Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

Sponsor

Novartis Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT01894919

Collaborator

GlaxoSmithKline (Industry)

851

Enrollment

Locations

Arms

Duration (Months)

50.1

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study.

This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study.

Condition or Disease	Intervention/Treatment	Phase
Meningoccocal Disease Meningococcal Meningitis	Biological: Bexsero® vaccine (1 dose at study month zero) Biological: Bexsero® vaccine (2 doses 1 month apart)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

851 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Phase IIIb, Open Label, Multi Center Extension Study of V72_28 to Assess Antibody Persistence, and the Safety and Tolerability of a Booster Dose After the Completion of the Vaccination Course in Study V72_28

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2H3H511_V In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 2H3H511_NV In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 3H5_11_V In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 3H5_11_NV In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 68_11_V In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 68_11_NV In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.
Experimental: 02_2_5_V In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 02_2_5_NV In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
Experimental: 02_6_10_V In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Biological: Bexsero® vaccine (1 dose at study month zero)
No Intervention: 02_6_10_NV In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.
Experimental: NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Biological: Bexsero® vaccine (2 doses 1 month apart)
Experimental: NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Biological: Bexsero® vaccine (2 doses 1 month apart)
Experimental: NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Biological: Bexsero® vaccine (2 doses 1 month apart)

Outcome Measures

Primary Outcome Measures

Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains [24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects]
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains [At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects]
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains [24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects]
The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. [At Day 1 in this study over one month after the completion of the vaccination course in the parent study]
The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. [At Day 1 in this study over visit 1 in the vaccination course in the parent study]
The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.

Secondary Outcome Measures

Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. [At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)]
The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. [At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)]
The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. [One month after booster vaccination (day 31)/24-36 months (Visit 1)]
The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study [From post primary visit in the parent study to visit 2 in this extension study]
The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. [From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study]
The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02_2_5_V and 02_6_10_V
The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. [At Visit 1 and one month post booster vaccination (Day 31)]
The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. [At Day 31 versus Day 1]
The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. [Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study]
The within-subjects GMR of hSBA antibody titers (one month post booster vaccination in this study versus 1 month post last vaccination visit (post-primary vaccination visit) in parent study V72_28.
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination [At Baseline and One month post second vaccination (Day 61)]
The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. [At Baseline and One month post second vaccination (Day 61)]
The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. [One month post second vaccination (Day 61)]
The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. [At Baseline and One month post second vaccination (Day 61)]
The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. [At one month after receiving second vaccination (Day 61) versus baseline (Day 1)]
The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. [From day 1 (6 hr) through day 7 after vaccination]
The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study.
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. [From day 1 (6 hr) through day 7 after vaccination]
The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. [From day 1 (6 hr) through day 7 after vaccination]
Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. [From day 1(6 hr) through day 7 after vaccination]
The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. [From day 1 through day 7 after any vaccination]
The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. [Throughout the entire study period (up to 2 months)]
The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Months to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

For naïve subjects newly enrolled:

Healthy infants and children according to the following age groups:
Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age),
Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age).
Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age).
for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
in good health as determined by medical history, physical examination, clinical judgment of the investigator.

For Subjects who participated in the V72_28 study (Follow-on Subjects):

for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
for whom a parent/legal guardian confirmed availability for the visit scheduled in the study;
in good health as determined by medical history, physical examination, clinical judgment of the investigator
who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1

Exclusion Criteria:

For naïve subjects newly enrolled:

History of any serogroup B meningococcal vaccine administration;
Previous known or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

Receipt of any chronic immunosuppressive therapy
Receipt of any chronic immunostimulants
Immune deficiency disorder, or known HIV infection

History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable).
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
Intent to participate in another clinical study during this study.
Family members and household members of study staff;
History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
Any significant chronic infection.
Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

For Subjects who participated in the V72_28 study (Follow-on Subjects):

Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 34, General Pediatric Practice Somorjai	Debrecen	Bajcsi Ut 32	Hungary	4025
2	Site 35, Praxis Dr Eva Kovacs	Szeged	Csongradi Sgt 63	Hungary	6723
3	Site 36, General Practice Dr Edit Oszlacs	Szeged	Debreceni Utca 10-14	Hungary	6723
4	Site 37, Praxis Dr Julianna Kovacs	Bordany	Honved Utca 2	Hungary	6795
5	Site 31, General Practice Dr Olga Fekete	Miskolc	Kando Kalman Utca 1	Hungary	3534
6	Site 40, General Pediatric Practice Hacsek	Budapest	Poth Iren U 80	Hungary	1188
7	Site 30, General Practice Dr Simko	Miskolc	Selyemret U. 1.	Hungary	3527
8	Site 33, General Pediatric Practice Ujhelyi	Nyiregyhaza	Szent Istvan U 10	Hungary	4400
9	Site 42, Praxis Dr Eszter Bari	Csongrad	Szentharomsag Ter 10	Hungary	6640
10	Site 15	Almeria		Spain	04007
11	Site 16	Almeria		Spain	04120
12	Site 20	Barcelona		Spain	08195
13	Site 17	Madrid		Spain	28041
14	Site 18	Madrid		Spain	28935
15	Site 13	Pontevedra		Spain	36002
16	Site 10	Santiago de Compostela		Spain	15706
17	Site 14	Sevilla		Spain	41014

Sponsors and Collaborators

Novartis Vaccines
GlaxoSmithKline

Investigators

Study Chair: Novartis Vaccines and Diagnostics, Novartis Vaccines

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Vaccines

ClinicalTrials.gov Identifier:

NCT01894919

Other Study ID Numbers:

V72_28E1
2012-000657-30

First Posted:

Jul 10, 2013

Last Update Posted:

Nov 30, 2021

Last Verified:

May 1, 2018

Keywords provided by Novartis Vaccines

Meningococcal B disease,

Antibody persistence

Additional relevant MeSH terms:

Meningitis, Meningococcal

Meningitis

Vaccines

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 9 study sites in Hungary and 8 study sites in Spain.
Pre-assignment Detail	All enrolled subjects were included in the study.

Arm/Group Title	2H3H511_V	2H3H511_NV	3H5_11_V	3H5_11_NV	68_11_V	68_11_NV	02_2_5_V	02_2_5_NV	02_6_10_V	02_6_10_NV	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Period Title: Overall Study
STARTED	98	47	89	43	81	39	32	36	91	90	100	55	50
COMPLETED	96	47	89	43	78	39	32	36	91	89	98	55	50
NOT COMPLETED	2	0	0	0	3	0	0	0	0	1	2	0	0

Baseline Characteristics

Arm/Group Title	2H3H511_V	2H3H511_NV	3H5_11_V	3H5_11_NV	68_11_V	68_11_NV	02_2_5_V	02_2_5_NV	02_6_10_V	02_6_10_NV	NAIVE 123	NAIVE_4A	NAIVE_4B	Total
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Total of all reporting groups
Overall Participants	98	47	89	43	81	39	32	36	91	90	100	55	50	851
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	3.1 (0.2)	3 (0.18)	3.1 (0.23)	3.1 (0.22)	3.2 (0.29)	3.2 (0.26)	6.5 (1.15)	6.7 (1.16)	10.4 (1.43)	10.4 (1.44)	3.4 (0.29)	5.8 (1.12)	9.7 (1.38)	5.6 (3.20)
Sex: Female, Male (Count of Participants)
Female	44 44.9%	27 57.4%	48 53.9%	22 51.2%	35 43.2%	23 59%	19 59.4%	15 41.7%	44 48.4%	46 51.1%	46 46%	26 47.3%	27 54%	422 49.6%
Male	54 55.1%	20 42.6%	41 46.1%	21 48.8%	46 56.8%	16 41%	13 40.6%	21 58.3%	47 51.6%	44 48.9%	54 54%	29 52.7%	23 46%	429 50.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
Description	The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Time Frame	24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

Outcome Measure Data

Analysis Population Description
Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

Arm/Group Title	2H3H511	3H5_11	68_11	NAIVE 123	02_2_5	NAIVE_4A	02_6_10	NAIVE_4B
Arm/Group Description	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Measure Participants	140	131	119	100	68	55	179	50
H44/76	51	53	61	38	52	27	58	20
5/99	84	88	93	3	79	4	85	8
NZ98/254	45	38	56	2	29	7	50	6
M10713	31	36	39	37	34	38	61	55

