
|
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
Strain = AHK4801
|
80.0 percentage of participants
|
83.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after seasonal influenza vaccine administrationPopulation: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
4-fold increase from prevaccination HI titer.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Strain = BBRIS08
|
16.7 percentage of participants
|
53.3 percentage of participants
|
—
|
|
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Strain = H1N1CA09
|
20.0 percentage of participants
|
81.3 percentage of participants
|
—
|
|
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Strain = BPHU13
|
15.2 percentage of participants
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Strain = H3N2SW13
|
10.0 percentage of participants
|
92.3 percentage of participants
|
—
|
|
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
Strain = AHK4801
|
60.0 percentage of participants
|
66.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after influenza immunizationPopulation: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer \<10 and an HI titer \>40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer \<10 and HI titer \>/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer \>/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion
Strain = AHK4801 (as per FDA guidance)
|
60.0 percentage of participants
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = H1N1CA09 (as per FDA guidance)
|
20.0 percentage of participants
|
81.3 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = H1N1CA09 (as per protocol)
|
42.9 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = BPHU13 (as per FDA guidance)
|
12.1 percentage of participants
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = BPHU13 (as per protocol)
|
0 percentage of participants
|
55.6 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = H3N2SW13 (as per FDA guidance)
|
10.0 percentage of participants
|
88.5 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = H3N2SW13 (as per protocol)
|
20.0 percentage of participants
|
77.8 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = BBRIS08 (as per FDA guidance)
|
16.7 percentage of participants
|
53.3 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = BBRIS08 (as per protocol)
|
0 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With Seroconversion
Strain = AHK4801 (as per protocol)
|
—
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Strain-Specific Geometric Mean Titer Levels
Prior to influenza vaccine: Strain = H1N1CA09
|
126.5 hemagglutination inhibition titers
Interval 78.2 to 204.4
|
86.0 hemagglutination inhibition titers
Interval 55.4 to 133.6
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
4 weeks after influenza vaccine: Strain = H1N1CA09
|
154.8 hemagglutination inhibition titers
Interval 103.8 to 230.8
|
390.8 hemagglutination inhibition titers
Interval 264.0 to 578.4
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
Prior to influenza vaccine: Strain = BPHU13
|
67.7 hemagglutination inhibition titers
Interval 49.5 to 92.4
|
54.0 hemagglutination inhibition titers
Interval 34.6 to 84.3
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
4 weeks after influenza vaccine: Strain = BPHU13
|
84.6 hemagglutination inhibition titers
Interval 64.3 to 111.3
|
243.1 hemagglutination inhibition titers
Interval 156.3 to 377.9
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
Prior to influenza vaccine: Strain = H3N2SW13
|
110.0 hemagglutination inhibition titers
Interval 72.9 to 166.0
|
62.6 hemagglutination inhibition titers
Interval 41.2 to 95.2
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
4 weeks after influenza vaccine: Strain = H3N2SW13
|
134.5 hemagglutination inhibition titers
Interval 94.9 to 190.5
|
342.8 hemagglutination inhibition titers
Interval 219.1 to 536.3
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
Prior to influenza vaccine: Strain = BBRIS08
|
49.3 hemagglutination inhibition titers
Interval 35.2 to 69.0
|
71.3 hemagglutination inhibition titers
Interval 35.7 to 142.3
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
4 weeks after influenza vaccine: Strain = BBRIS08
|
65.8 hemagglutination inhibition titers
Interval 43.6 to 99.3
|
311.7 hemagglutination inhibition titers
Interval 167.4 to 580.5
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
Prior to influenza vaccine: Strain = AHK4801
|
52.8 hemagglutination inhibition titers
Interval 21.0 to 132.6
|
45.9 hemagglutination inhibition titers
Interval 32.4 to 65.2
|
—
|
|
Strain-Specific Geometric Mean Titer Levels
4 weeks after influenza vaccine: Strain = AHK4801
|
121.3 hemagglutination inhibition titers
Interval 70.4 to 208.8
|
127.0 hemagglutination inhibition titers
Interval 55.1 to 292.7
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to and 4 weeks after influenza vaccinePopulation: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.
Outcome measures
| Measure |
Group A (A1 + A2)
n=35 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain = H1N1CA09
|
1.31 ratio
Standard Deviation 1.04
|
5.74 ratio
Standard Deviation 21.05
|
—
|
|
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain = BPHU13
|
1.35 ratio
Standard Deviation 1.62
|
6.45 ratio
Standard Deviation 28.31
|
—
|
|
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain = H3N2SW13
|
1.25 ratio
Standard Deviation 0.94
|
8.18 ratio
Standard Deviation 11.70
|
—
|
|
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain = BBRIS08
|
1.38 ratio
Standard Deviation 1.90
|
4.68 ratio
Standard Deviation 9.19
|
—
|
|
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain = AHK4801
|
2.30 ratio
Standard Deviation 1.60
|
2.83 ratio
Standard Deviation 3.34
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
|
10.76 cubic centimeters (cm^3)
Standard Deviation 13.31
|
7.53 cubic centimeters (cm^3)
Standard Deviation 8.20
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Number of T2 Lesions
|
57.94 lesions
Standard Deviation 45.43
|
45.53 lesions
Standard Deviation 28.61
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Categorical Number of T2 Lesions
Baseline: 0-5 lesions
|
1 participants
|
0 participants
|
—
|
|
MRI Parameters: Categorical Number of T2 Lesions
Baseline: 6-9 lesions
|
1 participants
|
1 participants
|
—
|
|
MRI Parameters: Categorical Number of T2 Lesions
Baseline: >9 lesions
|
64 participants
|
33 participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
|
2.85 lesions
Standard Deviation 10.93
|
0.62 lesions
Standard Deviation 2.65
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Baseline: 0 lesions
|
44 participants
|
31 participants
|
—
|
|
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Baseline: 1 lesions
|
8 participants
|
0 participants
|
—
|
|
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Baseline: 2 lesions
|
2 participants
|
1 participants
|
—
|
|
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Baseline: 3 lesions
|
2 participants
|
0 participants
|
—
|
|
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
Baseline: >=4 lesions
|
9 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Normalized Brain Volume
|
1470.51 cm^3
Standard Deviation 77.83
|
1456.35 cm^3
Standard Deviation 70.03
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Volume of T2 Lesions: White Matter Volume
|
808.22 cm^3
Standard Deviation 60.11
|
794.53 cm^3
Standard Deviation 47.58
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Cortical Grey Matter Volume
|
521.19 cm^3
Standard Deviation 35.28
|
519.70 cm^3
Standard Deviation 36.18
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: T1 Unenhancing Lesion Volume
|
1.85 cm^3
Standard Deviation 2.75
|
1.31 cm^3
Standard Deviation 1.75
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: OC population included all randomized participants who completed the ISP.
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
MRI Parameters: Total Number of Lesions
|
25.51 lesions
Standard Deviation 27.76
|
18.85 lesions
Standard Deviation 15.99
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15, 85, 112, 140 and 169Population: Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants.
Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul. Repleted is defined as CD19 \>= LLN or baseline, whichever is lower.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Cellular Immune Response Assessed by Flow Cytometry
>=lower limit of normal range (LLN) - Day 1
|
97.0 percentage of participants
|
97.0 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 1
|
3.0 percentage of participants
|
3.0 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 1
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 1
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
>=LLN - Day 15
|
0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 15
|
100.0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 15
|
0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 15
|
100.0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
>=LLN - Day 85
|
0 percentage of participants
|
90.6 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 85
|
100.0 percentage of participants
|
9.4 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 85
|
0 percentage of participants
|
90.6 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 85
|
100.0 percentage of participants
|
9.4 percentage of participants
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
>=LLN - Day 112
|
0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 112
|
100.0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 112
|
0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 112
|
100.0 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
>=LLN - Day 140
|
1.5 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 140
|
98.5 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 140
|
1.5 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 140
|
98.5 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
>=LLN - Day 169
|
3.1 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
<LLN - Day 169
|
96.9 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 repleted - Day 169
|
3.1 percentage of participants
|
—
|
—
|
|
Cellular Immune Response Assessed by Flow Cytometry
CD19 not repleted - Day 169
|
96.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 85, and 169Population: Safety population included all participants who received any ocrelizumab or any vaccine.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Total Immunoglobulin
Day 1
|
13.45 grams per liter (g/L)
Standard Deviation 2.75
|
14.05 grams per liter (g/L)
Standard Deviation 3.01
|
—
|
|
Total Immunoglobulin
Day 85
|
13.45 grams per liter (g/L)
Standard Deviation 2.80
|
14.53 grams per liter (g/L)
Standard Deviation 3.19
|
—
|
|
Total Immunoglobulin
Day 169
|
13.26 grams per liter (g/L)
Standard Deviation 2.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 Weeks (ISP)Population: Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples.
Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibody Formation
Post-baseline
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibody Formation
Baseline
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During ISP (24 weeks for Group A and 12 weeks for Group B)Population: Safety population included all participants who received any ocrelizumab or any vaccine.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.
Outcome measures
| Measure |
Group A (A1 + A2)
n=68 Participants
Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.
|
Group B
n=34 Participants
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
Group B
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
AEs
|
82.4 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
Serious AEs
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
AEs Leading to Study Discontinuation
|
0 percentage of participants
|
0 percentage of participants
|
—
|
Adverse Events
Group A1
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Group A2
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Group B
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A1
n=33 participants at risk
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group A2
n=35 participants at risk
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group B
n=34 participants at risk
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. No study drug was administered.
|
|---|---|---|---|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
APPENDICITIS
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
HERPES ZOSTER DISSEMINATED
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Investigations
SARS-COV-2 TEST POSITIVE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LOBULAR BREAST CARCINOMA IN SITU
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
CAROTID ARTERY ANEURYSM
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
SYNCOPE
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
Other adverse events
| Measure |
Group A1
n=33 participants at risk
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group A2
n=35 participants at risk
Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.
|
Group B
n=34 participants at risk
Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. No study drug was administered.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Cardiac disorders
PALPITATIONS
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Ear and labyrinth disorders
VERTIGO
|
12.1%
4/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Eye disorders
VISION BLURRED
|
18.2%
6/33 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.0%
1/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
ANAL INCONTINENCE
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
DIARRHOEA
|
18.2%
6/33 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.3%
5/35 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
NAUSEA
|
18.2%
6/33 • Number of events 8 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
22.9%
8/35 • Number of events 11 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
TOOTHACHE
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Gastrointestinal disorders
VOMITING
|
6.1%
2/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
ASTHENIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
CYST
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
FATIGUE
|
48.5%
16/33 • Number of events 23 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
28.6%
10/35 • Number of events 13 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.6%
7/34 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
GAIT DISTURBANCE
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
6.1%
2/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
INJECTION SITE PAIN
|
12.1%
4/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
INJECTION SITE REACTION
|
9.1%
3/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
INJECTION SITE SWELLING
|
6.1%
2/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
PAIN
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
PERIPHERAL SWELLING
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
PYREXIA
|
9.1%
3/33 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
General disorders
TEMPERATURE INTOLERANCE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Immune system disorders
SEASONAL ALLERGY
|
9.1%
3/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
BRONCHITIS
|
12.1%
4/33 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
CONJUNCTIVITIS
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
COVID-19
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
