Serogroup B Meningococcal MeningitisPhase 3NCT00657709

Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

A Phase 3 study testing Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) and Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) in people with Serogroup B Meningococcal Meningitis, run by Novartis Vaccines at 66 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines. Read more about this study

Who is it for?: Ages 55 to 89 daysHealthy volunteers can take part
Conditions the study is for: Serogroup B Meningococcal Meningitis
What is being tested?: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) and Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,630 participants
Where: 66 sitesin 5 countries
Study dates: Mar 2008to Jan 2010
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 55 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 2-month old infants (55-89 days, inclusive)

Who cannot join

Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
Previous ascertained or suspected disease caused by N. meningitidis
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Any serious chronic or progressive disease
Known or suspected impairment or alteration of the immune system

Trial locations and contacts

66 sites in 5 countries.

Country

City, postcode or hospital

66 sites in 5 countries

Czechia26 sites

Site 27
Boskovice, 680 01
Site 19
Brno, 628 00
Site11
Červený Kostelec, 54941
Site 22
Chomutov, 430 03
Site 14
Děčín, 405 01
Site 12
Havlíčkův Brod, 580 22
Site 8
Hradec Králové, 500 01
Site 9
Hradec Králové, 500 05
Site 28
Hranice I-mesto, 753 01
Site 13
Humpolec, 396 01
Site 15
Jindřichův Hradec, 377 01
Site 25
Kladno, 272 00
Site 21
Kolín, 280 02
Site 10
Liberec, 460 15
Site 24
Litoměřice, 412 01
Site 17
Ostrava, 702 00
Site 18
Ostrava-Poruba, 708 68
Site 7
Pardubice, 532 03
Site 16
Pilsen, 305 99
Site 2
Prague, 130 00
Site 3
Prague, 140 00
Site 5
Prague, 16000
Site 6
Prague, 19000
Site 26
Rumburk, 408 01
Site 23
Ústí nad Labem, 400 01
Site 20
Znojmo, 669 00

Other trials in Czechia

Finland15 sites

Site 30
Espoo, 02230
Site 31
Helsinki, 00100
Site 32
Helsinki, 00930
Site 34
Jarvenpaa, 04400
Site 35
Kokkola, 67100
Site 45
Kotka, 48600
Site 46
Kuopio, 70211
Site 47
Lahti, 15140
Site 49
Oulu, 90220
Site 50
Pori, 28100
Site 51
Seinäjoki, 60100
Site 52
Tampere, 33100
Site 53
Turku, 20520
Site 33
Vantaa, 01300
Site 48
Vantaa, 01600

Other trials in Finland

Germany12 sites

Site 99
Detmold, 32756
Site 92
Espelkamp, 32339
Site 95
Freising, 85354
Site 64
Fulda, 36037
Site 58
Lauffen am Neckar, 74348
Site 57
Marbach A. N., 74348
Site 97
München, 81377
Site 96
München, 81475
Site 91
Műnchen, 81737
Site 81
Porta Westfalica, 32457
Site 65
Schwieberdingen, 71701
Site 94
Weilheim, 82362

Other trials in Germany

Italy7 sites

Dipartimento di Scienze della Salute
Genova, 16132
Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
Messina, 98122
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan, 20122
Pediatria dell' Ospedale Sacco
Milan, 20157
Ospedale Maggiore della Carita'-Clinica Pediatrica
Novara, 28100
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, 07100
ASL/TA
Taranto, 74100

Other trials in Italy

Austria6 sites

Grässl
Hall in Tirol, 6060
Häckel
Kirchdorf, 4560
Prieler
Neufeld A.d. Leitha, 2491
Maurer
Salzburg, 5020
Sommer
Vienna, 1230
Angermayr
Wels, 4600

Other trials in Austria

About this study

Official title: A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Conditions: Serogroup B Meningococcal Meningitis
Being tested: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2), Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3), Infanrix Hexa, Menjugate
Keywords: infant, Meningococcal disease, prevention, vaccination
Medical subject headings: Meningitis, Meningococcal, Meningococcal Infections

What participants receive

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

Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)Biological
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)Biological
One dose of rMenB concomitantly with the routinely administered infant vaccines
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)Biological
One dose of rMenB concomitantly with the routinely administered infant vaccines
Infanrix HexaBiological
Routine vaccination
MenjugateBiological
One dose of the routinely administered infant vaccines + MenC vaccine
PrevenarBiological
Routine vaccination

Study groups in NCT00657709
Study group	Role	What they receive
rMenB Lot1	Experimental	Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. Receives: Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
rMenB Lot2	Experimental	Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. Receives: Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
rMenB Lot3	Experimental	Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. Receives: Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Routine	Active comparator	Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. Receives: Biological: Infanrix Hexa; Biological: Prevenar
MenC + Routine	Active comparator	Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. Receives: Biological: Infanrix Hexa; Biological: Menjugate; Biological: Prevenar

What is being measured

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

The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Measured: one month after the third vaccination
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
Measured: one month after the third vaccination

Secondary outcomes (9)

The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.
Measured: 1 month after the third vaccination
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.
Measured: 1 Month after the third vaccination
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Measured: 1 month after third vaccination
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.
Measured: 1 month after third vaccination
Percentages of Subjects With Antibody Response Against the Routine Antigens
The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.
HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml
Measured: 1 Month after third vaccination
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).
Measured: 5 months
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.
Measured: 1 Month after third vaccination
Percentage of Subjects With hSBA Titers ≥1:8
Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.
Measured: 1 month after third vaccination
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.
Measured: upto 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.

Mar 2008Jan 2010

First posted14 Apr 2008 (estimated)
Study startMar 2008
Primary completionJan 2010
Study completionJan 2010

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 (2)Papers the sponsor has linked to this study.
Other trials for Serogroup B Meningococcal MeningitisStudies 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: 3,630 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00657709
Sponsor's protocol ID: V72P13
Other IDs: EUDRACT 2007-007781-38
Status last verified: Sep 2017
First submitted: 2 Apr 2008
Last updated: 10 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
PubMed 31110098
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.
PubMed 23324563

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

Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons

All Serogroup B Meningococcal Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
ClinicalTrials.gov ID: NCT00657709
Acronym / sponsor ID: V72P13
Conditions: Serogroup B Meningococcal Meningitis
Keywords: infant, Meningococcal disease, prevention, vaccination
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,630 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Mar 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 14 Apr 2008 (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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
rMenB Lot1	Experimental	Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot2	Experimental	Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot3	Experimental	Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Routine	Active comparator	Biological: Infanrix Hexa, Biological: PrevenarSubjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
MenC + Routine	Active comparator	Biological: Infanrix Hexa, Biological: Menjugate, Biological: PrevenarSubjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.

Who may qualify

Ages: 55 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy 2-month old infants (55-89 days, inclusive)

Key exclusion criteria (5 listed)

Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
Previous ascertained or suspected disease caused by N. meningitidis
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Any serious chronic or progressive disease
Known or suspected impairment or alteration of the immune system

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
Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)One dose of rMenB Lot concomitantly with the routinely administered infant vaccines	Biological	rMenB Lot1
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)One dose of rMenB concomitantly with the routinely administered infant vaccines	Biological	rMenB Lot2
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)One dose of rMenB concomitantly with the routinely administered infant vaccines	Biological	rMenB Lot3
Infanrix HexaRoutine vaccination	Biological	MenC + Routine, Routine
MenjugateOne dose of the routinely administered infant vaccines + MenC vaccine	Biological	MenC + Routine
PrevenarRoutine vaccination	Biological	MenC + Routine, Routine

Primary outcome

The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
Time frame: one month after the third vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
Time frame: one month after the third vaccination
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.

9 secondary outcomes

The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
Time frame: 1 month after the third vaccination
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
Time frame: 1 Month after the third vaccination
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
Time frame: 1 month after third vaccination
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Time frame: 1 month after third vaccination
Percentages of Subjects With Antibody Response Against the Routine Antigens
Time frame: 1 Month after third vaccination
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Time frame: 5 months
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
Time frame: 1 Month after third vaccination
Percentage of Subjects With hSBA Titers ≥1:8
Time frame: 1 month after third vaccination
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Time frame: upto 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
rMenB Lot1	833	810
rMenB Lot2	828	795
rMenB Lot3	820	792
Routine	659	645
MenC+ Routine	490	457

Primary outcome: The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination

Time frame: one month after the third vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	rMenB Lot1 n = 386	rMenB Lot2 n = 380	rMenB Lot3 n = 394
44/76-SL strain (Baseline)	1.21 (1.14 to 1.29)	1.19 (1.12 to 1.27)	1.19 (1.12 to 1.27)
44/76-SL strain one month after 3rd vaccination	87 (80 to 95)	98 (90 to 106)	85 (78 to 93)
5/99 strain (Baseline)	1.21 (1.14 to 1.3)	1.2 (1.12 to 1.28)	1.21 (1.13 to 1.29)
5/99 strain one month after 3rd vaccination	598 (550 to 651)	681 (626 to 741)	607 (558 to 661)
NZ98/254 strain (Baseline)	1.03 (1 to 1.06)	1.06 (1.03 to 1.1)	1.04 (1 to 1.07)
one month after 3rd vaccination	15 (13 to 17)	14 (12 to 16)	15 (14 to 17)

rMenB Lot1 vs rMenB Lot2: hSBA GMT ratios: 0.9 (95% CI 0.81 to 0.99), ANOVA
rMenB Lot1 vs rMenB Lot3: hSBA GMT ratios: 1.02 (95% CI 0.93 to 1.13), ANOVA
rMenB Lot2 vs rMenB Lot3: hSBA GMT ratios: 1.14 (95% CI 1.03 to 1.27), ANOVA

Population analysed: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.

Primary outcome: The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)

Time frame: one month after the third vaccination. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	rMenB All n = 1160	Routine n = 121
44/76-SL strain (Baseline)	3 (2 to 4)	3 (1 to 8)
44/76-SL strain-1 Month after 3rd vaccination	100 (99 to 100)	3 (1 to 7)
5/99 strain (Baseline)	4 (3 to 5)	7 (3 to 13)
5/99 strain-1 Month after 3rd vaccination	100 (99 to 100)	2 (0 to 6)
NZ98/254 strain (Baseline)	1 (1 to 2)	1 (0.021 to 5)
1 Month after 3rd vaccination	84 (82 to 86)	2 (0 to 6)

Population analysed: Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB Lot1	70 of 832 (8.4%)	827 of 832 (99.4%)	Not reported
rMenB Lot2	80 of 828 (9.7%)	825 of 828 (99.6%)	Not reported
rMenB Lot3	60 of 820 (7.3%)	817 of 820 (99.6%)	Not reported
Routine	51 of 659 (7.7%)	652 of 659 (98.9%)	Not reported
MenC+Routine	28 of 490 (5.7%)	482 of 490 (98.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31110098Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
Derived from this study: PubMed 23324563Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.

Related trials for Serogroup B Meningococcal Meningitis

Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons

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 study chair

Novartis Vaccines

66 sites in 5 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 1 inclusion and 5 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Czechia, Finland, Germany, Italy, Austria. 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?

The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination (time frame: one month after the third vaccination). The study lists 2 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 NCT00657709, which also lists 2 linked publications.

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 Oct 2017.

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 (1 listed)

Key exclusion criteria (5 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination

Primary outcome: The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)

Adverse events

Research links

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Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons

Referral and contact

Questions about this trial

Participant flow

Primary outcome: The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination

Primary outcome: The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)

Adverse events