2. Primary Outcome

Title	Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
Description	The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
Time Frame	At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

Arm/Group Title	2H3H511	3H5_11	68_11	NAIVE 123	02_2_5	NAIVE_4A	02_6_10	NAIVE_4B
Arm/Group Description	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Measure Participants	140	131	119	100	68	55	179	50
H44/76	28	26	32	18	24	16	34	10
5/99	80	82	89	2	73	4	66	6
NZ98/254	21	18	29	0	15	2	28	0
M10713	24	22	28	26	31	36	54	49

3. Primary Outcome

Title	The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
Description	The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
Time Frame	24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511	3H5_11	68_11	NAIVE 123	02_2_5	NAIVE_4A	02_6_10	NAIVE_4B
Arm/Group Description	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Measure Participants	140	131	119	100	68	55	179	50
H44/76	4.17	4.48	5.62	2.79	3.97	2.33	5.75	1.93
5/99	44	52	83	1.15	21	1.2	21	1.38
NZ98/254	3.48	2.98	4.86	1.14	2.81	1.37	4.57	1.22
M10713	2.77	3.03	3.17	3.3	3.53	4.26	7.82	6.95

4. Primary Outcome

Title	The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.
Description	The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
Time Frame	At Day 1 in this study over one month after the completion of the vaccination course in the parent study

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511	3H5_11	68_11	02_2_5	02_6_10
Arm/Group Description	Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).
Measure Participants	137	130	118	68	176
H44/76	0.029	0.022	0.03	0.028	0.042
5/99	0.023	0.031	0.054	0.045	0.049
NZ98/254	0.059	0.038	0.07	0.061	0.095
M10713	0.19	0.16	0.19	0.17	0.24

5. Primary Outcome

Title	The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.
Description	The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.
Time Frame	At Day 1 in this study over visit 1 in the vaccination course in the parent study

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02_2_5 & 02_6_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02_2_5 & 02_6_10.

Arm/Group Title	02_2_5	02_6_10
Arm/Group Description	Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01339923).	Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01339923).
Measure Participants	67	177
H44/76	1.88	2.94
5/99	20	14
NZ98/254	2.48	3.06
M10713	0.89	0.94

6. Secondary Outcome

Title	Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
Description	The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame	At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72_28 (excluding naïve groups).

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	96	87	76	32	91	96	55	50
H44/76 (pre-vacc.)	48	51	64	39	59	39	27	20
H44/76 (post-vacc.)	99	100	100	97	99	95	91	80
5/99 (pre-vacc.)	84	91	95	74	86	3	4	8
5/99 (post-vacc.)	99	99	97	100	100	88	93	80
NZ98/254 (pre-vacc.)	45	42	52	25	47	2	7	6
NZ98/254 (post-vacc.)	99	100	100	100	100	78	85	70
M10713 (pre-vacc.)	36	35	45	21	63	39	41	59
M10713 (post-vacc.)	70	81	97	97	96	47	59	60

7. Secondary Outcome

Title	Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
Description	The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame	At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	96	87	76	32	91	96	55	50
H44/76 (pre-vacc.)	26	31	33	19	30	18	16	10
H44/76 (post-vacc.)	97	98	99	97	97	68	71	60
5/99 (pre-vacc.)	79	85	91	71	68	2	4	6
5/99 (post-vacc.)	99	99	97	100	100	77	78	60
NZ98/254 (pre-vacc.)	22	19	28	13	26	0	2	0
NZ98/54 (post-vacc.)	97	98	100	97	97	34	54	40
M10713 (pre-vacc.)	28	22	34	17	55	27	39	52
M10713 (post-vacc.)	64	71	94	90	92	34	51	57

8. Secondary Outcome

Title	Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
Description	The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame	One month after booster vaccination (day 31)/24-36 months (Visit 1)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	92	87	76	32	91	96	55	50
H44/76 (Day 31/PRE)	95	95	97	94	97	43	53	46
5/99 (Day 31/PRE)	98	98	95	100	98	77	76	60
NZ98/254 (Day 31/PRE)	92	95	93	94	86	34	54	40
M10713 (Day 31/PRE)	41	50	68	72	53	11	20	13

