One Year Antibody Persistence After a Fourth Dose Boost o... | NCT01139021

ID	Type	Description	Link
EudraCT No 2009-018101-52

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B246_12_M12	Experimental	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	Biological: rMenB+OMV NZ
B246_12M13	Experimental	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	Biological: rMenB+OMV NZ
B13_15_27	Experimental	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.	Biological: rMenB+OMV NZ
B12_14_26	Experimental	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.	Biological: rMenB+OMV NZ
B_24_26	Experimental	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rMenB+OMV NZ	Biological	Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.	To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).	12 months post booster (fourth) vaccination.
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.	To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).	12 months post booster (fourth) vaccination.
Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953. Analysis was done on MITT population (Primary).	12 months post booster (fourth) vaccination.

Secondary Outcomes

Measure	Description	Time Frame
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.	To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female children, 23 to 27 months of age (naïve children)
Available for all the visits scheduled in the study;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
Available for all the visits scheduled in the study;
In good health as determined by medical history, physical examination, clinical judgment of the investigator.
Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;
Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols;
Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246_12M12/B246_12M13) or after their second dose of rMenB+OMV NZ (groups B13_15_27/B12_14_26) in V72P13E1 according to the protocol;
For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained;
In good health as determined by medical history, physical examination, clinical judgment of the investigator.

Exclusion Criteria:

Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
History of any meningococcal B vaccine administration;
Previous ascertained or suspected disease caused by N. meningitidis;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Antibiotics treatment within 6 days prior to enrolment;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
Any serious chronic or progressive disease
Known or suspected impairment/ alteration of the immune system,
Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day;
Family members and household members of research staff;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrolment (use of low or moderate doses of inhaled steroids is not an exclusion);
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment;
Participation in another clinical trial within 90 days prior to enrolment or planned for during study;
Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment);
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Facility	Status	City	State	ZIP	Country	Contacts
amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec		Hradec			Czechia
Dětské oddělení nemocnice Náchod

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	B246_12M12	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
FG001	B246_12M13

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	B246_12M12	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
BG001	B246_12M13	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
BG002	B13_15_27	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
BG003	B12_14_26	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
BG004	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
BG005	B12M13	Subject was randomized in group B13_15_27 but treated as group B12_M13.
BG006	Total	Total of all reporting groups

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

Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).

Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).

Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).

Posted

Geometric Mean

95% Confidence Interval

Titers

12 months post booster (fourth) vaccination.

ID	Title	Description
OG000	B246_12M12	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
OG001	B246_12M13	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
OG002	B246_12Tot	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age

Units	Counts
Participants	OG000147 OG001153 OG002300

Title

Denominators

Categories

H44/76-SL (N=147,152,299)

Title	Measurements
	OG0007.38(5.55 to 9.83) OG0018.3(6.17 to 11) OG0026.5(5.63 to 7.5)

5/99 (N=147,151,298)

Primary

Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).

Analysis was done on MITT population (Primary).

Posted

Number

95% Confidence Interval

Percentage of subjects

12 months post booster (fourth) vaccination.

ID	Title	Description
OG000	B246_12M12	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
OG001	B246_12M13	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
OG002	B246_12Tot	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age

Primary

Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953.

Analysis was done on MITT population (Primary).

Posted

Geometric Mean

95% Confidence Interval

Concentration IU/mL

12 months post booster (fourth) vaccination.

ID	Title	Description
OG000	B246_12M12	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
OG001	B246_12M13	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
OG002	B246_12Tot	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age

Secondary

GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.

Both the groups received MMRV at 12 months of age.

Analysis was done on MITT population (Secondary).

Posted

Geometric Mean

95% Confidence Interval

Titers

12 months post two catch-up dose vaccination and 6 months post booster dose.

ID	Title	Description
OG000	B13_15_27	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
OG001	B12_14_26	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
OG002	B12+B13Tot	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.

Secondary

Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.

Both the groups received MMRV at 12 months of age.

Analysis was done on MITT population (Secondary).

Posted

Number

95% Confidence Interval

Percentage of subjects

6month post booster dose and 12 months post two catch-up dose vaccination.

ID	Title	Description
OG000	B13_15_27	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
OG001	B12_14_26	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
OG002	B12+B13Tot

Secondary

Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.

To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.

Analysis was done on MITT population (Secondary).

Posted

Number

95% Confidence Interval

Percentage of Subjects

1 month post booster dose versus prebooster.

ID	Title	Description
OG000	B13_15_27	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
OG001	B12_14_26	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
OG002	B12+B13Tot

Secondary

GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.

To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.

Both the groups received MMRV at 12 months of age.

Analysis was done on MITT population (Secondary).

Posted

Geometric Mean

95% Confidence Interval

Concentration IU/mL

12 months post two catch-up dose vaccination and 6 months post booster dose.

ID	Title	Description
OG000	B13_15_27	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
OG001	B12_14_26	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
OG002	B12+B13Tot

Secondary

GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.

To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Analysis was done on MITT population (Secondary).

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month and 6 months post two catch-up doses.

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Analysis was done on MITT population (Secondary)

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month and 6 months post two catch-up doses.

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.

To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.

Analysis was done on MITT population (Secondary).

Posted

Number

95% Confidence Interval

Percentage of subjects

1 month post two catch-up doses versus prevaccination

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Secondary

GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.

To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.

Analysis was done on MITT population (Secondary).

Posted

Geometric Mean

95% Confidence Interval

Concentration IU/mL

1 month and 6 months post two catch-up doses.

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.

To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.

Posted

Number

Number of subjects

Up to 7 days after any vaccination.

ID	Title	Description
OG000	B13_15_27	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
OG001	B12_14_26	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.

Units	Counts
Participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.

To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.

The analysis was done on safety subset.

Posted

Number

Number of Subjects

Up to 7 days after any vaccination.

ID	Title	Description
OG000	B13_15_27	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
OG001	B12_14_26	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.

To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

The analysis was done on safety subset.

Posted

Number

Number of subjects

Up to 7 days after any vaccination.

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.

To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.

The analysis was done on safety subset.

Posted

Number

Number of Subjects

Up to 7 days after any vaccination

ID	Title	Description
OG000	B_24_26	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	B13_15_27	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.	2	67	67	67
EG001	B12_14_26	Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.	1	18	18	18
EG002	B24_26	Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.	6	112	110	112

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Adenoidal Hypertrophy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Enteritis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Metabolism and nutrition disorders	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Bronchitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Laryngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected18 at risk EG0020 affected112 at risk
Oral Herpes	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected18 at risk EG0020 affected112 at risk
Otitis Media	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk
Pneumonia Respiratory Syncytial	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0021 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Somnolence	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG00022 affected67 at risk EG0017 affected18 at risk EG00270 affected112 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0010 affected18 at risk EG00214 affected112 at risk
Speech Disorder Developmental	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected18 at risk EG0020 affected112 at risk
Crying	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00016 affected67 at risk EG0015 affected18 at risk EG00247 affected112 at risk
Induration	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected18 at risk EG0024 affected112 at risk
Injection Site Erythema	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00047 affected67 at risk EG00113 affected18 at risk EG002103 affected112 at risk
Injection Site Pain	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00063 affected67 at risk EG00116 affected18 at risk EG002109 affected112 at risk
Injection Site Swelling	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00035 affected67 at risk EG0019 affected18 at risk EG00258 affected112 at risk
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00022 affected67 at risk EG0016 affected18 at risk EG00246 affected112 at risk
Tenderness	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected18 at risk EG0020 affected112 at risk
Eating Disorder	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG00025 affected67 at risk EG0019 affected18 at risk EG00253 affected112 at risk
Irritability	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG00040 affected67 at risk EG00114 affected18 at risk EG00284 affected112 at risk
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected18 at risk EG0022 affected112 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected18 at risk EG00224 affected112 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0010 affected18 at risk EG00215 affected112 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected18 at risk EG00218 affected112 at risk
Bronchitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected18 at risk EG00214 affected112 at risk
Conjunctivitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected18 at risk EG00216 affected112 at risk
Ear Infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected18 at risk EG0026 affected112 at risk
Exanthema Subitum	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected18 at risk EG0021 affected112 at risk
Gastroenteritis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected18 at risk EG0026 affected112 at risk
Nasopharyngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0012 affected18 at risk EG0029 affected112 at risk
Otitis Media	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0011 affected18 at risk EG00218 affected112 at risk
Pharyngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected18 at risk EG0029 affected112 at risk
Pneumonia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected18 at risk EG0020 affected112 at risk
Rhinitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected18 at risk EG0028 affected112 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected18 at risk EG00220 affected112 at risk
Viral Infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0011 affected18 at risk EG00214 affected112 at risk

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections