Meningococcal DiseasePhase 3NCT01139021

One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

A Phase 3 study testing rMenB+OMV NZ in people with Meningococcal Disease, run by Novartis Vaccines at 19 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

One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age. Read more about this study

Who is it for?: Ages 23 to 27 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: rMenB+OMV NZ
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 508 participants
Where: 19 sitesin 2 countries
Study dates: Jun 2010to Sep 2011
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 23 to 27 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy male and female children, 23 to 27 months of age (naïve children)
Available for all the visits scheduled in the study;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
Available for all the visits scheduled in the study;
In good health as determined by medical history, physical examination, clinical judgment of the investigator.
Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;

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Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols;
Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246_12M12/B246_12M13) or after their second dose of rMenB+OMV NZ (groups B13_15_27/B12_14_26) in V72P13E1 according to the protocol;
For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained;
In good health as determined by medical history, physical examination, clinical judgment of the investigator.

Who cannot join

Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
History of any meningococcal B vaccine administration;
Previous ascertained or suspected disease caused by N. meningitidis;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Antibiotics treatment within 6 days prior to enrolment;

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Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
Any serious chronic or progressive disease
Known or suspected impairment/ alteration of the immune system,
Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day;
Family members and household members of research staff;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrolment (use of low or moderate doses of inhaled steroids is not an exclusion);
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment;
Participation in another clinical trial within 90 days prior to enrolment or planned for during study;
Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment);
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

Finland16 sites

University of Tampere Medical School, Vaccine Research Center Tampere
Biokatu 10, Pirkanmaa, 33520
Espoo Vaccine Research Clinic,
Espoo
Helsinki East, Vaccine Research Clinic,
Helsinki
Helsinki South, Vaccine Research Clinic,
Helsinki
Järvenpää, Vaccine Research Clinic
Jarvenpaa
Kokkola Vaccine Research Clinic
Kokkola
Kotka Vaccine Research Clinic
Kotka
Kuopio Vaccine Research Clinic
Kuopio
Lahti Vaccine Research Clinic
Lahti
Oulu Vaccine Research Clinic
Oulu
Pori Vaccine Research Clinic
Pori
Seinäjoki Vaccine Research Clinic
Seinäjoki
Tampere Vaccine Research Clinic
Tampere
Turku Vaccine Research Clinic
Turku
Vantaa East, Vaccine Research Clinic
Vantaa
Vantaa West, Vaccine Research Clinic
Vantaa

Other trials in Finland

Czechia3 sites

amostatná ordinace praktického lékaře pro děti a dorost Jindřichův Hradec
Hradec
Dětské oddělení nemocnice Náchod
Náchod
Dětské oddělení nemocnice Pardubice
Pardubice

Other trials in Czechia

About this study

Official title: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

Conditions: Meningococcal Disease
Being tested: rMenB+OMV NZ
Keywords: Children, Meningococcal disease, Prevention, Vaccination
Medical subject headings: Meningococcal Infections

What participants receive

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

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

Study groups in NCT01139021
Study group	Role	What they receive
B246_12_M12	Experimental	Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age. Receives: Biological: rMenB+OMV NZ
B246_12M13	Experimental	Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age. Receives: Biological: rMenB+OMV NZ
B13_15_27	Experimental	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age. Receives: Biological: rMenB+OMV NZ
B12_14_26	Experimental	Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age. Receives: Biological: rMenB+OMV NZ
B_24_26	Experimental	Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. Receives: Biological: rMenB+OMV NZ
B12M13	Experimental	Subject was randomized in group B13_15_27 but treated as group B12_M13. Receives: Biological: rMenB+OMV NZ

What is being measured

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

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

Secondary outcomes (12)

GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.
To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age.
Measured: 12 months post two catch-up dose vaccination and 6 months post booster dose.
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.
To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age.
Measured: 6month post booster dose and 12 months post two catch-up dose vaccination.
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.
To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.
Measured: 1 month post booster dose versus prebooster.
GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.
To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.
Both the groups received MMRV at 12 months of age.
Measured: 12 months post two catch-up dose vaccination and 6 months post booster dose.
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
Measured: 1 month and 6 months post two catch-up doses.
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
Measured: 1 month and 6 months post two catch-up doses.
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.
Analysis was done on MITT population (Secondary).
Measured: 1 month post two catch-up doses versus prevaccination
GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.
To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.
Analysis was done on MITT population (Secondary).
Measured: 1 month and 6 months post two catch-up doses.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.
Measured: Up to 7 days after any vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.
Measured: Up to 7 days after any vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
Measured: Up to 7 days after any vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.
Measured: Up to 7 days after any vaccination

Timeline

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

Jun 2010Sep 2011

First posted8 Jun 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionSep 2011

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.
Other trials for Meningococcal 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 508 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139021
Sponsor's protocol ID: V72P13E2
Other IDs: EudraCT No 2009-018101-52
Status last verified: Apr 2015
First submitted: 4 Jun 2010
Last updated: 10 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
ClinicalTrials.gov ID: NCT01139021
Acronym / sponsor ID: V72P13E2
Conditions: Meningococcal Disease
Keywords: Children, Meningococcal disease, Prevention, Vaccination
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 508 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Sep 2011 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 10 Apr 2015

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
B246_12_M12	Experimental	Biological: rMenB+OMV NZSubjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
B246_12M13	Experimental	Biological: rMenB+OMV NZSubjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
B13_15_27	Experimental	Biological: rMenB+OMV NZSubjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
B12_14_26	Experimental	Biological: rMenB+OMV NZSubjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
B_24_26	Experimental	Biological: rMenB+OMV NZSubjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
B12M13	Experimental	Biological: rMenB+OMV NZSubject was randomized in group B13_15_27 but treated as group B12_M13.

