| Primary | Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) | The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Week 6 of infant's life | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy | | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Median | Full Range | cells per microliter (cells/µL) | | At Week 6 of infant's life | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy | | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Median | Full Range | percentage of cells | | At Week 6 of infant's life | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth | Serum ocrelizumab concentrations were measured in the umbilical cord blood at birth (within 1 hour after delivery) to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. At delivery, blood samples from the umbilical cord were collected. Ocrelizumab serum concentration below the lower limit of quantification (LLOQ = 156 ng/ml) was set to zero. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. | Posted | | Median | Full Range | nanograms/milliliter (ng/mL) | | Within 1 hour after delivery (at birth, Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life | Serum ocrelizumab concentrations were measured were measured at 6 weeks of the infants life to evaluate whether there was placental transfer of ocrelizumab from the mother to the infant. Serum samples from the infant were collected. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Median | Full Range | ng/mL | | At Week 6 of infant's life | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Serum Concentration of Ocrelizumab in the Mother | Serum concentration of ocrelizumab in the mother during pregnancy (time frame of blood sampling: Week 24-30, Week 35) and at delivery (time frame of blood sampling: within 24 hours after delivery). Ocrelizumab serum concentration below the lower limit of quantification (LLOQ = 156 ng/ml) was set to zero. | FASW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Median | Full Range | ng/mL | | Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Women | Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth. |
| |
| Secondary | Percentage of Infants With Adverse Events | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Percentages have been rounded off. | Safety analysis set of infants (SAFI) included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. | Posted | | Number | | percentage of infants | | Up to approximately 71 weeks | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Mothers With Adverse Events | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Percentages have been rounded off. | Safety analysis set of women (SAFW) included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy. | Posted | | Number | | percentage of mothers | | Up to approximately 87.6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Women | Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth. |
| |
| Secondary | Infant Characteristics at Birth: Body Weight | Day 1 refers to the time an infant's birth. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. | Posted | | Mean | Standard Deviation | kilogram (kg) | | At birth (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Infant Characteristics at Birth: Head Circumference | Day 1 refers to the time an infant's birth. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | centimeter (cm) | | At birth (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Infant Characteristics at Birth: Body Length | Day 1 refers to the time an infant's birth. | FASI included all infants born to women in the FASW who were potentially exposed to ocrelizumab during pregnancy. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | cm | | At birth (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Pregnancies Resulting in Live Births, Therapeutic Abortions, or Stillbirth | Pregnancy outcomes analysed included live births (term and preterm, presence of congenital anomalies) and elective/therapeutic abortions and stillbirths. | SAFW included all enrolled pregnant women who were exposed to ocrelizumab either 0-6 months before the LMP or in the first trimester of pregnancy. | Posted | | Number | | percentage of pregnancies | | During pregnancy (anytime between 37 to 42 weeks of gestation) and at birth (at Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Women | Pregnant women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were enrolled. Ocrelizumab was not administered after enrollment in the study until the infant's birth. |
| |
| Secondary | Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to MMR Vaccination | The immune response to MMR vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. mIU/mL=milli-international units per milliliter. | Antibody immune response analysis set of infants (AIRI) included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | mIU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
|
| Secondary | Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination | The immune response to MMR vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. RU/mL=relative units per milliliter. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | RU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination | The immune response to MMR vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. IU/mL=international units per milliliter. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | IU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Infants With Positive Humoral Response to MMR Vaccination | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) are presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 mIU/mL; Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 U/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL. Percentages have been rounded off. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. Number analyzed= number of infants with data available for specified IgG antibody titer. | Posted | | Number | | percentage of infants | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccination | The immune response to DTP vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | IU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccination | The immune response to DTP vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows:
- COI < 0.95: Negative;
- COI 0.95-1.04: Equivocal;
- COI > 1.04: Positive. The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (>1.04).
| AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | COI | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
|
| Secondary | Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccination | The immune response to DTP vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | IU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Infants With Positive Humoral Response to DTP Vaccination | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for DTP vaccine are as follows: Anti-Diphtheria IgG(-70)CL and Anti-Tetanus Toxoid IgG(-70)RUO: ≥ 0.01 IU/mL; Bordetella pertussis antibodies, IgG: > 1.04 COI. COI = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows:
- COI < 0.95: Negative;
- COI 0.95-1.04: Equivocal;
- COI > 1.04: Positive. The assay used has not been standardized against WHO international units for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (>1.04).
| AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. Number analyzed refers to number of infants with data available for the specified IgG antibody titer. | Posted | | Number | | percentage of infants | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
|
| Secondary | Mean Titers of Antibody Immune Responses to Haemophilus Influenzae Type B (Hib) Vaccination | The immune response to Hib vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | microgram per milliliter (ug/mL) | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Infants With Positive Humoral Response to Hib Vaccination | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) will be presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Number | | percentage of infants | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Mean Titers of Antibody Immune Responses to Hepatitis B Virus (HBV) Vaccination | The immune response to HBV vaccination will be assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine is not planned to be administered. This is to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | mIU/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Infants With Positive Humoral Response to HBV Vaccination | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Number | | percentage of infants | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Mean Titers of Antibody Immune Responses to 13-valent Pneumococcal Conjugate (PCV-13) Vaccination | The immune response to PCV-13 vaccination was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Mean | Standard Deviation | ug/mL | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |
| Secondary | Percentage of Infants With Positive Humoral Response to PCV-13 Vaccination | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml. Percentages have been rounded off. | AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. | Posted | | Number | | percentage of infants | | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Infants | Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. |
| |