Trial Outcomes & Findings for Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine (NCT NCT01026974)

Last Updated: 2014-10-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

28 months after primary vaccination; Baseline for Naïve

Results posted on

2014-10-01

Participant Flow

Subjects were recruited from a single center.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	16	14	41	49
Overall Study COMPLETED	15	12	29	46
Overall Study NOT COMPLETED	1	2	12	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Withdrawal by Subject	0	1	7	2
Overall Study Lost to Follow-up	1	1	4	0
Overall Study Adverse Event	0	0	0	1
Overall Study Inappropriate enrollment	0	0	1	0

Baseline Characteristics

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4rMenB n=16 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=41 Participants 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.	Naive_6062 n=49 Participants 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.	Total n=120 Participants Total of all reporting groups
Age, Continuous	42.8 months STANDARD_DEVIATION 1.1 • n=5 Participants	43.1 months STANDARD_DEVIATION 0.9 • n=7 Participants	41.7 months STANDARD_DEVIATION 1.7 • n=5 Participants	61.3 months STANDARD_DEVIATION 0.7 • n=4 Participants	50.0 months STANDARD_DEVIATION 9.5 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	62 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants	28 Participants n=4 Participants	58 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 months after primary vaccination; Baseline for Naïve

Population: 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.

Outcome measures

Outcome measures
Measure	4rMenB n=15 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=40 Participants 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.
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. 44/76-SL strain (N = 14,14,39)	1.26 Titers Interval 0.9 to 1.76	2.55 Titers Interval 1.15 to 5.66	1.08 Titers Interval 0.97 to 1.2
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. 5/99 strain (N = 14,14,40)	41 Titers Interval 18.0 to 95.0	29 Titers Interval 18.0 to 47.0	1 Titers Interval 1.0 to 1.0
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. NZ98/254 strain (N = 15,14,39)	1 Titers Interval 1.0 to 1.0	1.74 Titers Interval 0.91 to 3.33	1 Titers Interval 1.0 to 1.0
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. M10713 strain ( N = 14,14,40)	3.6 Titers Interval 1.32 to 9.84	7.11 Titers Interval 3.61 to 14.0	4.82 Titers Interval 2.9 to 8.0

PRIMARY outcome

Timeframe: 28 months after primary vaccination; Baseline for Naïve

Population: Analysis was done on MITT population

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).

Outcome measures

Outcome measures
Measure	4rMenB n=15 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=40 Participants 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.
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. 44/76-SL strain (N = 14,14,39)	14 percentages of subjects Interval 2.0 to 43.0	36 percentages of subjects Interval 13.0 to 65.0	3 percentages of subjects Interval 0.065 to 13.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. 5/99 strain (N = 14,14,40)	93 percentages of subjects Interval 66.0 to 100.0	100 percentages of subjects Interval 77.0 to 100.0	0 percentages of subjects Interval 0.0 to 9.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. NZ98/254 strain (N = 15,14,39)	0 percentages of subjects Interval 0.0 to 22.0	14 percentages of subjects Interval 2.0 to 43.0	0 percentages of subjects Interval 0.0 to 9.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. M10713 strain (N = 14,14,40)	29 percentages of subjects Interval 8.0 to 58.0	79 percentages of subjects Interval 49.0 to 95.0	53 percentages of subjects Interval 36.0 to 68.0

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	4rMenB n=16 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=39 Participants 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.
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. Local	14 participants	14 participants	38 participants
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. Injection-site pain	10 participants	12 participants	34 participants
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. Injection-site erythema	13 participants	14 participants	36 participants
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. Injection-site swelling	9 participants	6 participants	10 participants
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. Injection-site induration	11 participants	5 participants	17 participants
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. Systemic	12 participants	11 participants	30 participants
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. Change in eating habits	5 participants	5 participants	13 participants
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. Sleepiness	6 participants	6 participants	20 participants
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. Vomiting	0 participants	2 participants	1 participants
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. Diarrhea	2 participants	1 participants	2 participants
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. Irritability	8 participants	11 participants	24 participants
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. Headache	2 participants	1 participants	4 participants
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. Arthralgia	2 participants	3 participants	9 participants
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. Rash	2 participants	1 participants	2 participants
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. Fever (≥38°C)	4 participants	1 participants	6 participants
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. Other	6 participants	10 participants	21 participants
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. Temperature (≥40°C)	0 participants	0 participants	1 participants
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. Antipyretic preventive medication used	4 participants	9 participants	19 participants
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. Antipyretic treatment medication used	3 participants	1 participants	5 participants
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. Medically attended fever	0 participants	0 participants	0 participants

SECONDARY outcome

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

Population: Analysis was done on MITT population.

