Safety and Immunogenicity of GSK Meningococcal Group B Va... | NCT03621670

NCT03621670

ID	Type	Description	Link
2016-003268-37	EudraCT Number
V72_57	Other Identifier	Novartis

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MenB+PCV Group	Experimental	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.	Biological: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) Biological: Prevnar13 Biological: Pediarix Biological: Hiberix Biological: Rotarix Biological: M-M-R II Biological: Varivax Biological: Prevnar 20
Placebo+PCV Group	Placebo Comparator	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.	Biological: Prevnar13 Biological: Pediarix Biological: Hiberix Biological: Rotarix Biological: M-M-R II Biological: Varivax Biological: Placebo (saline water) Biological: Prevnar 20

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)	Biological	Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.	MenB+PCV Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1	Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1	Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61	Rotarix was administered orally; therefore, no administration site events were analyzed.	Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61		Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121		Day 121 to Day 127
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121		Day 121 to Day 127

Secondary Outcomes

Measure	Description	Time Frame
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301	The immune response to PCV13 is evaluated by measuring IgG levels using ECL assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the 4th vaccination.	At Day 331 (1 month after the fourth vaccination)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits).
Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born full-term (i.e. after a gestation period of ≥ 38 weeks).

Exclusion Criteria:

If any exclusion criterion applies, the subject must not be included in the study:

• Child in care

Each subject must not have:

Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study.
Hypersensitivity to latex.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
Abnormal function of the immune system resulting from:
- Clinical conditions.
- Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth.
- Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth.
- Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
Received immunoglobulins or any blood products from birth.
Received an investigational or non-registered medicinal product from birth.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
Study personnel as an immediate family or household member.
Current or previous, confirmed or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization.
Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent.
Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed.
Serious chronic illness.
Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35205	United States
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
FG001	Placebo+PCV Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 19, 2023	Dec 23, 2025

Masking Info

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

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1

Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.

Analysis was performed on the Solicited Safety Set, which included all participants who received a study vaccination and had solicited adverse event data available for the specified duration.

Posted

Count of Participants

Participants

Day 1 to Day 7

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000768 OG001394

Title

Denominators

Categories

Erythema, Bexsero

- ParticipantsOG000768
- ParticipantsOG0010

Title	Measurements
	OG000156

Primary

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1

Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 1 to Day 7

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61

Rotarix was administered orally; therefore, no administration site events were analyzed.

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 61 to Day 67

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants

Primary

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 61 to Day 67

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 121 to Day 127

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 121 to Day 127

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 301 to Day 307

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 301 to Day 307

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301

Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.

Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 301 to Day 330

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Primary

Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered at Day 1

An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.

Analysis was performed on the Unsolicited Safety Set, which included all participants who received a study vaccination and had unsolicited adverse event data available for the specified duration

Posted

Count of Participants

Participants

Day 1 to Day 30

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Primary

Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered at Day 61

Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 61 to Day 90

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Unsolicted AEs After the Third Vaccination Administered at Day 121

Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 121 to Day 150

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any Unsolicited AEs After the Fourth Vaccination Administered at Day 301

Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.

Posted

Count of Participants

Participants

Day 301 to Day 330

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Primary

Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

Analysis was performed on the Unsolicited Safety Set. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Count of Participants

Participants

Day 1 up to study end (Day 481 for participants who have not reached 6-month follow-up at the time of Protocol Amendment 7; Day 661 for all others)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group

Primary

Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)

Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the Per Protocol Set (PPS) for immunogenicity, which included all participants who received a study vaccination and provided immunogenicity data at one month after their third vaccination for at least 1 strain. Only participants with data available for the specified analysis at the specified timepoint were included.

Posted

Number

99.2% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Primary

Percentage of Participants With hSBA Titers >= LLOQ Against All Serogroup B Test Strains Combined (Composite Response)

The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

99.2% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Primary

Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217

Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95.8% Confidence Interval

Percentage of participants

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts

Primary

Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp), NZ98/254 (PorA P1.4), and M13520 (NHBA) and >= 16 for Strain 96217 (NadA) (Composite Response Across All Strains)

The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95.8% Confidence Interval

Percentage of participants

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Primary

Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination

The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

98.3% Confidence Interval

Microgram per milliliter(µg/mL)

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units

Secondary

Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301

The immune response to PCV13 is evaluated by measuring IgG levels using ECL assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the 4th vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL

The immune response to PCV13 is evaluated by measuring the percentage of participants with serum IgG concentrations ≥ 0.35 μg/mL for each of the 13 PCV13 antigens at 1 month after the third and fourth vaccinations.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination) and Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units

Secondary

Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])

The immune response to DTaP-HBV-IPV (Pediarix) vaccine is evaluated. IgG concentrations for pertussis antigens (PT, FHA, PRN) are measured at 1 month after the third vaccination and are expressed as international units per millilitre (IU/mL).