Who may qualify

Ages: 23 to 27 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (10 listed)

Healthy male and female children, 23 to 27 months of age (naïve children)
Available for all the visits scheduled in the study;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
Available for all the visits scheduled in the study;
In good health as determined by medical history, physical examination, clinical judgment of the investigator.

Key exclusion criteria (18 listed)

Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
History of any meningococcal B vaccine administration;
Previous ascertained or suspected disease caused by N. meningitidis;
For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;

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
rMenB+OMV NZSubjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.	Biological	B12M13, B12_14_26, B13_15_27, B246_12M13, B246_12_M12, B_24_26

Primary outcome

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

12 secondary outcomes

GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.
Time frame: 12 months post two catch-up dose vaccination and 6 months post booster dose.
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.
Time frame: 6month post booster dose and 12 months post two catch-up dose vaccination.
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.
Time frame: 1 month post booster dose versus prebooster.
GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.
Time frame: 12 months post two catch-up dose vaccination and 6 months post booster dose.
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
Time frame: 1 month and 6 months post two catch-up doses.
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
Time frame: 1 month and 6 months post two catch-up doses.
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
Time frame: 1 month post two catch-up doses versus prevaccination
GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.
Time frame: 1 month and 6 months post two catch-up doses.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
Time frame: Up to 7 days after any vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.
Time frame: Up to 7 days after any vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
Time frame: Up to 7 days after any vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.
Time frame: Up to 7 days after any vaccination

Results and safety

Results posted to the registry on 10 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
B246_12M12	152	151
B246_12M13	153	153
B13_15_27	67	67
B12_14_26	19	18
B_24_26	116	107
B12M13	1	1

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

Time frame: 12 months post booster (fourth) vaccination.. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	B246_12M12 n = 147	B246_12M13 n = 153	B246_12Tot n = 300
H44/76-SL (N=147,152,299)	7.38 (5.55 to 9.83)	8.3 (6.17 to 11)	6.5 (5.63 to 7.5)
5/99 (N=147,151,298)	68 (52 to 91)	90 (67 to 121)	81 (71 to 94)
NZ98/254	1.57 (1.24 to 1.99)	1.79 (1.4 to 2.29)	1.91 (1.7 to 2.15)
M10713 (N=143,148,291)	4.37 (3.24 to 5.9)	3.62 (2.65 to 4.94)	3.35 (2.88 to 3.9)

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

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

Time frame: 12 months post booster (fourth) vaccination.. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	B246_12M12 n = 147	B246_12M13 n = 153	B246_12Tot n = 300
H44/76-SL (hSBA ≥1:5) (N=147, 152, 299)	60 (51 to 68)	64 (56 to 71)	62 (56 to 67)
5/99 (hSBA ≥1:5) (N=147, 151, 298)	96 (91 to 98)	99 (95 to 100)	97 (95 to 99)
NZ98/254 (hSBA ≥1:5)	18 (12 to 25)	17 (11 to 24)	17 (13 to 22)
M10713 (hSBA ≥1:5) (N=143, 148, 291)	40 (32 to 48)	32 (25 to 41)	36 (31 to 42)
H44/76-SL (hSBA ≥1:8) (N=147, 152, 299)	44 (35 to 52)	47 (39 to 55)	45 (39 to 51)
5/99 (hSBA ≥1:8) (N=147, 151, 298)	96 (91 to 98)	98 (94 to 100)	97 (94 to 99)
NZ98/254 (hSBA ≥1:8) (N=147, 153, 300)	12 (7 to 19)	14 (9 to 21)	13 (10 to 18)
M10713 (hSBA ≥1:8) (N=143, 148, 291)	31 (23 to 39)	24 (17 to 31)	27 (22 to 33)

Population analysed: Analysis was done on MITT population (Primary).

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

Time frame: 12 months post booster (fourth) vaccination.. Geometric mean (95% Confidence Interval). Unit: Concentration IU/mL

Measure	B246_12M12 n = 148	B246_12M13 n = 153	B246_12Tot n = 301
Value	360 (293 to 442)	389 (314 to 482)	352 (317 to 391)

Population analysed: Analysis was done on MITT population (Primary).

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
B13_15_27	2 of 67 (3%)	67 of 67 (100%)	Not reported
B12_14_26	1 of 18 (5.6%)	18 of 18 (100%)	Not reported
B24_26	6 of 112 (5.4%)	110 of 112 (98.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rMenB+OMV NZ in people with Meningococcal Disease, run by Novartis Vaccines at 19 sites in 2 countries.

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 10 inclusion and 18 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Finland, Czechia. 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 10 Apr 2015). 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?

Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. (time frame: 12 months post booster (fourth) vaccination.). The study lists 3 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 NCT01139021.

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 10 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.

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

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (10 listed)

Key exclusion criteria (18 listed)

Interventions

Primary outcome

Results and safety

Participant flow

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

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

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

Adverse events

Research links

Related trials for Meningococcal Disease

Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years

A Study to Learn About the Safety of PENBRAYA During Pregnancy

Referral and contact

Questions about this trial

Participant flow

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

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

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

Adverse events