9. Secondary Outcome

Title	Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study
Description	The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame	From post primary visit in the parent study to visit 2 in this extension study

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Measure Participants	94	86	76	32	89
H44/76	5	5	13	22	17
5/99	19	27	37	66	72
NZ98/254	25	15	27	13	18
M10713	15	21	24	21	11

10. Secondary Outcome

Title	Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study.
Description	The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02_2_5_V and 02_6_10_V
Time Frame	From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	02_2_5_V	02_6_10_V
Arm/Group Description	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Measure Participants	32	91
H44/76	97	96
5/99	100	100
NZ98/254	94	97
M10713	67	55

11. Secondary Outcome

Title	The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Description	The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.
Time Frame	At Visit 1 and one month post booster vaccination (Day 31)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	96	87	76	32	91	96	55	50
Geometric Mean (95% Confidence Interval) [Titers]	3.91	4.84	6.21	3.14	6.15	2.82	2.33	1.93

12. Secondary Outcome

Title	The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Description	The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.
Time Frame	At Day 31 versus Day 1

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	92	87	76	32	91	96	55	50
H44/76 (Day 31/PRE)	41	43	46	50	42	4.81	7.08	6.87
5/99 (Day 31/PRE)	75	67	41	160	135	34	22	14
NZ98/254 (Day 31/PRE)	28	29	27	24	18	6.07	9.58	7.01
M10713 (Day 31/PRE)	4.07	5.65	11	13	6.85	1.38	2.06	1.55

13. Secondary Outcome

Title	The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Description	The within-subjects GMR of hSBA antibody titers (one month post booster vaccination in this study versus 1 month post last vaccination visit (post-primary vaccination visit) in parent study V72_28.
Time Frame	Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V
Arm/Group Description	In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
Measure Participants	94	86	76
H44/76	1.06	0.90	1.37
5/99	1.60	2.07	2.33
NZ98/254	1.66	1.10	1.75
M10713	1.01	1.37	2.35

14. Secondary Outcome

Title	Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination
Description	The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.
Time Frame	At Baseline and One month post second vaccination (Day 61)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Arm/Group Title	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	98	54	49
H44/76 (baseline)	38	26	20
H44/76 (Day 61)	100	98	100
5/99 (baseline)	3	4	6
5/99 (Day 61)	100	100	100
NZ98/254 (baseline)	2	7	6
NZ98/254 (Day 61)	100	100	100
M10713 (baseline)	34	40	55
M10713 (Day 61)	75	69	76

15. Secondary Outcome

Title	Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.
Description	The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.
Time Frame	At Baseline and One month post second vaccination (Day 61)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Arm/Group Title	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	98	54	49
H44/76 (baseline)	17	15	10
H44/76 (Day 61)	99	96	98
5/99 (baseline)	2	4	4
5/99 (Day 61)	100	100	98
NZ98/254 (baseline)	0	2	0
NZ98/254 (Day 61)	96	93	94
M10713 (baseline)	25	38	49
M10713 (Day 61)	65	63	69

16. Secondary Outcome

Title	Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.
Description	The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.
Time Frame	One month post second vaccination (Day 61)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Arm/Group Title	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	98	54	49
H44/76	94	89	94
5/99	100	100	98
NZ98/254	94	91	94
M10713	37	28	22

17. Secondary Outcome

Title	The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.
Description	The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.
Time Frame	At Baseline and One month post second vaccination (Day 61)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Arm/Group Title	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	98	54	49
H44/76 (baseline)	2.3	2.15	1.56
H44/76 (Day 61)	107	74	63
5/99 (baseline)	1.13	1.13	1.31
5/99 (Day 61)	631	421	317
NZ98/254 (baseline)	1.11	1.34	1.2
NZ98/254 (Day 61)	34	37	34
M10713 (baseline)	2.9	4.12	6.4
M10713 (Day 61)	12	11	14

18. Secondary Outcome

Title	The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.
Description	The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.
Time Frame	At one month after receiving second vaccination (Day 61) versus baseline (Day 1)

Outcome Measure Data

Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

Arm/Group Title	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	98	54	49
H44/76	46	34	41
5/99	558	373	242
NZ98/254	30	27	29
M10713	3.86	2.93	2.2

19. Secondary Outcome

Title	Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
Description	The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study.
Time Frame	From day 1 (6 hr) through day 7 after vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Measure Participants	97	89	80	32
Any local AEs	87	81	73	31
Erythema	60	63	42	22
Induration	48	48	33	15
Swelling	49	50	37	20
Tenderness	84	80	71	31
Any systemic AEs	66	63	54	18
Change in eating habits	31	32	30	5
Diarrhea	4	8	5	0
Irritability	54	52	46	9
Persistent Crying	31	24	25	4
Rash	13	1	3	5
Sleepiness	28	23	26	5
Vomiting	5	5	2	1
Fever (>38.0° C)	17	18	11	2
Medically-Attended Fever	1	0	2	0
Prevention of Pain and/or Fever	23	14	15	1
Treatment of Pain and/or Fever	38	39	41	13

20. Secondary Outcome

Title	Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine.
Description	The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time Frame	From day 1 (6 hr) through day 7 after vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Arm/Group Title	NAIVE 123	NAIVE_4A
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	100	55
Any local AEs (1st vacc.)	88	55
Erythema (1st vacc.)	54	28
Induration (1st vacc.)	38	17
Swelling (1st vacc.)	40	24
Tenderness (1st vacc.)	87	55
Any systemic AEs (1st vacc.)	64	24
Change in Eating Habits (1st vacc.)	31	5
Diarrhea (1st vacc.)	4	3
Irritability (1st vacc.)	40	16
Persistent Crying (1st vacc.)	15	4
Rash (1st vacc.)	5	3
Sleepiness (1st vacc.)	18	9
Vomiting (1st vacc.)	7	2
Fever (>38.0° C) (1st vacc.)	15	2
Medically-Attended Fever (1st vacc.)	1	0
Prevention of Pain/Fever (1st vacc.)	18	3
Treatment of Pain/Fever (1st vacc.)	41	22
Any local AEs (2nd vacc.)	79	51
Erythema (2nd vacc.)	44	32
Induration (2nd vacc.)	29	22
Swelling (2nd vacc.)	32	25
Tenderness (2nd vacc.)	77	51
Any systemic AEs (2nd vacc.)	46	18
Change in Eating Habits (2nd vacc.)	15	9
Diarrhea (2nd vacc.)	2	3
Irritability (2nd vacc.)	25	11
Persistent Crying (2nd vacc.)	13	6
Rash (2nd vacc.)	2	1
Sleepiness (2nd vacc.)	12	5
Vomiting (2nd vacc.)	4	2
Fever (>38.0° C) (2nd vacc.)	12	3
Medically-Attended Fever (2nd vacc.)	0	1
Prevention of Pain/Fever (2nd vacc.)	21	4
Treatment of Pain/Fever (2nd vacc.)	30	13

21. Secondary Outcome

Title	Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
Description	Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.
Time Frame	From day 1 (6 hr) through day 7 after vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Arm/Group Title	02_6_10_V
Arm/Group Description	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Measure Participants	91
Any local AEs	85
Erythema	57
Induration	44
Swelling	52
Pain	84
Any systemic AEs	57
Arthralgia	18
Chills	23
Headache	27
Malaise	35
Myalgia	24
Nausea	12
Rash	10
Fever (>38.0° C)	10
Medically-Attended Fever	0
Prevention of Pain and/or Fever	12
Treatment of Pain and/or Fever	47

22. Secondary Outcome

Title	Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.
Description	The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time Frame	From day 1(6 hr) through day 7 after vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Arm/Group Title	NAIVE_4B
Arm/Group Description	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	50
Any local AEs (1st vacc.)	49
Erythema (1st vacc.)	31
Induration (1st vacc.)	19
Swelling (1st vacc.)	29
Pain (1st vacc.)	47
Any systemic AEs (1st vacc.)	24
Arthralgia (1st vacc.)	6
Chills (1st vacc.)	4
Headache (1st vacc.)	15
Malaise (1st vacc.)	7
Myalgia (1st vacc.)	12
Nausea (1st vacc.)	5
Rash (1st vacc.)	1
Fever (>38.0° C) (1st vacc.)	3
Medically-Attended Fever (1st vacc.)	0
Prevention of Pain and/or Fever (1st vacc.)	2
Treatment of Pain and/or Fever (1st vacc.)	21
Any local AEs (2nd vacc.)	43
Erythema (2nd vacc.)	21
Induration (2nd vacc.)	17
Swelling (2nd vacc.)	21
Pain (2nd vacc.)	41
Any systemic AEs (2nd vacc.)	25
Arthralgia (2nd vacc.)	3
Chills (2nd vacc.)	5
Headache (2nd vacc.)	10
Malaise (2nd vacc.)	13
Myalgia (2nd vacc.)	8
Nausea (2nd vacc.)	4
Rash (2nd vacc.)	3
Fever (>38.0° C) (2nd vacc.)	1
Medically-Attended Fever (2nd vacc.)	0
Prevention of Pain and/or Fever (2nd vacc.)	3
Treatment of Pain and/or Fever (2nd vacc.)	12

23. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.
Description	The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.
Time Frame	From day 1 through day 7 after any vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	96	89	78	32	91	100	55	50
Any AEs	26	19	26	9	14	43	25	12
Possibly or Probably Related AEs	9	7	10	6	11	12	10	6
AEs leading to Premature Withdrawal	0	0	0	0	0	1	0	0

24. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.
Description	The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.
Time Frame	Throughout the entire study period (up to 2 months)

Outcome Measure Data

Analysis Population Description
Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

Arm/Group Title	2H3H511_V	3H5_11_V	68_11_V	02_2_5_V	02_6_10_V	NAIVE 123	NAIVE_4A	NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	In the parent study V72_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Measure Participants	96	89	78	32	91	100	55	50
Any SAEs	0	0	0	0	0	0	0	0
Possibly or probably related SAEs	0	0	0	0	0	0	0	0

Adverse Events

	2H3H511_V		3H5_11_V		68_11_V		02_2_5_V		02_6_10_V		NAIVE 123		NAIVE_4A		NAIVE_4B
Time Frame	Solicited and unsolicited AEs were collected from Day 1 (30 minutes) throughout Day 7; SAEs were collected throughout the entire study period (up to 2 months)
Adverse Event Reporting Description	Subjects in the 2H3H511_NV Group, 3H5_11_NV Group, 68_11_NV Group, 02_2_5_NV Group and 02_6_10_NV Group were only evaluated for antibody persistence and hence not included in the safety analysis.