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Percentage of Participants With Antibodies Concentrations Against Hepatitis B Surface Antigen (AntiHBsAg) >= 10 mIU/mL

The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Hepatitis B (HepB) antigens are measured at 1 month after the third vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL

The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for diphtheria (D) and tetanus (T) were measured at 1 month after the third vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Percentage of Participants With Anti-polyribosyl-ribitol Phosphate (PRP) Concentration >= 0.15 µg/mL and >= 1 µg/mL

The immune response to Hib vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Haemophilus influenzae type b (Hib) are measured at 1 month after the third vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Adjusted GMCs for Anti-measles Antibodies

The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for measles antigens are measured using adjusted GMCs at 1 month after fourth vaccination and are expressed as milli-International Units per milliliter (mIU/mL).

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Adjusted GMCs for Anti-mumps Antibodies

The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for mumps antigens are measured using adjusted GMCs at 1 month after fourth vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

Arbitrary Units per milliliter (AU/mL)

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants

Secondary

Adjusted GMCs for Anti-rubella Antibodies

The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for rubella antigens are measured using adjusted GMCs at 1 month after fourth vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants

Secondary

Adjusted GMCs for Anti-Varicella (VV) Antibodies

The immune response to varicella (VV) vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for varicella antigens are measured using GMCs at 1 month after fourth vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants

Secondary

Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 301 (6 months after third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

Titer

At Day 151 (1 month after the third vaccination), Day 301 (6 months after the third vaccination), and Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At Day 331 (1 month after the fourth vaccination) compared to Day 301 (pre-fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 301 (6 months after the third vaccination) and Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)

A 4-fold rise in hSBA titers is defined as - if pre-vaccination titer <Limit of Detection (LOD), then a post-vaccination titer >= 4 times the LOD or >= LLOQ, whichever is greater; - if pre-vaccination titer is >= LOD but <LLOQ, then a post-vaccination titer >= 4 times the LLOQ; - if pre-vaccination titer is >= LLOQ, then a post-vaccination titer >= 4 times the pre-vaccination titer, where pre-vaccination titer=pre-4th dose titers (Day 301). This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 331 (1 month after the fourth vaccination) relative to Day 301 (pre-fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Units	Counts

Secondary

Percentage of Participants With Anti-HBs Antibody Concentrations >= 100 mIU/mL

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

GMCs for Anti-HBsAg Antibodies

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 1 IU/mL

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

GMCs for Anti-diphtheria and Anti-tetanus Antibodies

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 151 (1 month after the third vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies

Seroresponse is defined as post-vaccination anti-VZV virus, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentration >= a protective threshold among participants who were seronegative (antibody concentration < assay cut-off) before vaccination.

Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 331 (1 month after the fourth vaccination)

ID	Title	Description
OG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
OG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Bronchogenic cyst	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Influenza like illness	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
PFAPA syndrome	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Anaphylactic reaction	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Serum sickness	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Adenovirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Bronchiolitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0012 events2 affected403 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Complicated appendicitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Coxsackie viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Gastroenteritis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Influenza	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Picornavirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0012 events2 affected403 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Rhinovirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Tonsillitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Urinary tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Neuroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Febrile convulsion	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Seizure	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0014 events4 affected403 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00021 events20 affected781 at risk EG00123 events20 affected403 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Brachycephaly	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Craniofacial deformity	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Dacryostenosis congenital	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Kidney duplex	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Macrocephaly	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Plagiocephaly	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0013 events3 affected403 at risk
Strabismus congenital	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Tethered oral tissue	Congenital, familial and genetic disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0012 events2 affected403 at risk
Conductive deafness	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Ear pain	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected781 at risk EG0015 events5 affected403 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Astigmatism	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Dacryostenosis acquired	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Eczema eyelids	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Eye discharge	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0013 events3 affected403 at risk
Eye movement disorder	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Eye swelling	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events1 affected403 at risk
Eyelid oedema	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Eyelid rash	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Ocular hyperaemia	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Pseudostrabismus	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Scleral discolouration	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Swelling of eyelid	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0010 events0 affected403 at risk
Abnormal faeces	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Anal fissure	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0012 events2 affected403 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Constipation	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00032 events31 affected781 at risk EG00113 events12 affected403 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG000350 events334 affected781 at risk EG001193 events178 affected403 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Faeces hard	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Flatulence	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0011 events1 affected403 at risk
Food protein-induced enterocolitis syndrome	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00014 events14 affected781 at risk EG0019 events9 affected403 at risk
Gastrooesophageal reflux in neonate	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Gingival cyst	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Gingival disorder	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0011 events1 affected403 at risk
Infantile colic	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0012 events2 affected403 at risk
Infantile spitting up	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Mucous stools	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Oral mucosal eruption	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Post-tussive vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Protein-losing gastroenteropathy	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Regurgitation	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Retching	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Teething	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00084 events75 affected781 at risk EG00155 events46 affected403 at risk
Toothache	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG000328 events317 affected781 at risk EG001174 events159 affected403 at risk
Vomiting projectile	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Administration site erythema	General disorders	MedDRA v27.1	Systematic Assessment	EG000460 events460 affected781 at risk EG001170 events170 affected403 at risk
Administration site induration	General disorders	MedDRA v27.1	Systematic Assessment	EG000480 events480 affected781 at risk EG001180 events180 affected403 at risk
Administration site pain	General disorders	MedDRA v27.1	Systematic Assessment	EG000582 events582 affected781 at risk EG001201 events201 affected403 at risk
Administration site swelling	General disorders	MedDRA v27.1	Systematic Assessment	EG000322 events322 affected781 at risk EG001122 events122 affected403 at risk
Adverse drug reaction	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Adverse food reaction	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Chills	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Crying	General disorders	MedDRA v27.1	Systematic Assessment	EG000433 events432 affected781 at risk EG001163 events163 affected403 at risk
Fatigue	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Hypothermia	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Induration	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Inflammation	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Influenza like illness	General disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0010 events0 affected403 at risk
Injection site bruising	General disorders	MedDRA v27.1	Systematic Assessment	EG0006 events6 affected781 at risk EG0016 events6 affected403 at risk
Injection site discolouration	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Injection site dryness	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Injection site erythema	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Injection site induration	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Injection site laceration	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Injection site nodule	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Injection site rash	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0016 events2 affected403 at risk
Injection site reaction	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected781 at risk EG0011 events1 affected403 at risk
Injection site swelling	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Injection site urticaria	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected781 at risk EG0010 events0 affected403 at risk
Injury associated with device	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Irritability postvaccinal	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pain	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Peripheral swelling	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG000543 events521 affected781 at risk EG001184 events172 affected403 at risk
Swelling	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Swelling face	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Tenderness	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Vaccination site bruising	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Vaccination site irritation	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Food allergy	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0012 events2 affected403 at risk
Seasonal allergy	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Abscess limb	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Acute sinusitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events2 affected781 at risk EG0012 events1 affected403 at risk
Body tinea	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Bronchiolitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00031 events30 affected781 at risk EG00116 events13 affected403 at risk
Bronchitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Bullous impetigo	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0006 events6 affected781 at risk EG0015 events5 affected403 at risk
Candida infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0010 events0 affected403 at risk
Candida nappy rash	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00011 events10 affected781 at risk EG0013 events3 affected403 at risk
Cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Chronic sinusitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Conjunctivitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00020 events17 affected781 at risk EG00117 events15 affected403 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0010 events0 affected403 at risk
Conjunctivitis viral	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Coxsackie viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Croup infectious	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00025 events24 affected781 at risk EG0014 events3 affected403 at risk
Cystitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Dacryocystitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Ear infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0010 events0 affected403 at risk
Erythema infectiosum	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Exanthema subitum	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Eye infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0012 events1 affected403 at risk
Folliculitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Fungal skin infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0010 events0 affected403 at risk
Gastroenteritis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0008 events8 affected781 at risk EG0015 events5 affected403 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected781 at risk EG0011 events1 affected403 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0007 events7 affected781 at risk EG0013 events3 affected403 at risk
Impetigo	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected781 at risk EG0013 events3 affected403 at risk
Influenza	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00013 events13 affected781 at risk EG0013 events3 affected403 at risk
Injection site cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Laryngotracheitis obstructive	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Nail infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Nasopharyngitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00046 events40 affected781 at risk EG00120 events18 affected403 at risk
Onychomycosis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Oral candidiasis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0014 events4 affected403 at risk
Oral viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Otitis externa	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Otitis media	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00055 events47 affected781 at risk EG00137 events29 affected403 at risk
Otitis media acute	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00042 events33 affected781 at risk EG00128 events23 affected403 at risk
Otitis media chronic	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Paronychia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Parvovirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Periorbital cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pertussis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pharyngitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0011 events1 affected403 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0010 events0 affected403 at risk
Pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Pustule	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0013 events3 affected403 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected781 at risk EG0013 events3 affected403 at risk
Respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0012 events2 affected403 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Rhinitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0010 events0 affected403 at risk
Roseola	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Rotavirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Sinusitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0006 events6 affected781 at risk EG0016 events6 affected403 at risk
Skin candida	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0013 events3 affected403 at risk
Skin infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Suspected COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0011 events1 affected403 at risk
Tinea cruris	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG000149 events125 affected781 at risk EG00179 events62 affected403 at risk
Urinary tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0012 events2 affected403 at risk
Viral infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00014 events13 affected781 at risk EG0017 events7 affected403 at risk
Viral pharyngitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Viral rash	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00017 events16 affected781 at risk EG00112 events12 affected403 at risk
Wound infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Accident at home	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected781 at risk EG0010 events0 affected403 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0011 events1 affected403 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Eyelid injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Foreign body ingestion	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0011 events1 affected403 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Scar	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Scrotal injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0010 events0 affected403 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Blood lead increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Body temperature decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Body temperature increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Breath sounds abnormal	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Cardiac murmur	Investigations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Human rhinovirus test positive	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Occult blood positive	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Platelet count increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
SARS-CoV-2 test positive	Investigations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Serum ferritin decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0014 events4 affected403 at risk
Weight decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
White blood cell count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Breast milk substitute intolerance	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0012 events2 affected403 at risk
Feeding disorder	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG000544 events543 affected781 at risk EG001217 events216 affected403 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Milk soy protein intolerance	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Weight gain poor	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0010 events0 affected403 at risk
Acquired plagiocephaly	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Jaw clicking	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Joint noise	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0003 events2 affected781 at risk EG0010 events0 affected403 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0012 events2 affected403 at risk
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Drooling	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Fine motor delay	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Infant irritability	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0012 events2 affected403 at risk
Lethargy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Movement disorder	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Myoclonus	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Nystagmus	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Somnolence	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG000681 events681 affected781 at risk EG001322 events319 affected403 at risk
Speech disorder developmental	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Breath holding	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Dependent personality disorder	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Emotional distress	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Insomnia	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0015 events5 affected403 at risk
Irritability	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG000738 events713 affected781 at risk EG001345 events330 affected403 at risk
Middle insomnia	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Selective eating disorder	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Sleep disorder	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Renal hypertrophy	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Single functional kidney	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Epididymal cyst	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Genital labial adhesions	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Genital rash	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Penile adhesion	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected781 at risk EG0010 events0 affected403 at risk
Penile cyst	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Penile dermatitis	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Brief resolved unexplained event	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00058 events51 affected781 at risk EG00125 events20 affected403 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00044 events39 affected781 at risk EG00119 events17 affected403 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0015 events3 affected403 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00039 events31 affected781 at risk EG00120 events17 affected403 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected781 at risk EG0012 events2 affected403 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00027 events25 affected781 at risk EG00114 events12 affected403 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Upper respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0006 events6 affected781 at risk EG0015 events5 affected403 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Acne infantile	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected781 at risk EG0012 events2 affected403 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0008 events8 affected781 at risk EG0013 events3 affected403 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0011 events1 affected403 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG00041 events38 affected781 at risk EG00125 events22 affected403 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected781 at risk EG0014 events4 affected403 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG00016 events16 affected781 at risk EG00110 events10 affected403 at risk
Eczema infantile	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0007 events7 affected781 at risk EG0011 events1 affected403 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0013 events3 affected403 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Perioral dermatitis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Post inflammatory pigmentation change	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG000224 events216 affected781 at risk EG001117 events106 affected403 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0011 events1 affected403 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected781 at risk EG0011 events1 affected403 at risk
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0014 events4 affected403 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected781 at risk EG0010 events0 affected403 at risk
Umbilical erythema	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected781 at risk EG0014 events3 affected403 at risk
Child abuse	Social circumstances	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Cyanosis	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk
Flushing	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Lymphoedema	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0010 events0 affected403 at risk
Pallor	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected781 at risk EG0011 events1 affected403 at risk
Scalp haematoma	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected781 at risk EG0011 events1 affected403 at risk

ID	Term
D008589	Meningococcal Infections
D008581	Meningitis
D008585	Meningitis, Meningococcal

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases

ID	Term
C570015	4CMenB vaccine
C472675	PEDIARIX
C514867	Hiberix
C492457	RIX4414 vaccine
D022542	Measles-Mumps-Rubella Vaccine
D019433	Chickenpox Vaccine
D000068357	Saline Waters

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D012411	Rubella Vaccine
D022283	Herpesvirus Vaccines
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena

ID	Title	Description
BG000	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
BG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
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	MenB+PCV Group	Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.	0	781	35	781	771	781
EG001	Placebo+PCV Group	Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.	0	403	19	403	389	403