Extension Study Evaluating Antibody Persistence and Safet... | NCT01026974

ID	Type	Description	Link
EUDRACT 2009-013075-21

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4rMenB	Experimental	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB vaccine at 40 months of age in the present study.	Biological: rMenB
4rMenB+OMV NZ	Experimental	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.	Biological: rMenB+OMV NZ
Naive_4042	Experimental	Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Biological: rMenB+OMV NZ
Naive_6062	Experimental	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.	Biological: rMenB+OMV NZ

Name	Type	Description	Arm Group Labels	Other Names
rMenB	Biological		4rMenB
rMenB+OMV NZ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.	The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.	28 months after primary vaccination; Baseline for Naïve
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.	The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).	28 months after primary vaccination; Baseline for Naïve
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.	The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.	Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]

Secondary Outcomes

Measure	Description	Time Frame
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age	The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Oxford Vaccine Group, Center for Clinical Vaccinology and Tropical Medicine, Churchill Hospital		Oxford	Oxford	OX3 7LJ	United Kingdom

PubMed Identifier	Type	Citation	Retractions
24722351	Background	McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.
23958808

ID	Title	Description
FG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
FG001	4rMenB+OMV NZ

ID	Title	Description
BG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
BG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
BG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
BG003	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00114 BG00241 BG00349 BG004120

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

Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.

The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.

Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.

Geometric Mean

95% Confidence Interval

Titers

28 months after primary vaccination; Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Units	Counts
Participants	OG00015 OG00114 OG00240

Title

Denominators

Categories

44/76-SL strain (N = 14,14,39)

Title	Measurements
	OG0001.26(0.9 to 1.76) OG0012.55(1.15 to 5.66) OG0021.08(0.97 to 1.2)

5/99 strain (N = 14,14,40)

Secondary

Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.

Analysis was done on MITT population.

Geometric Mean

95% Confidence Interval

Titers

1 month post booster /1 month post dose 1 for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Primary

Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.

The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported.

The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).

Analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

28 months after primary vaccination; Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042

Primary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.

The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.

Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.

Number

participants

Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002

Secondary

Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age

The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.

Analysis was done on MITT population.

Number

95% Confidence Interval

percentages of subjects

1 month post-booster/ 1 month post-dose 1 for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Secondary

Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.

Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive_4042 group.

Analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

1 month post booster / 1 month post dose 1 for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002

Secondary

Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine

The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine -naïve subjects of the same age and reported as GMTs.

Analysis was done on the MITT population

Geometric Mean

95% Confidence Interval

Titers

20 months post booster/ Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Secondary

Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine

The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.

This analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

20 months post booster/ Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Secondary

Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age

The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.

Analysis was done on MITT population

Number

95% Confidence Interval

percentages

1 month post -vaccine dose two

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.

The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs.

Analysis was done on MITT population

Geometric Mean

95% Confidence Interval

Titers

1 month post vaccine dose two

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age

The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.

Analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

1 month post vaccine dose 2

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.

Analysis was done on the MITT population

Geometric Mean

95% Confidence Interval

Titers

18 months post vaccine dose 2

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.

Analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

18 months post vaccine dose two

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.

The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children.

GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA).

Analysis was done on MITT population.

Geometric Mean

95% Confidence Interval

concentrations (AU/mL)

28 months after primary vaccination/ Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Secondary

Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.

The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch-up dose of rMenB+ OMV NZ in children at 40 months.

Analysis was done on MITT population

Geometric Mean

95% Confidence Interval

concentrations (AU/mL)

1 month post booster /1 month post dose 1 for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Secondary

Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine

The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.

Analysis was done on MITT population.

Geometric Mean

95% Confidence Interval

concentrations (AU/mL)

20 months post booster/ Baseline for Naïve

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Secondary

Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age.

The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40- & 42- months or 60- & 62- months of age are reported.

Analysis was done on the MITT population.

Geometric Mean

95% Confidence Interval

concentrations (AU/mL)

1 month post vaccine dose two

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.

Analysis was done on MITT population

Geometric Mean

95% Confidence Interval

concentrations (AU/mL)

18 months post vaccine dose 2

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch-up dose of rMenB+OMV NZ in children at 40 months.

Analysis was done on MITT population

Number

95% Confidence Interval

percentages of subjects

1 month post booster / 1 month post dose 1

ID	Title	Description
OG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
OG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
OG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

Secondary

Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age

The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.

Analysis was done on MITT population

Geometric Mean

95% Confidence Interval

percentages of subjects

1 month post dose 2

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Secondary

Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age

The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.

Analysis was done on the Safety population

Number

participants

Day 1-7 after each vaccination

ID	Title	Description
OG000	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
OG001	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG0030 affected48 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Croup infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Encephalitis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG0030 affected48 at risk
Ear pain	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0024 affected41 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0000 affected16 at risk EG0012 affected14 at risk EG0026 affected41 at risk EG003
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG00013 affected16 at risk EG00114 affected14 at risk EG00240 affected41 at risk EG003
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG00011 affected16 at risk EG0015 affected14 at risk EG00226 affected41 at risk EG003
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG00010 affected16 at risk EG00112 affected14 at risk EG00238 affected41 at risk EG003
Injection site swelling	General disorders	MedDRA	Systematic Assessment	EG0009 affected16 at risk EG0016 affected14 at risk EG00220 affected41 at risk EG003
Irritability	General disorders	MedDRA	Systematic Assessment	EG0008 affected16 at risk EG00111 affected14 at risk EG00229 affected41 at risk EG003
Pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Pyrexia	General disorders		Systematic Assessment	EG0004 affected16 at risk EG0011 affected14 at risk EG00211 affected41 at risk EG003
Swelling	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Ear infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0023 affected41 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected14 at risk EG0021 affected41 at risk EG003
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected14 at risk EG0023 affected41 at risk EG003
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0024 affected41 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0021 affected41 at risk EG003
Varicella	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected16 at risk EG0013 affected14 at risk EG00213 affected41 at risk EG003
Hair follicle tumor benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0028 affected41 at risk EG003
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0006 affected16 at risk EG0016 affected14 at risk EG00226 affected41 at risk EG003
Eating disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0005 affected16 at risk EG0015 affected14 at risk EG00220 affected41 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0023 affected41 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected16 at risk EG0011 affected14 at risk EG0025 affected41 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG003
Ear tube insertion	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0020 affected41 at risk EG003
Induration	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected14 at risk EG0022 affected41 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected14 at risk EG0020 affected41 at risk EG003

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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	4rMenB	Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.	1	16	15	16
EG001	4rMenB+OMV NZ	Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.	1	14	14	14
EG002	Naive_4042	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	4	41	41	41
EG003	Naive_6062	Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.	1	48	48	48