Arm/Group Title	2H3H511_V		3H5_11_V		68_11_V		02_2_5_V		02_6_10_V		NAIVE 123		NAIVE_4A		NAIVE_4B
Arm/Group Description	In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.		In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.		In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.		In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.		In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.		Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.		Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.		Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/89 (0%)		0/80 (0%)		0/32 (0%)		0/91 (0%)		0/100 (0%)		0/55 (0%)		0/50 (0%)
Serious Adverse Events
	2H3H511_V		3H5_11_V		68_11_V		02_2_5_V		02_6_10_V		NAIVE 123		NAIVE_4A		NAIVE_4B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/89 (0%)		0/80 (0%)		0/32 (0%)		0/91 (0%)		0/100 (0%)		0/55 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	2H3H511_V		3H5_11_V		68_11_V		02_2_5_V		02_6_10_V		NAIVE 123		NAIVE_4A		NAIVE_4B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/97 (93.8%)		84/89 (94.4%)		75/80 (93.8%)		31/32 (96.9%)		86/91 (94.5%)		97/100 (97%)		55/55 (100%)		50/50 (100%)
Gastrointestinal disorders
Diarrhoea	4/96 (4.2%)		8/89 (9%)		5/78 (6.4%)		0/32 (0%)		0/91 (0%)		7/100 (7%)		6/55 (10.9%)		0/50 (0%)
Nausea	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		12/91 (13.2%)		0/100 (0%)		0/55 (0%)		8/50 (16%)
Vomiting	5/96 (5.2%)		6/89 (6.7%)		2/78 (2.6%)		1/32 (3.1%)		0/91 (0%)		10/100 (10%)		5/55 (9.1%)		0/50 (0%)
General disorders
Chills	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		23/91 (25.3%)		0/100 (0%)		0/55 (0%)		7/50 (14%)
Crying	31/96 (32.3%)		24/89 (27%)		25/78 (32.1%)		4/32 (12.5%)		0/91 (0%)		23/100 (23%)		8/55 (14.5%)		0/50 (0%)
Injection site erythema	61/96 (63.5%)		63/89 (70.8%)		42/78 (53.8%)		22/32 (68.8%)		57/91 (62.6%)		65/100 (65%)		38/55 (69.1%)		37/50 (74%)
Injection site induration	48/96 (50%)		48/89 (53.9%)		33/78 (42.3%)		15/32 (46.9%)		44/91 (48.4%)		48/100 (48%)		28/55 (50.9%)		25/50 (50%)
Injection site pain	84/96 (87.5%)		80/89 (89.9%)		71/78 (91%)		31/32 (96.9%)		84/91 (92.3%)		94/100 (94%)		55/55 (100%)		48/50 (96%)
Injection site swelling	49/96 (51%)		50/89 (56.2%)		37/78 (47.4%)		20/32 (62.5%)		52/91 (57.1%)		51/100 (51%)		36/55 (65.5%)		34/50 (68%)
Malaise	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		35/91 (38.5%)		0/100 (0%)		0/55 (0%)		16/50 (32%)
Pyrexia	17/96 (17.7%)		18/89 (20.2%)		12/78 (15.4%)		2/32 (6.3%)		10/91 (11%)		25/100 (25%)		5/55 (9.1%)		4/50 (8%)
Infections and infestations
Pharyngitis	3/96 (3.1%)		2/89 (2.2%)		1/78 (1.3%)		0/32 (0%)		0/91 (0%)		2/100 (2%)		0/55 (0%)		15/50 (30%)
Tonsillitis	1/96 (1%)		1/89 (1.1%)		2/78 (2.6%)		0/32 (0%)		0/91 (0%)		6/100 (6%)		4/55 (7.3%)		1/50 (2%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		18/91 (19.8%)		0/100 (0%)		0/55 (0%)		8/50 (16%)
Myalgia	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		24/91 (26.4%)		0/100 (0%)		0/55 (0%)		15/50 (30%)
Nervous system disorders
Headache	0/96 (0%)		0/89 (0%)		0/78 (0%)		0/32 (0%)		27/91 (29.7%)		0/100 (0%)		1/55 (1.8%)		20/50 (40%)
Somnolence	28/96 (29.2%)		23/89 (25.8%)		26/78 (33.3%)		5/32 (15.6%)		0/91 (0%)		23/100 (23%)		10/55 (18.2%)		0/50 (0%)
Psychiatric disorders
Eating disorder	31/96 (32.3%)		32/89 (36%)		30/78 (38.5%)		5/32 (15.6%)		0/91 (0%)		36/100 (36%)		13/55 (23.6%)		0/50 (0%)
Irritability	54/96 (56.3%)		52/89 (58.4%)		46/78 (59%)		9/32 (28.1%)		0/91 (0%)		48/100 (48%)		19/55 (34.5%)		1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Cough	1/96 (1%)		0/89 (0%)		1/78 (1.3%)		2/32 (6.3%)		0/91 (0%)		2/100 (2%)		0/55 (0%)		0/50 (0%)
Skin and subcutaneous tissue disorders
Rash	13/96 (13.5%)		1/89 (1.1%)		3/78 (3.8%)		5/32 (15.6%)		10/91 (11%)		8/100 (8%)		4/55 (7.3%)		4/50 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.

Results Point of Contact

Name/Title	Posting Director
Organization	Novartis Vaccines
Phone
Email	RegistryContactVaccinesUS@novartis.com

Responsible Party:

Novartis Vaccines

ClinicalTrials.gov Identifier:

NCT01894919

Other Study ID Numbers:

V72_28E1
2012-000657-30

First Posted:

Jul 10, 2013

Last Update Posted:

Nov 30, 2021

Last Verified:

May 1, 2018

Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

For naïve subjects newly enrolled:

For Subjects who participated in the V72_28 study (Follow-on Subjects):

Exclusion Criteria:

For naïve subjects newly enrolled:

For Subjects who participated in the V72_28 study (Follow-on Subjects):

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact