A Study Evaluating B Cell Levels In Infants Of Lactating... | NCT04998851

ID	Type	Description	Link
2021-000063-79	EudraCT Number

Name	Class
PPD Development, LP	INDUSTRY
Laboratory Corporation of America	INDUSTRY
Illingworth Research Group	UNKNOWN

Label	Type	Description	Intervention Names
Women with CIS or MS	Experimental	Lactating women with CIS or MS (in line with the locally approved indications) who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum. Women resuming treatment with ocrelizumab post-partum will be included only if the last exposure to ocrelizumab occurred more than 3 months before the last menstrual period to exclude any interference between fetal exposure and exposure via lactation.	Drug: Ocrelizumab

Name	Type	Description	Arm Group Labels	Other Names
Ocrelizumab	Drug	Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.

Measure	Description	Time Frame
Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion	Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022.	At Day 30
Estimated Average Oral Daily Infant Dosage (ADID)	ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters [µg/mL]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight [kilograms (kg)] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification [LLQ=160 nanograms/millilitres (ng/mL)] are imputed to zero for the calculation ADID.	Up to Day 60

Measure	Description	Time Frame
Absolute CD19+ B Cell Count in the Infant	Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).	At Day 30
Percentage of CD19+ B Cell in the Infant

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94158	United States
University Of Colorado

ID	Title	Description
FG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 milligrams (mg), as an intravenous (IV) infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 20, 2023	Jul 8, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion

Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022.

Full Analysis Set Infants (FASI) included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.

Posted

Number

95% Confidence Interval

percentage of participants

At Day 30

ID	Title	Description
OG000	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants	OG00010

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 30.85)

Primary

Estimated Average Oral Daily Infant Dosage (ADID)

ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters [µg/mL]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight [kilograms (kg)] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification [LLQ=160 nanograms/millilitres (ng/mL)] are imputed to zero for the calculation ADID.

Pharmacokinetic Analysis Set Mothers (PASM) included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

95% Confidence Interval

micrograms (µg)

Up to Day 60

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Absolute CD19+ B Cell Count in the Infant

Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).

FASI included all the infants of women in the FASM population. 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 Day 30

ID	Title	Description
OG000	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants	OG000

Secondary

Percentage of CD19+ B Cell in the Infant

Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).

FASI included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.

Posted

Median

Full Range

percentage of cells

At Day 30

ID	Title	Description
OG000	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants	OG000

Secondary

Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

micrograms/millilitres*day (μg/mL*day)

One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Average Concentration of Ocrelizumab in Breastmilk (Cmean)

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

μg/mL

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

μg/mL

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Median

Full Range

days

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Estimated Maximum Oral Daily Infant Dosage (MDID)

MDID was calculated at the subject level as the peak ocrelizumab milk concentration (μg/mL) multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother's first postpartum ocrelizumab infusion.

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

µg

Up to Day 60

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Average Relative Infant Dose (RID)

Average RID over 60 days was calculated as the ADID (mg/kg/day) divided by the maternal dosage (mg/kg/day) over 60 days multiplied by 100.

PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

percentage

Up to Day 60

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Serum Concentration of Ocrelizumab in the Infant at Day 30

Serum concentration of ocrelizumab in the infant measured at Day 30 after the mother's first ocrelizumab postpartum infusion. Concentrations reported as below the lower limit of quantification (LLQ=156 ng/mL) are set to zero for calculation of summary statistics.

Pharmacokinetic Analysis Set Infants (PASI) included all infants in the FASI with a serum sample to allow measurement of ocrelizumab concentration.

Posted

Mean

Standard Deviation

µg/mL

At Day 30

ID	Title	Description
OG000	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants	OG000

Secondary

Percentage of Mothers With Adverse Events (AEs)

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.

Safety Analysis Set Mothers (SAFM) included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab.

Posted

Number

percentage of participants

Up to approximately 73.3 weeks after first ocrelizumab dose

ID	Title	Description
OG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.

Units	Counts
Participants	OG000

Secondary

Percentage of Infants With AEs

Safety Analysis Set Infants (SAFI) included all the infants of women in the FASM population.

Posted

Number

percentage of infants

Up to approximately 73.3 weeks after first ocrelizumab dose administered to mother

ID	Title	Description
OG000	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants

Secondary

Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination

The immune response to MMR vaccine 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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units

Secondary

Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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) was 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 RU/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL.

AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Number analyzed refers to 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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants

Secondary

Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine

The immune response to DTP vaccine 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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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 Vaccine

The immune response to DTP vaccine 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).

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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 Vaccine

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts

Secondary

Percentage of Infants With Positive Humoral Response to DTP Vaccine

The immune response to DTP vaccine 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. Number analyzed refers to 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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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 Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine

The immune response to Hib vaccine 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.

Posted

Mean

Standard Deviation

micrograms 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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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 Vaccine

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 Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants

Secondary

Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine

The immune response to HBV vaccine 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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units

Secondary

Percentage of Infants With Positive Humoral Response to HBV Vaccine

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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants

Secondary

Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)

The immune response to PCV-13 vaccine 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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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

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.

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 of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo positional	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Strabismus	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected13 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Teething	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected13 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected13 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events3 affected13 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Bronchiolitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected13 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected13 at risk EG0015 events4 affected13 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Ear infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0013 events3 affected13 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected13 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected13 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Mastitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected13 at risk EG0014 events3 affected13 at risk
Oral herpes	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Otitis media	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Rhinovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Suspected COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected13 at risk EG0012 events2 affected13 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Vaginal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Varicella	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected13 at risk EG0010 events0 affected13 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Multiple sclerosis pseudo relapse	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Paraesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected13 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events2 affected13 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected13 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Infected dermal cyst	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Tonsillitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected13 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk

ID	Term
D009103	Multiple Sclerosis
D001942	Breast Feeding

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D005247	Feeding Behavior
D001519	Behavior

ID	Title	Description
BG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.
BG001	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mothers	Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information.	0	13	0	13	10	13
EG001	Infants	Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information 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.	0	13	0	13	12	13