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.

Outcome measures

Outcome measures
Measure	4rMenB n=14 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=39 Participants 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.
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age 44/76-SL strain (N = 13,14,39)	100 Titers Interval 50.0 to 200.0	114 Titers Interval 59.0 to 222.0	8.89 Titers Interval 5.83 to 14.0
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age 5/99 strain (N=14, 14, 39)	1007 Titers Interval 445.0 to 2277.0	926 Titers Interval 432.0 to 1988.0	27 Titers Interval 16.0 to 44.0
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age NZ98/254 strain (N=14, 14, 39)	2.15 Titers Interval 0.88 to 5.23	32 Titers Interval 14.0 to 71.0	1.91 Titers Interval 1.35 to 2.71
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age M10713 strain (N = 13,14,39)	10 Titers Interval 3.43 to 30.0	23 Titers Interval 13.0 to 41.0	6.04 Titers Interval 3.73 to 9.79

SECONDARY outcome

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

Population: Analysis was done on MITT population.

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.

Outcome measures

Outcome measures
Measure	4rMenB n=14 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=39 Participants 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.
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 44/76-SL strain (N = 13, 14, 39)	100 percentages of subjects Interval 75.0 to 100.0	100 percentages of subjects Interval 77.0 to 100.0	72 percentages of subjects Interval 55.0 to 85.0
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 5/99 strain (N=14, 14, 39)	100 percentages of subjects Interval 77.0 to 100.0	100 percentages of subjects Interval 77.0 to 100.0	87 percentages of subjects Interval 73.0 to 96.0
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 NZ98/254 strain (N=14, 14, 39)	21 percentages of subjects Interval 5.0 to 51.0	93 percentages of subjects Interval 66.0 to 100.0	23 percentages of subjects Interval 11.0 to 39.0
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 M10713 strain (N = 13, 14, 39)	69 percentages of subjects Interval 39.0 to 91.0	93 percentages of subjects Interval 66.0 to 100.0	62 percentages of subjects Interval 45.0 to 77.0

SECONDARY outcome

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

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=13 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=38 Participants 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.
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 44/76-SL strain (N = 11,14,37)	100 percentages of subjects Interval 72.0 to 100.0	93 percentages of subjects Interval 66.0 to 100.0	54 percentages of subjects Interval 37.0 to 71.0
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 5/99 strain (N = 12,14,38)	100 percentages of subjects Interval 74.0 to 100.0	100 percentages of subjects Interval 77.0 to 100.0	76 percentages of subjects Interval 60.0 to 89.0
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 NZ98/254 strain (N = 13,14,37)	23 percentages of subjects Interval 5.0 to 54.0	71 percentages of subjects Interval 42.0 to 92.0	11 percentages of subjects Interval 3.0 to 25.0
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 M10713 strain (N = 11,14,38)	18 percentages of subjects Interval 2.0 to 52.0	36 percentages of subjects Interval 13.0 to 65.0	5 percentages of subjects Interval 1.0 to 18.0

SECONDARY outcome

Timeframe: 20 months post booster/ Baseline for Naïve

Population: Analysis was done on the MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=14 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=46 Participants 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.
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 44/76-SL strain (N = 9,12,46)	9.37 Titers Interval 2.47 to 36.0	4.69 Titers Interval 1.98 to 11.0	1.09 Titers Interval 0.96 to 1.25
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 5/99 strain (N = 9,11,46)	334 Titers Interval 186.0 to 599.0	119 Titers Interval 56.0 to 252.0	1.17 Titers Interval 0.96 to 1.42
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 NZ98/254 strain (N = 10,12,46)	1 Titers Interval 1.0 to 1.0	1.63 Titers Interval 0.86 to 3.08	1 Titers Interval 1.0 to 1.0
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 M10713 strain (N = 8,11,45)	4.96 Titers Interval 1.03 to 24.0	5.51 Titers Interval 2.19 to 14.0	8.09 Titers Interval 5.13 to 13.0