EAR INFECTION
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
FUNGAL INFECTION
|
6.1%
2/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
GASTROENTERITIS
|
9.1%
3/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
HERPES ZOSTER
|
12.1%
4/33 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
INFLUENZA
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
LOCALISED INFECTION
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
NASOPHARYNGITIS
|
24.2%
8/33 • Number of events 17 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
31.4%
11/35 • Number of events 20 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.6%
7/34 • Number of events 16 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
ORAL HERPES
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
PHARYNGITIS
|
3.0%
1/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
PNEUMONIA
|
3.0%
1/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
PYELONEPHRITIS
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
SINUSITIS
|
6.1%
2/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
22.9%
8/35 • Number of events 11 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
26.5%
9/34 • Number of events 12 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
TOOTH INFECTION
|
6.1%
2/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
54.5%
18/33 • Number of events 80 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
31.4%
11/35 • Number of events 18 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
32.4%
11/34 • Number of events 24 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
39.4%
13/33 • Number of events 29 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
25.7%
9/35 • Number of events 14 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
26.5%
9/34 • Number of events 19 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
VIRAL INFECTION
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
18.2%
6/33 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
9.1%
3/33 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
FALL
|
12.1%
4/33 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
63.6%
21/33 • Number of events 56 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
54.3%
19/35 • Number of events 60 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
47.1%
16/34 • Number of events 36 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
6.1%
2/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Investigations
VITAMIN D DECREASED
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Investigations
WEIGHT INCREASED
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
24.2%
8/33 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.0%
7/35 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
26.5%
9/34 • Number of events 13 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
18.2%
6/33 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
25.7%
9/35 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
15.2%
5/33 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
12.1%
4/33 • Number of events 8 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.0%
1/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
18.2%
6/33 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.3%
5/35 • Number of events 10 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 10 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
BALANCE DISORDER
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
DIZZINESS
|
12.1%
4/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
22.9%
8/35 • Number of events 10 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
DYSAESTHESIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
HEADACHE
|
27.3%
9/33 • Number of events 17 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
34.3%
12/35 • Number of events 15 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
17.6%
6/34 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
HYPOAESTHESIA
|
12.1%
4/33 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.6%
7/34 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
MIGRAINE
|
9.1%
3/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
30.3%
10/33 • Number of events 11 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.3%
5/35 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.6%
7/34 • Number of events 10 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
MUSCLE SPASTICITY
|
6.1%
2/33 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
NEURALGIA
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
PARAESTHESIA
|
12.1%
4/33 • Number of events 8 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 11 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
SCIATICA
|
6.1%
2/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
SOMNOLENCE
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
SYNCOPE
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Nervous system disorders
TREMOR
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
ANXIETY
|
18.2%
6/33 • Number of events 8 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
DEPRESSION
|
12.1%
4/33 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
20.0%
7/35 • Number of events 8 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
INSOMNIA
|
12.1%
4/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
17.1%
6/35 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 5 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
POLLAKIURIA
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
12.1%
4/33 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Renal and urinary disorders
URINARY RETENTION
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.2%
5/33 • Number of events 9 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.4%
4/35 • Number of events 7 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.7%
5/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.6%
3/35 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
17.6%
6/34 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS DISCOMFORT
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
11.8%
4/34 • Number of events 4 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/35 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
HAND DERMATITIS
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
MILIARIA
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.9%
2/34 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
RASH
|
24.2%
8/33 • Number of events 13 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
14.3%
5/35 • Number of events 6 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
8.8%
3/34 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
6.1%
2/33 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Vascular disorders
HAEMATOMA
|
9.1%
3/33 • Number of events 3 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/35 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Vascular disorders
HYPERTENSION
|
3.0%
1/33 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
0.00%
0/34 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
|
Vascular disorders
RAYNAUD'S PHENOMENON
|
0.00%
0/33 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
5.7%
2/35 • Number of events 2 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
2.9%
1/34 • Number of events 1 • Baseline up 5 years, 10 months, 26 days
Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER