| Primary | Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 8 weeks after TT vaccine | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | Participants received dual infusion of ocrelizumab (OCR) 300 milligrams (mg) on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: tetanus toxoid (TT) containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine (23-PPV) and repeated administration with keyhole limpet hemocyanin (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. | | OG001 | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Difference in positive response, Group A minus Group B | | | | | normal distribution approximation | -30.7 | | | 2-Sided | 95 | -50.5 | -10.8 | | | | | Superiority | | |
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| Secondary | Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 4 weeks after TT vaccine | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 4 weeks after TT vaccine | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Mean Levels of Anti-Tetanus Antibody | Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA). | OC population included all randomized participants who completed the ISP. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Immediately prior to and at 4 and 8 weeks after TT vaccine | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | Anti-KLH antibody levels were assessed by ELISA. | OC population included all randomized participants who completed the ISP. | Posted | | Geometric Mean | 95% Confidence Interval | titer units | | Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Mean Levels of Anti-KLH Antibody: Ig M | Anti-KLH antibody levels were assessed by ELISA. | OC population included all randomized participants who completed the ISP. | Posted | | Geometric Mean | 95% Confidence Interval | titer units | | Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 4 weeks after 23-PPV | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 4 weeks after 23-PPV | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 4 weeks after 23-PPV | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Mean Levels of Anti-Pneumococcal Antibody | Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID). | OC population included all randomized participants who completed the ISP. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | Immediately prior to and 4 weeks after 23-PPV | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | 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. | OC population included all randomized participants who completed the ISP. | Posted | | Number | | percentage of participants | | 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Mean Level of Anti-Pneumococcal Antibody | Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID). | OC population included all randomized participants who completed the ISP. | Posted | | Geometric Mean | 95% Confidence Interval | mcg/mL | | Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With Seroprotection | Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Number | | percentage of participants | | 4 weeks after seasonal influenza vaccine administration | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | 2-fold increase from prevaccination HI titer. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Number | | percentage of participants | | 4 weeks after seasonal influenza vaccine administration | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | 4-fold increase from prevaccination HI titer. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Number | | percentage of participants | | 4 weeks after seasonal influenza vaccine administration | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Seroconversion | 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. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Number | | percentage of participants | | 4 weeks after influenza immunization | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Strain-Specific Geometric Mean Titer Levels | Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Geometric Mean | 95% Confidence Interval | hemagglutination inhibition titers | | Baseline and Week 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination. | OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B). | Posted | | Geometric Mean | Standard Deviation | ratio | | Immediately prior to and 4 weeks after influenza vaccine | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | cubic centimeters (cm^3) | | Baseline | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Number of T2 Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | lesions | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Categorical Number of T2 Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | lesions | | Baseline | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Normalized Brain Volume | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | cm^3 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Volume of T2 Lesions: White Matter Volume | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | cm^3 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Cortical Grey Matter Volume | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | cm^3 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: T1 Unenhancing Lesion Volume | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | cm^3 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | MRI Parameters: Total Number of Lesions | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. | OC population included all randomized participants who completed the ISP. | Posted | | Mean | Standard Deviation | lesions | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Cellular Immune Response Assessed by Flow Cytometry | 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. | Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants. | Posted | | Number | | percentage of participants | | Days 1, 15, 85, 112, 140 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Total Immunoglobulin | | Safety population included all participants who received any ocrelizumab or any vaccine. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Days 1, 85, and 169 | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Anti-Drug Antibody Formation | Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors. | Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples. | Posted | | Number | | percentage of participants | | Up to 24 Weeks (ISP) | | | | ID | Title | Description |
|---|
| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | 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. | Safety population included all participants who received any ocrelizumab or any vaccine. | Posted | | Number | | percentage of participants | | During ISP (24 weeks for Group A and 12 weeks for Group B) | | | | ID | Title | Description |
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| OG000 | Group A (A1 + A2) | 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. | | OG001 | 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. |
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