SECONDARY outcome

Timeframe: 20 months post booster/ Baseline for Naïve

Population: This analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=10 Participants 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.	4rMenB+OMV NZ n=12 Participants 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.	Naive_4042 n=46 Participants 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.
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine 44/76-SL strain (N = 9,12,46)	67 percentages of subjects Interval 30.0 to 93.0	67 percentages of subjects Interval 35.0 to 90.0	4 percentages of subjects Interval 1.0 to 15.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine 5/99 strain (N = 9,11,46)	100 percentages of subjects Interval 66.0 to 100.0	100 percentages of subjects Interval 72.0 to 100.0	4 percentages of subjects Interval 1.0 to 15.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine NZ98/254 strain 10, 12, 46)	0 percentages of subjects Interval 0.0 to 31.0	17 percentages of subjects Interval 2.0 to 48.0	0 percentages of subjects Interval 0.0 to 8.0
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine M10713 strain (N = 8,11,45)	50 percentages of subjects Interval 16.0 to 84.0	45 percentages of subjects Interval 17.0 to 77.0	67 percentages of subjects Interval 51.0 to 80.0

SECONDARY outcome

Timeframe: 1 month post -vaccine dose two

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=31 Participants 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.	4rMenB+OMV NZ n=35 Participants 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.	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.
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 44/76-SL strain (N = 30,34)	100 percentages Interval 88.0 to 100.0	100 percentages Interval 90.0 to 100.0	—
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 5/99 strain (N = 31,34)	100 percentages Interval 89.0 to 100.0	100 percentages Interval 90.0 to 100.0	—
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 NZ98/254 strain (N=31, 35)	90 percentages Interval 74.0 to 98.0	89 percentages Interval 73.0 to 97.0	—
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 M10713 strain (N = 29,33)	72 percentages Interval 53.0 to 87.0	97 percentages Interval 84.0 to 100.0	—

SECONDARY outcome

Timeframe: 1 month post vaccine dose two

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=31 Participants 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.	4rMenB+OMV NZ n=35 Participants 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.	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.
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. 44/76-SL strain (N = 30,34)	74 Titers Interval 57.0 to 94.0	83 Titers Interval 67.0 to 103.0	—
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. 5/99 strain (N = 31,34)	247 Titers Interval 188.0 to 323.0	331 Titers Interval 254.0 to 432.0	—
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. NZ98/254 strain (N = 30,35)	16 Titers Interval 11.0 to 23.0	14 Titers Interval 9.81 to 21.0	—
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. M10713 strain (N = 29,33)	8.91 Titers Interval 5.19 to 15.0	44 Titers Interval 33.0 to 57.0	—

SECONDARY outcome

Timeframe: 1 month post vaccine dose 2

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=31 Participants 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.	4rMenB+OMV NZ n=35 Participants 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.	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.
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 44/76-SL strain (N = 29,34)	100 percentages of subjects Interval 88.0 to 100.0	100 percentages of subjects Interval 90.0 to 100.0	—
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 5/99 strain (N = 31,34)	100 percentages of subjects Interval 89.0 to 100.0	100 percentages of subjects Interval 90.0 to 100.0	—
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 NZ 98/254 strain (N = 30,35)	73 percentages of subjects Interval 54.0 to 88.0	69 percentages of subjects Interval 51.0 to 83.0	—
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 M10713 strain (N = 29,32)	24 percentages of subjects Interval 10.0 to 44.0	53 percentages of subjects Interval 35.0 to 71.0	—

SECONDARY outcome

Timeframe: 18 months post vaccine dose 2

Population: Analysis was done on the MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=24 Participants 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.	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.	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.
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. 44/76-SL strain	2.73 Titers Interval 1.54 to 4.84	—	—
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. 5/99 strain	24 Titers Interval 16.0 to 35.0	—	—
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. NZ98/254 strain	1 Titers Interval 1.0 to 1.0	—	—
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. M10713 strain (N = 23)	14 Titers Interval 6.78 to 27.0	—	—

SECONDARY outcome

Timeframe: 18 months post vaccine dose two

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=24 Participants 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.	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.	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.
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. 44/76-SL strain	38 percentages of subjects Interval 19.0 to 59.0	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. 5/99 strain	100 percentages of subjects Interval 86.0 to 100.0	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. NZ98/254 strain	0 percentages of subjects Interval 0.0 to 14.0	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. M10713 strain (N = 23)	83 percentages of subjects Interval 61.0 to 95.0	—	—

SECONDARY outcome

Timeframe: 28 months after primary vaccination/ Baseline for Naïve

Population: Analysis was done on MITT population.

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).

