Meningoccocal DiseasePhase 3NCT01894919

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

A Phase 3 study testing Bexsero® vaccine (1 dose at study month zero) and Bexsero® vaccine (2 doses 1 month apart) in people with Meningoccocal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 months to 12 yearsHealthy volunteers can take part
Conditions the study is for: Meningoccocal Disease, Meningococcal Meningitis
What is being tested?: Bexsero® vaccine (1 dose at study month zero) and Bexsero® vaccine (2 doses 1 month apart)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 851 participants
Where: 17 sitesin 2 countries
Study dates: Jun 2013to Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 months to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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;

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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 V7228 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

Who cannot join

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;

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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 V7228 study (Follow-on Subjects):
Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

Hungary9 sites

Site 37, Praxis Dr Julianna Kovacs
Bordány, Honved Utca 2, 6795
Site 40, General Pediatric Practice Hacsek
Budapest, Poth Iren U 80, 1188
Site 42, Praxis Dr Eszter Bari
Csongrád, Szentharomsag Ter 10, 6640
Site 34, General Pediatric Practice Somorjai
Debrecen, Bajcsi Ut 32, 4025
Site 31, General Practice Dr Olga Fekete
Miskolc, Kando Kalman Utca 1, 3534
Site 30, General Practice Dr Simko
Miskolc, Selyemret U. 1., 3527
Site 33, General Pediatric Practice Ujhelyi
Nyíregyháza, Szent Istvan U 10, 4400
Site 35, Praxis Dr Eva Kovacs
Szeged, Csongradi Sgt 63, 6723
Site 36, General Practice Dr Edit Oszlacs
Szeged, Debreceni Utca 10-14, 6723

Other trials in Hungary

Spain8 sites

Site 15
Almería, 04007
Site 16
Almería, 04120
Site 20
Barcelona, 08195
Site 17
Madrid, 28041
Site 18
Madrid, 28935
Site 13
Pontevedra, 36002
Site 10
Santiago de Compostela, 15706
Site 14
Seville, 41014

Other trials in Spain

About this study

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

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.

Conditions: Meningoccocal Disease, Meningococcal Meningitis
Being tested: Bexsero® vaccine (1 dose at study month zero), Bexsero® vaccine (2 doses 1 month apart)
Keywords: Meningococcal B disease,, Antibody persistence
Medical subject headings: Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bexsero® vaccine (1 dose at study month zero)Biological
Bexsero® vaccine (2 doses 1 month apart)Biological

Study groups in NCT01894919
Study group	Role	What they receive
2H3H511_V	Experimental	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. Receives: Biological: Bexsero® vaccine (1 dose at study month zero)
2H3H511_NV	No intervention	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.
3H5_11_V	Experimental	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. Receives: Biological: Bexsero® vaccine (1 dose at study month zero)
3H5_11_NV	No intervention	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.
68_11_V	Experimental	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. Receives: Biological: Bexsero® vaccine (1 dose at study month zero)
68_11_NV	No intervention	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.
02_2_5_V	Experimental	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. Receives: Biological: Bexsero® vaccine (1 dose at study month zero)
02_2_5_NV	No intervention	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.
02_6_10_V	Experimental	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. Receives: Biological: Bexsero® vaccine (1 dose at study month zero)
02_6_10_NV	No intervention	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.
NAIVE 123	Experimental	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Receives: Biological: Bexsero® vaccine (2 doses 1 month apart)
NAIVE_4A	Experimental	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Receives: Biological: Bexsero® vaccine (2 doses 1 month apart)
NAIVE_4B	Experimental	Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Receives: Biological: Bexsero® vaccine (2 doses 1 month apart)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
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).
Measured: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
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.
Measured: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
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.
Measured: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
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.
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.
Measured: At Day 1 in this study over one month after the completion of the vaccination course in the parent study
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 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.
Measured: At Day 1 in this study over visit 1 in the vaccination course in the parent study

Secondary outcomes (19)

Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
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.
Measured: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
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.
Measured: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
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.
Measured: One month after booster vaccination (day 31)/24-36 months (Visit 1)
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This 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.
Measured: From post primary visit in the parent study to visit 2 in this extension study
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This 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
Measured: From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study
The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
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.
Measured: At Visit 1 and one month post booster vaccination (Day 31)
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
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.
Measured: At Day 31 versus Day 1
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present 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.
Measured: Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination
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.
Measured: At Baseline and One month post second vaccination (Day 61)
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.
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.
Measured: At Baseline and One month post second vaccination (Day 61)
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.
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.
Measured: One month post second vaccination (Day 61)
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.
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.
Measured: At Baseline and One month post second vaccination (Day 61)
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.
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.
Measured: At one month after receiving second vaccination (Day 61) versus baseline (Day 1)
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
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.
Measured: From day 1 (6 hr) through day 7 after vaccination
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.
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.
Measured: 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 subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.
Measured: From day 1 (6 hr) through day 7 after vaccination
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.
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.
Measured: From day 1(6 hr) through day 7 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® 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.
Measured: From day 1 through day 7 after any vaccination
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.
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.
Measured: Throughout the entire study period (up to 2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Nov 2015

First posted10 Jul 2013 (estimated)
Study startJun 2013
Primary completionSep 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningoccocal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 851 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01894919
Sponsor's protocol ID: V72_28E1
Other IDs: 2012-000657-30
Status last verified: May 2018
First submitted: 26 Jun 2013
Last updated: 30 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.
PubMed 29253560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
Meningoccocal Disease

All Meningoccocal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01894919
Acronym / sponsor ID: V72_28E1
Conditions: Meningoccocal Disease, Meningococcal Meningitis
Keywords: Meningococcal B disease,, Antibody persistence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 851 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Jun 2013
Primary completion: Sep 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 10 Jul 2013 (estimated)
Results: Posted 7 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 13

Arm	Type	Receives
2H3H511_V	Experimental	Biological: Bexsero® vaccine (1 dose at study month zero)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.
2H3H511_NV	No intervention	–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.
3H5_11_V	Experimental	Biological: Bexsero® vaccine (1 dose at study month zero)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.
3H5_11_NV	No intervention	–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.
68_11_V	Experimental	Biological: Bexsero® vaccine (1 dose at study month zero)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.
68_11_NV	No intervention	–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.
02_2_5_V	Experimental	Biological: Bexsero® vaccine (1 dose at study month zero)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.
02_2_5_NV	No intervention	–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.
02_6_10_V	Experimental	Biological: Bexsero® vaccine (1 dose at study month zero)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.
02_6_10_NV	No intervention	–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.
NAIVE 123	Experimental	Biological: Bexsero® vaccine (2 doses 1 month apart)Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
NAIVE_4A	Experimental	Biological: Bexsero® vaccine (2 doses 1 month apart)Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
NAIVE_4B	Experimental	Biological: Bexsero® vaccine (2 doses 1 month apart)Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.

Who may qualify

Ages: 35 months to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (13 listed)

Healthy infants and children according to the following age groups:
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 whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bexsero® vaccine (1 dose at study month zero)	Biological	02_2_5_V, 02_6_10_V, 2H3H511_V, 3H5_11_V, 68_11_V
Bexsero® vaccine (2 doses 1 month apart)	Biological	NAIVE 123, NAIVE_4A, NAIVE_4B

Primary outcome

Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.

19 secondary outcomes

Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
Time frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
Time frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
Time frame: One month after booster vaccination (day 31)/24-36 months (Visit 1)
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study
Time frame: From post primary visit in the parent study to visit 2 in this extension study
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study.
Time frame: From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study
The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Time frame: At Visit 1 and one month post booster vaccination (Day 31)
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Time frame: At Day 31 versus Day 1
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Time frame: Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination
Time frame: At Baseline and One month post second vaccination (Day 61)
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.
Time frame: At Baseline and One month post second vaccination (Day 61)
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.
Time frame: One month post second vaccination (Day 61)
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.
Time frame: At Baseline and One month post second vaccination (Day 61)
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.
Time frame: At one month after receiving second vaccination (Day 61) versus baseline (Day 1)
Number of Subjects (35 Months to 7 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
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.
Time frame: 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.
Time frame: From day 1 (6 hr) through day 7 after vaccination
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.
Time frame: From day 1(6 hr) through day 7 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.
Time frame: From day 1 through day 7 after any vaccination
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.
Time frame: Throughout the entire study period (up to 2 months)

Results and safety

Results posted to the registry on 7 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2H3H511_V	98	96
2H3H511_NV	47	47
3H5_11_V	89	89
3H5_11_NV	43	43
68_11_V	81	78
68_11_NV	39	39
02_2_5_V	32	32
02_2_5_NV	36	36
02_6_10_V	91	91
02_6_10_NV	90	89
NAIVE 123	100	98
NAIVE_4A	55	55
NAIVE_4B	50	50

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains

Time frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	2H3H511 n = 140	3H5_11 n = 131	68_11 n = 119	NAIVE 123 n = 100	02_2_5 n = 68	NAIVE_4A n = 55	02_6_10 n = 179	NAIVE_4B n = 50
H44/76	51 (42.8 to 60)	53 (43.8 to 61.5)	61 (52 to 70.1)	38 (28.5 to 48.3)	52 (39.7 to 64.6)	27 (16.1 to 41)	58 (50.3 to 65.2)	20 (10 to 33.7)
5/99	84 (77.2 to 89.9)	88 (80.9 to 92.9)	93 (87.2 to 97.1)	3 (0.6 to 8.5)	79 (67.4 to 88.1)	4 (0.44 to 12.5)	85 (79.4 to 90.3)	8 (2.2 to 19.2)
NZ98/254	45 (36.6 to 53.6)	38 (29.8 to 47.1)	56 (46.9 to 65.4)	2 (0.24 to 7)	29 (19 to 41.7)	7 (2 to 17.6)	50 (42.2 to 57.3)	6 (1.3 to 16.5)
M10713	31 (22.8 to 39.5)	36 (27.1 to 45.7)	39 (29.4 to 48.3)	37 (26.8 to 47.2)	34 (22.6 to 46.6)	38 (24.8 to 52.1)	61 (53.0 to 68.0)	55 (40.2 to 69.3)

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

Primary outcome: Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains

Time frame: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	2H3H511 n = 140	3H5_11 n = 131	68_11 n = 119	NAIVE 123 n = 100	02_2_5 n = 68	NAIVE_4A n = 55	02_6_10 n = 179	NAIVE_4B n = 50
H44/76	28 (20.6 to 36.1)	26 (18.7 to 34.3)	32 (23.7 to 41.1)	18 (11 to 26.9)	24 (14.3 to 35.9)	16 (7.8 to 28.8)	34 (26.8 to 41.2)	10 (3.3 to 21.8)
5/99	80 (72.4 to 86.3)	82 (74.8 to 88.5)	89 (82 to 94.1)	2 (0.24 to 7)	73 (60.9 to 83.2)	4 (0.44 to 12.5)	66 (59.1 to 73.3)	6 (1.3 to 16.5)
NZ98/254	21 (14.9 to 29.2)	18 (12.1 to 26)	29 (20.7 to 37.6)	0 (0 to 3.6)	15 (7.3 to 25.4)	2 (0.05 to 9.7)	28 (21.5 to 35.1)	0 (0 to 7.1)
M10713	24 (16.5 to 32)	22 (14.4 to 30.4)	28 (20.2 to 37.9)	26 (17.3 to 35.9)	31 (19.9 to 43.4)	36 (23.1 to 50.2)	54 (46 to 61.4)	49 (34.4 to 63.7)

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

Primary outcome: The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains

Time frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects. Geometric mean (97.5% Confidence Interval). Unit: Titers

Measure	2H3H511 n = 140	3H5_11 n = 131	68_11 n = 119	NAIVE 123 n = 100	02_2_5 n = 68	NAIVE_4A n = 55	02_6_10 n = 179	NAIVE_4B n = 50
H44/76	4.17 (3.4 to 5.13)	4.48 (3.6 to 5.57)	5.62 (4.48 to 7.04)	2.79 (2.25 to 3.45)	3.97 (2.99 to 5.28)	2.33 (1.77 to 3.07)	5.75 (4.78 to 6.91)	1.93 (1.39 to 2.68)
5/99	44 (32 to 60)	52 (37 to 72)	83 (58 to 117)	1.15 (1.03 to 1.29)	21 (14 to 33)	1.2 (0.96 to 1.51)	21 (16 to 28)	1.38 (1.1 to 1.73)
NZ98/254	3.48 (2.78 to 4.36)	2.98 (2.35 to 3.78)	4.86 (3.8 to 6.22)	1.14 (1.06 to 1.22)	2.81 (2.07 to 3.82)	1.37 (1.17 to 1.61)	4.57 (3.74 to 5.59)	1.22 (1.06 to 1.41)
M10713	2.77 (2.06 to 3.71)	3.03 (2.2 to 4.16)	3.17 (2.3 to 4.38)	3.3 (2.52 to 4.32)	3.53 (2.38 to 5.25)	4.26 (2.61 to 6.97)	7.82 (6.04 to 10)	6.95 (4.18 to 12)

Population analysed: 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.

Primary outcome: 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.

Time frame: At Day 1 in this study over one month after the completion of the vaccination course in the parent study. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	2H3H511 n = 137	3H5_11 n = 130	68_11 n = 118	02_2_5 n = 68	02_6_10 n = 176
H44/76	0.029 (0.023 to 0.036)	0.022 (0.017 to 0.028)	0.03 (0.023 to 0.038)	0.028 (0.021 to 0.038)	0.042 (0.035 to 0.052)
5/99	0.023 (0.017 to 0.03)	0.031 (0.023 to 0.041)	0.054 (0.04 to 0.073)	0.045 (0.031 to 0.066)	0.049 (0.038 to 0.063)
NZ98/254	0.059 (0.047 to 0.074)	0.038 (0.03 to 0.048)	0.07 (0.055 to 0.09)	0.061 (0.044 to 0.083)	0.095 (0.077 to 0.12)
M10713	0.19 (0.13 to 0.28)	0.16 (0.11 to 0.25)	0.19 (0.12 to 0.29)	0.17 (0.11 to 0.28)	0.24 (0.17 to 0.32)

19 secondary outcomes are reported in the full results.

Adverse events

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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2H3H511_V	0 of 97 (0%)	91 of 97 (93.8%)	0 of 97
3H5_11_V	0 of 89 (0%)	84 of 89 (94.4%)	0 of 89
68_11_V	0 of 80 (0%)	75 of 80 (93.8%)	0 of 80
02_2_5_V	0 of 32 (0%)	31 of 32 (96.9%)	0 of 32
02_6_10_V	0 of 91 (0%)	86 of 91 (94.5%)	0 of 91
NAIVE 123	0 of 100 (0%)	97 of 100 (97%)	0 of 100
NAIVE_4A	0 of 55 (0%)	55 of 55 (100%)	0 of 55
NAIVE_4B	0 of 50 (0%)	50 of 50 (100%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29253560Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines and Diagnostics study chair

Novartis Vaccines

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Hungary, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains (time frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (13 listed)

Key exclusion criteria (21 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains

Primary outcome: Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains

Primary outcome: The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains

Primary outcome: 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.

Adverse events

Research links

Related trials for Meningoccocal Disease

Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains

Primary outcome: Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains

Primary outcome: The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains

Primary outcome: 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.

Adverse events