Outcome measures

Outcome measures
Measure	4rMenB n=14 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=39 Participants 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.
Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.	86 concentrations (AU/mL) Interval 43.0 to 173.0	103 concentrations (AU/mL) Interval 61.0 to 174.0	27 concentrations (AU/mL) Interval 22.0 to 35.0

SECONDARY outcome

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

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=15 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=39 Participants 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.
Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.	5187 concentrations (AU/mL) Interval 2924.0 to 9204.0	3662 concentrations (AU/mL) Interval 2065.0 to 6491.0	83 concentrations (AU/mL) Interval 52.0 to 133.0

SECONDARY outcome

Timeframe: 20 months post booster/ Baseline for Naïve

Population: Analysis was done on MITT population.

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.

Outcome measures

Outcome measures
Measure	4rMenB n=10 Participants 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.	4rMenB+OMV NZ n=12 Participants 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.	Naive_4042 n=46 Participants 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.
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	772 concentrations (AU/mL) Interval 395.0 to 1512.0	358 concentrations (AU/mL) Interval 201.0 to 640.0	25 concentrations (AU/mL) Interval 19.0 to 33.0

SECONDARY outcome

Timeframe: 1 month post vaccine dose two

Population: Analysis was done on the MITT population.

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.

Outcome measures

Outcome measures
Measure	4rMenB n=31 Participants 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.	4rMenB+OMV NZ n=35 Participants 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.	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.
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.	612 concentrations (AU/mL) Interval 329.0 to 1139.0	2164 concentrations (AU/mL) Interval 1663.0 to 2817.0	—

SECONDARY outcome

Timeframe: 18 months post vaccine dose 2

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=24 Participants 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.	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.	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.
Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.	87 concentrations (AU/mL) Interval 63.0 to 120.0	—	—

SECONDARY outcome

Timeframe: 1 month post booster / 1 month post dose 1

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=14 Participants 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.	4rMenB+OMV NZ n=14 Participants 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.	Naive_4042 n=38 Participants 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.
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	100 percentages of subjects Interval 77.0 to 100.0	100 percentages of subjects Interval 77.0 to 100.0	21 percentages of subjects Interval 10.0 to 37.0

SECONDARY outcome

Timeframe: 1 month post dose 2

Population: Analysis was done on MITT population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=31 Participants 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.	4rMenB+OMV NZ n=35 Participants 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.	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.
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	77 percentages of subjects Interval 59.0 to 90.0	97 percentages of subjects Interval 85.0 to 100.0	—

SECONDARY outcome

Timeframe: Day 1-7 after each vaccination

Population: Analysis was done on the Safety population

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.

Outcome measures

Outcome measures
Measure	4rMenB n=39 Participants 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.	4rMenB+OMV NZ n=48 Participants 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.	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.
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 Local	39 participants	48 participants	—
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 Injection-site pain	38 participants	46 participants	—
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 Injection-site erythema	38 participants	46 participants	—
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 Injection-site swelling	19 participants	32 participants	—
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 Injection-site induration	26 participants	28 participants	—
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 Systemic	39 participants	48 participants	—
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 Change in eating habits	20 participants	15 participants	—
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 Sleepiness	26 participants	26 participants	—
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 Vomiting	4 participants	7 participants	—
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 Diarrhea	4 participants	4 participants	—
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 Irritability	29 participants	29 participants	—
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 Headache	8 participants	12 participants	—
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 Arthralgia	13 participants	24 participants	—
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 Rash	3 participants	5 participants	—
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 Fever (≥38°C)	10 participants	10 participants	—
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 Other	21 participants	26 participants	—
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 Antipyretic Preventive medication used	24 participants	29 participants	—
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 Antipyretic Treatment medication used	8 participants	12 participants	—
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 Temperature(≥40°C)	1 participants	0 participants	—
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 Medically attended fever	1 participants	0 participants	—

Adverse Events

4rMenB

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

4rMenB+OMV NZ

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Naive_4042

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Naive_6062

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	4rMenB n=16 participants at risk 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.	4rMenB+OMV NZ n=14 participants at risk 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.	Naive_4042 n=41 participants at risk 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.	Naive_6062 n=48 participants at risk 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.
Blood and lymphatic system disorders Lymphadenitis	6.2% 1/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Gastrointestinal disorders Vomiting	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.4% 1/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Infections and infestations Croup infectious	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.4% 1/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Infections and infestations Gastroenteritis	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.4% 1/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	7.1% 1/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Nervous system disorders Encephalitis	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.4% 1/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Nervous system disorders Febrile convulsion	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.4% 1/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/16 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/14 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	0.00% 0/41 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.	2.1% 1/48 • Solicited AEs were collected from Day 1 to Day 7 after each vaccination, SAEs and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Days 1-91 for Naive_6062 group]. The population reported in this section is the safety population.

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60